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Agilent 1200 Series

1. Revision ChemStation Verification Test Details Test Name C CHEM32 1 VERIFY LCAREA VAL Data File C CHEM32 Method C CHEM32 Original Datafile Original Aquisition Me Original Operator Original Injection Dati Original Sample Name Signals Tested Signal 1 ADC1 A A Example Only See your originals shipped with the product or handed over by the Customer Engineer ChemStation Verification Test Results Test Module Selected For Test Test Result Digital electronics test No N A Integration test Yes Pass Quantification test Yes Pass Print Analytical Report Yes N A ChemStation Verification Test Overall Results Pass Instrument 1 06 Mar 06 11 07 18 AM Page b ee dl 4 Operational Qualification 00 Phase Certificates showing tracebility of Agilent 1200 Series Qualification Workbook Operational Qualification 00 Phase 4 Certificates showing tracebility of Standard Caffeine Kit Agilent 1200 Series Qualification Workbook Certificate of Analysis Caffeine Standards Kit PartNo 8500 6762 Lot No 0C367446 Concentrations Caffeine in water Nominal value Effective value determined by UV spectroscopy using the absorption maximum at 273 nm mA n L 1 4 gt n L A nw Example Only see your originals shipped with the product or handed over by the Un Orage Customer Engineer Caffeine a Concentration acid titration 98 5 101 5 Heavy metals as
2. Dr Ludwig Hubei Multi Vendor Validation Program benefits A single master plan that is simplified for ease of use Harmonization of protocols to reduce effort of instrument validation Coverage of all instruments regardless of manufacturer from a single vendor Unique metrology based technique made possible by the GLP 100 a proprietary test box tool that measures the basic physical parameters of your instruments A customizable program with qualifica tions performed under test conditions and parameter ranges you design International protocol acceptance There are a variety of national and interna tional regulatory and quality standards that require laboratory equipment be validated upon installation and after upgrade or repair Agilent qualification protocols have a proven record of success in satisfying these requirements Agilent protocols have gone unchallenged in numerous audits worldwide Agilent s protocols have been designed to comply with regulations and standards such as GMP of US FDA and other agencies GLP of US FDA OECD and other agencies 21 CFR Part 11 on e records signatures ISO 17025 replaces EN 45000 45001 ISO 9000 series For more information regarding a successful compliance program Go to www agilent com chem and look up our online brochure 5 Step Concept to Successful Compliance 5988 7026EN Expert advice from the expert himself To fa
3. 18 x Ta it aE KT ca BS st x Validation opened Output settings Configuration value for t test for comparison of mean values changed From 5 Configuration value for F test for comparison of mean values changed from 5 Predefined headers edited Validation opened ity Report created ity Report created ery by s Report created tery by sj Planning very by sj Data Edit very by sj Data Edit closed with warning Validation opened Validation closed Validation opened Validation closed Validation opened ity Grahpic created Validation entire report created Validation opened F Configuration value for t test for comparison of mean values changed From 5 a Configuration value for F test for comparison of mean values changed from 5 Validation planning report created Report created Validation saved Validation opened Output settings Validation entire report created Main Peak Linearity Validation archived in Validation opened Validation opened Validation closed Validation opened Report created Validation opened Impurity A Linearity Validation opened Signature applied Checkpoint locked validation saved Output settings D a Golf 3 33PM Impurity Linearity Grouping of audit trails in this example grouped by user Audit trail details The validation and default validation audit trails display all actions tha
4. Comment Planning data Determination method Blank value method Nominal value d fo Nominal value q fo Calibration line method according to ICH Accuracy ChemStation Plus Method Validation Pack Planning Height Additional header info Header line 1 GG Header line 2 Header line 3 FX Header line 4 Header line 5 GG Data type Limit of Detection and Determination The detection limit is the smallest amount of substance which can be detected qualitatively during one analysis d statistical certainty ation limit is the smallest amount of a hich can be detected quantatively during with a statistical certainty to be tion curve method For the calculation of o values the concentration and the slope entered alue method If you select the blank value you must enter the measured values and the the calibration function zording to the ICH guideline the detection irmination limit can be calculated based on xj I 4 VQuantification Headers Product late night wake up drug Test method batch According to ICH Run number Test criterion Dimension Meas sys HPLC QS Number fantasy Device type Agielnt 1100 Device No for serial numbers see checkpoint header Comment no comment Planning data Determination method
5. Show in external word processo Validation opened C Program Files Agilent Technalogies Method Validation Pack Demo_org VDB DB ID 32 DMS Server local idle 6 9 2004 4 05 PM Start HEAR lt foms server local gx Method Valid fJuntitled Paint GJ My Pictures Sf untitled Paint 7 fia_54 Paint PE 405pm Figure 54 Executing electronic signatures with Method Validation Pack 65 Agilent ChemStation Plus Method Validation Pack Installation Prerequisites Method Validation Pack can operate both PC based in a standalone installation or in a networked system installation with full client server functionality In both scenarios some prerequisites must be met Software ChemStation Plus standalone For a fully integrated installation of Method Validation amp TTT required to have the f software installed e ChemStore standal B 03 01 or higher o Pack rev B 03 01 o e Agilent ChemStatic LC A D CE CE M rev A 10 01 or high acquisition ChemStation Plus If the system should operate in client server mode ChemStore with Oracle 9i version 9 2 0 3 0 must be installed on the system In the client server installation all ChemStation Plus modules can operate from different PCs Their installation is completely independent and the system is fully functional as long as all required modules See above are installed within this cluster and they can connect with
6. Figure 44 Comparison with nominal value Nominal value p n2 Method comparison with joined sample Method comparison Nominal value CV C Standard addition Number of values with matrix fl Extended spiking method Addition z fl C Recovery C Accuracy by recovery Nominal value CY fol Number of samples E Y Units Multiple determination TT Multiple injection Number per value 1 TU Multiple determination Number per value Comment OK Cancel ChemStation Plus Method Validation Pack Planning Height v Additional header info Data type Header line 1 Header line 2 Header line 3 Header line 4 Header line 5 Accuracy Accuracy is a qualitative concept It describes the extent of correspondence between the expected value and the conventional value Accuracy is influenced by the systematic error The systematic error is divided into a constant systematic error and a proportional systematic error A constant systematic error is not influenced by the concentration of the substance to be determined If the error is influenced by the concentration it is a proportional systematic error A qualitative measurement for accuracy is the systematic deviation of the result Comparison with the nominal value There are two tests to compare the results of the analysis with the nominal value the nominal value t test and the Wilcoxon Matched Pairs Signed Rank Test The t test tells you whether the
7. operator 5 27 00 8 44 24 PM Successfully logged on Review Client HP WBM187 support 5 27 00 8 44 24 PM Logged off Review Client HP WBM187 support 15 27 00 8 43 56 PM Modified permissions operator Review Client HPWBM187 support 5 5 27 00 8 42 48 PM Successfully logged on Review Client HPWBM187 Logged off Review Client HPWEM187 operator operator 5 26 00 4 01 29 PM 5 26 00 12 23 13 PM Successfully logged on Review Client HP WBM187 cnickel 5 26 00 12 23 13 PM Logged off Review Client HP WBM187 cnickel 5 26 00 12 21 58 PM Successfully logged on Review Client HPWBM187 nickel _ 241 cnickel _ Figure 29 5 26 00 12 20 17 PM Successfully logged on Review Client HPWEM187 5 26 00 10 40 36 4 AM Database logbook Logged off Review Client HPWBM187 Agilent ChemStation Plus Security Pack E Mail Notification The email notification feature client server only allows to send Mall server setup Mailhost mail_host_01 Port 25 an email to a configurable list of i Sender CSserver lt mail_csserver company com gt recipients on the event of e account lockout Account locked e batch submission ae e user permission change user creation To ion_admin company com For each event the reci
8. A WARNING notice denotes a hazard It calls attention to an operating procedure practice or the like that if not correctly per formed or adhered to could result in personal injury or death Do not proceed beyond a WARNING notice until the indicated condi tions are fully understood and met Agilent 1200 Series Qualification Workbook About this Book This Qualification Workbook for the AGILENT TECHNOLOGIES 1200 Series systems and modules for LC contains documents of the 4 phases of the entire instrument life in a user s laboratory Design Qualification DQ Installation Qualification 10 Operational Qualification 00 Performance Qualification PO The book will help to demonstrate e g in case of an audit or inspection that the instrument is qualified independent of its age For this purpose the workbook needs to be updated regularly The documents in the chapter Design Qualification DQ Phase demonstrate the qualification of the vendor and the instrument s functional and performance specifications Because system qualification is not a one time event Agilent Technologies has set up processes to enable qualification during the entire product life Therefore the workbook contains examples for qualification documents of the other phases of the instrument s lifetime The user must replace them with the originals at appropriate time The user should feel free to add further documents whenever he she thinks thi
9. Comment Figure 37 Checkpoint planning window example for accuracy with sections for check point header data test planning data number of results y units and multiple determination OK Cancel ChemStation Plus Method Validation Pack Planning Data type Additional header info Header line 1 Header line 2 Header line 3 Header line 4 Header line 5 ChemStation Plus Method Validation Pack Planning In this planning area the user configures the ChemStation result data type for the check point calculations For example for precision data the calculation can be either based on peak area or peak height as determined by the ChemStation Additional header information can be imported from ChemStore along with the result values Available result values are peak area peak height peak width retention time and amount or the selectivity checkpoint esolution data is obtained with lifferent calculation methods as rovided by the ChemStation tangent method according o USP EP ASTM halfwidth nethod sigma method statistical nethod Additional header nformation can be d F Height Accuracy Accuracy is a qualitative concept It describes the extent of correspondence between the expected value and the conventional value Accuracy is influenced by the systematic error The systematic error is divided into a constant systematic error and a proportional systematic error A
10. From Agilent ChemStation to ChemStore database Agilent ChemStore C S offers two modes of data transfer from the Agilent ChemStation into the Agilent ChemStore C S database e interactive mode and e automated mode Figure 2 shows the interactive mode Chemstore Single Run Setup Instrument i x Select Study Database Name demo study Info Contains data for method validation Precision of AT Precision of Peak Area Custom Fields Stored in Addition to Result Hame Unit Type Required M Chromatograms HT Tre No I Spectra for Quantified Peaks F Raw Data M Sequence Method Example Only See your originals shipped with the product or handed over by the Customer Engineer T Calculate Peak Performance Transfer Data after each Analysis only on Manual Request Help a Data transfer setup screen in the Agilent ChemStation Interactive mode Users perform the transfer manu ally from the Agilent ChemStation menu item in Data Analysis View or use the batch review interface of the Agilent ChemStation This mode of operation is useful for analysts who wish to perform a first pass data review from the Agilent ChemStation data analysis view before transferring the approved results to the database Automated mode Results are transferred automati cally to the database at the end of each run This mode ensures that all analytical data are transferred into the Agilen
11. Mean Figure 38 Planning dialog for checkpoint Precision instrument Sometimes both terms robustness and ruggedness are used interchangeable Whether or not a method is considered as robust rugged is distinguished by the fact that a change of parameters method setpoints environmental conditions instrument etc within a reasonable range has no significant influence on the result The F test and the t test can be applied as statistical criteria for the evaluation As a measure for ruggedness F3 Robustness x ChemStation Plus Method Validation Pack Planning Headers Test method Product late night wake up drug Data type Height batch Test criterion According to ICH Dimension Meas sys Additional header info Run number QS Number H PLC Header line 1 v Device type fantasy Agielnt 1100 Header line 2 GG Device No for serial numbers see checkpoint header Header line 3 no comment Header line 4 Header line 5 gt m Planning data Determination method Comparison of results Ruggedness C Comparison with reference Nominal value 6 fo e Result comparison Ruggedness is defined as the Series independence of an analytical result from changes in Number of series Number of values other parameters which could influence the result Y Units 6 Ruggedness is given ifthe
12. Nano Pump This maintenance procedure requires the following consumables Pump Head Assembly 2x Seals 5063 6589 Standard Pack of 2 or Purge Valve Assembly if pump is to be used in Normal mode 1x PFTE Frit 01018 22707 pack of 5 1x Outlet Gold seal 5001 3707 Ix Outlet Cap TL a Outlet Ball Val Mido ATA Example Only 2x Outlet Gold s see your originals 2x Outlet Cap L ar i A shipped with the product Lx Frit or handed over by the Customer Engineer Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 8 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist x Agilent Technologies G1329A Autosampler and G2260A Preparative Autosampler This maintenance procedure requires the following consumables For G1329A these parts are all included in the G1313 68730 Autosampler PM kit 1x Rotor seal 0100 1853 Vespel 1x Needle Seat i 1x Needle Example Only For G2260A see your originals 1x Rotor Seal and Stai ak Es shipped with the product 1x Needle or handed over by the Customer Engineer Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 9 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist G1367B Well Plate Sampler G1377A Micro Well Plate Sampler and G2258A Dual Loop Autosampler x Agilent Technologies This maintenance procedure requires the follo
13. C without external cooling Column switching valves are pro grammable from the software Valves The Agilent ChemStation supports external valves as well mostatted valves built umn compartment e 2 position 6 port valve option G1316B 055 up to 600bar e 2 position 6 port micro valve option G1316B 056 up to 600bar e 2 position 10 port valve option G1316B 057 up to 600bar e 2 position 6 port valve option G1316A 055 e 2 position 6 port micro valve option G1316A 056 e 2 position 10 port valve option G1316A 057 The maximum number of external valves connected to one Agilent Example Only see your originals The following external valves are supported e Agilent 1200 1100 Se tion 7 port valve G1156 e Agilent 1200 1100 Se tion 10 port valve G ____ e Agilent 1200 Series 2 positon 6 port valve SL G1158B e Agilent 1200 1100 Series 2 posi ton 6 port standard valve G1158A e Agilent 1200 1100 Series 6 posi tion selection valve G1159A e Agilent 1200 1100 Series 12 posi tion 13 port selection valve G1160A e Agilent 1200 1100 Series 2 posi tion 6 port micro valve G1162A e Agilent 1100 Series 2 position 10 port micro valve G1163A The following thermostatted valves built into the column com partment are supported shipped with the product or handed over by the Customer Engineer The Agilent 1200 Series diode array detector DAD SL G1315C and t
14. Date or Date amp Time Figure 3 Creating a custom field amp Instrument 1 offline 1 Data Analysis File Graphics Integration Calibration Repot Spectra Batch geen Data Analysis Eg tipae Pe or a default value as well upper and lower limits can be specified Custom field values are entered before the single sample or sequence acquisition e Single sample manual operation Study and custom field values are entered by a single run Agilent Chem Station menu item figure 4 e Sequence operation Study and custom field values are specified per sequence line and and stored with the sequence Agilent ChemStore C S data capabilities the lab manager ality control person can data generated on multiple nents throughout the lab as can be approved rejected ed or assigned for rework Agilent Chem Station see From database to the og t ChemStation ChemStore spooler Managing data transfer from Agilent ChemStation to Agilent ChemStore C S To ensure optimum performance of the Agilent ChemStation a background spooler takes care of a secure result transfer from the Agilent ChemStation data into the Agilent ChemStore C S database View Abort Help Single Aun Batch LE mK Figure 4 Data transfer setup screen in the Agilent ChemStation This approach has several advan tages including releasing the Agilent Chem Station to go on with other tasks qui
15. GLP features Column identification module for GLP documentation of column type see Column ldentification System in the manual Housing All materials recyclable All specifications are valid for distilled water at ambient temperature 25 C set point at 40 C and a flow range from 0 2 5 ml min Physical Specifications Table 48 Physical Specifications Type Specification Comments Weight 10 2 kg 22 5 Ibs Dimensions 410 x 435 x 140 mm width x depth x height 16 1 x 17 x 5 5 inches Line Voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption 320 VA 150 W 512 BTU Maximum Ambient operating temperature 0 55 C 32 131 F Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 48 Physical Specifications continued Operating altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the instrument Safety standards IEC CSA UL Installation Category II Pollution EN Degree 2 For indoor use only Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1330A Autosampler Thermostat Performance Specifications Table 49 Performance Specifications Agilent 1200 autosampler thermostat Type Specification Temperature range setabl
16. Minimum primary flow pump channel is 5 l min Typically 300 nl from the electronic flow control to the pump outlet for flow rates up to 4 l min For flow rates up to 4 l min and electronic flow control active primary flow path 180 480 pl system pressure dependent default settings calculated volume Typically 180 to 480 pl system pressure dependent for flow rates up to 2 5 ml min default settings calculated volume 20 to 400 bar 5880 psi system pressure User selectable based on mobile phase compressibility 1 0 8 5 solvents with pH lt 2 3 should not contain acids which attack stainless steel Upper pH range is limited by fused silica capillaries Agilent ChemStation for LC For pressure monitoring 2 mV bar one output Controller area network CAN GPIB RS 232C APG Remote ready start stop and shut down signals LAN optional 2 Design Qualification DO Phase Table 13 Performance Specification Agilent 1200 Series Nano Pump continued Safety and maintenance Extensive diagnostics error detection and display through control module and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas GLP features Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase with user settable limits and feedback messages Electronic records of maintena
17. Proposal Investigation Design Implementation Test Manufacturing Release Software Quality Assurance Quality Plan Example Only See your originals shipped with the product or handed over by the Customer Engineer Change Management Process Coding Standards Source Code a oe Printed in Germany Agilent Technologies Inc 2006 Agilent Technologies Hewlett Packard Strasse 8 76337 Waldbronn Germany 3 Installation Qualification 10 Phase ChemStation Installation Verification Report Agilent 1200 Series Qualification Workbook ChemStation Installation Verification Report ChemStation Installation Yerification e x File Help File Version FileDescription hpsched exe 32 3 0 2 Agilent ChemStation Scheduler msstatus ini Initialization startm exe 32 2 1 0 StartM apg_top exe 32 2 2 0 CAG Server executable apgdde dll 32 3 1 0 Analytical Product Group DDE Library commtask exe 32 2 1 0 CAG COM port connection process hp lc ini Initialization hp ms ini Initialization hpce ini Initialization hpced02 exe 3237 0 APG Configuration Editor hpfabs00 dll 32 3 10 support functions hpgc ini Initialization hpgthkOO dll 32 2 1 0 Generic Thunk Module hpnls01 dil 32 3 1 0 NLS Dynamic Link Library hpted_01 dil 32 2 1 0 Table Editor Control Dynamic Link Library hputil02 dll 32 3 2 0 Agilent Utility Library hsicltsk exe 32 3 1 0 APG DataComm Server iapg dil 32 2 1 0 CAG Server interface
18. customizing the Agilent ChemStation interfacing the Agilent ChemStation with LIMS upgrading from previous vj sions of ChemStation Installing and Learning Each Agilent ChemStation sc ware product comes with an installation manual that inch details of the key steps in PC hardware and software requi ments instrument interface j lation Agilent ChemStation instal lation and installation qualifica tion The installation manual is specific to the purchased configu ration and includes troubleshoot ing system records and system maintenance advice Each Agilent ChemStation includes a task based tutorial that is built into the help This tutorial is the primary learning aid and is designed to let users learn what they want at their own pace Each analytical task is divided into a number of clear guided steps each of which the users may see exe cuted automatically by the soft ware and then practice them selves Using Two additional categories of on line information are designed for the routine user The ChemStation includes com prehensive Windows style con text sensitive and indexed on line help This system gives detailed explanations of every screen and the meaning of the parameters on that screen The detailed explana Example Only see your originals ChemStation or who want to build in additional features may do so by writing macros using the command set The Commands Help file accesse
19. e For the Agilent 7683B larger turret for 2x increase in solvent and waste capacity 6890 6850 only e For the Agilent 7683B solvent saver made for 4x increase in solvent usage 6890 6850 only e For large volume injections a 100 nl syringe can be u the Agilent 7683 Series The Agilent ChemStation the user to optionally dist Sampling Diagram windovy taining a graphical display one hundred vial tray ind which samples have alrea which sample is currently and which samples will be The G1926A bar code reader attachment is supported in the 100 vial tray configuration of the autosampler The bar code reader can be used to help build automa tion sequences and verify that the identity of the injected sample matches the name in the sequence table at injection time The new G2615A bar code reader is used with the 7683 automatic liquid sampler tray The Agilent ChemStation can acquire a third and fourth signal from external detectors in a single run by adding the 35900E A D converter Agilent GC ChemStation Companion The Agilent ChemStation Companion provides the user with a simple single screen user inter face for GC routine analysis In the Companion View the user is limited to selecting pre pro grammed samples methods vial numbers and run control Users cannot modify or create any meth ods or run any methods or sam ples not assigned to them by their lab manager The Agilent ChemStation Companion
20. Agilent 1200 Series ig Agilent Technologies Notices Agilent Technologies Inc 2006 No part of this manual may be reproduced in any form or by any means including elec tronic storage and retrieval or translation into a foreign language without prior agree ment and written consent from Agilent Technologies Inc as governed by United States and international copyright laws Manual Part Number G1310 90300 Edition 02 06 Printed in Germany Agilent Technologies Hewlett Packard Strasse 8 76337 Waldbronn Germany Microsoft is a U S registered trademark of Microsoft Corporation Warranty The material contained in this docu ment is provided as is and is sub ject to being changed without notice in future editions Further to the max imum extent permitted by applicable law Agilent disclaims all warranties either express or implied with regard to this manual and any information contained herein including but not limited to the implied warranties of merchantability and fitness for a par ticular purpose Agilent shall not be liable for errors or for incidental or consequential damages in connec tion with the furnishing use or per formance of this document or of any information contained herein Should Agilent and the user have a separate written agreement with warranty terms covering the material in this document that conflict with these terms the warranty terms in the sep arate agreem
21. Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G2260A Preparative Autosampler Performance Specifications Table 19 Performance Specifications Agilent 1200 Preparative Autosampler G2260A Type Pressure GLP features Communications Safety features Injection range Replicate injections Precision Minimum sample volume Carryover Sample viscosity range Sample capacity Injection cycle time Agilent 1200 Series Qualification Workbook Specification Operating range 0 40 MPa 0 400 bar 0 5800psi Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN GPIB IEEE 448 RS232C APG remote standard optional four external contact closures and BCD vial number output Leak detection and safe leak handling low voltages in maintenance areas error detection and display 0 1 900 ul in 0 1 ul increments recommended 1 ul increments Up to 1800 pl with multiple draw hardware modification required Up to 5000 ul with multiple draw hardware modification required 1 99 from one vial Typically lt 0 5 RSD of peak areas from 5 2000 ul Typically lt 1 RSD of peak areas from 2000 5000 ul Typically lt 3 RSD of peak areas from 1 5 pl 1 ul from 5 pl sample in 100 ul microvial or 1 ul from 10 pl sample in 300 pl microvial Typically lt 0 1 lt 0 05 with external needle cleaning 0 2 50 cp
22. C 4 to 158 F Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 12 Physical Specifications continued Humidity lt 95 at 25 to 40 C 77 to 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the autosampler Safety standards IEC CSA UL Installation Category II Pollution Degree 2 Agilent 1200 Series Qualification Workbook G2226A Nano Pump Design Qualification DQ Phase 2 Performance Specifications Table 13 Performance Specification Agilent 1200 Series Nano Pump Type Hydraulic system Settable column flow range Recommended column flow range Optimum composition range Composition precision Delay volume Pressure range Compressibility compensation Recommended pH range Control and data evaluation Analog output Communications Agilent 1200 Series Qualification Workbook Specification Two dual piston in series with proprietary servo controlled variable stroke drive floating piston active inlet valve solvent selection valve and electronic flow control for flow rates from 0 1 to 1 l min 0 01 4 pl min 1 2500 ul min with the electronic flow control bypassed 0 1 1 l min 200 2500 pl min with the electronic flow sensor bypassed 1 to 99 or 5 l min per channel primary flow whatever is greater lt 0 2 SD at 500 nl min default settings
23. Sufficient for two 10 foot lengths Remote Diagnostics Phone One analog phone line is recommended to provide remote diagnostics capability for the LC MSD A second phone line is also strongly recommended for communication with the system operator a Example Only See your originals shipped with the product or handed over by the Customer Engineer Issued Feb 2006 Rev 2 0 Copyright 2005 Agilent Technologies LC MS Technical Marketing Page 3 of 3 3 Installation Qualification 10 Phase Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2170BA G2171BA G2180BA Software Site Preparation Specification B 02 01 Agilent 1200 Series Qualification Workbook Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2170BA G2171BA G2180BA Software Site Preparation Specification B 02 01 Purpose of Procedure To assure that the installation of Agilent instruments and systems can be completed successfully by careful preparation and evaluation of the installation site and by ensuring the availability of appropriate utilities consumables and supplies Customer Responsibilities Customers should ensure that all necessary operating supplies consumables and usage dependent items such as columns vials syringes and solvents required for the successful installation of instruments and systems are available Installation sites be prepared in accordance following specifications Imp
24. area mean area mean stdy L Mixture 2 Mixture 1 1263 446533 1170 614225375 24 8806221158832 6 218948 Cd IMituet4 y Mixture 2 E Mitue 5 LL id B test 1 table l area ratio table l Barbital Peak Area table 1 Allobarbital Peak Area IF table l area ratio lt 1 03 THEN table l check pass ELSE table l check fail FROM table 1 SELECT Sample Sample Name Peak Area FOR Barbital INTO table 2 GROUP table 2 BY Sample Sample Name DO mean Barbital Peak Area AS area mean rstdev 4 gt Col6B Ready B Errors 38 Overflow GROUP table 2 BY Sample Sample Name DO meani Barbital Peak Area AS area mean rstde figurable result output such e Group allows to group by a minimum value as pass or fail specific data item and do relative standard deviation e Format defines the number statistical group calculations standard deviation format and precision of data such as sum and items for reporting number of values count variance e Transpose allows to transpose a table or subtable 12 maximum value mean value The expression wizard figure 9 is used for defining a calculation which can be either an expression or condition Calculations can be defined for all available columns or variables It provides a set of arithmetical and statistical functions t
25. file set points source O Note any obvious external damage O Inspect corona needle holder for or problems oxidation or physical damage i e 6172454 AF 1 HIectrospray source j G1948A API Electrospray Source springs on needle holder Perform source maintenance on currently O Inspect needle receptacle for _ Q Allow the source to cool completely installed source only oxidation or physical damage i e cracks inside source Q Clean the lamp window with a lint Q Record serial number Inspect nebulizer and needle for free cloth and methanol physical damage i e damaged tip i or corrosion Q Check that lamp lights Note O Perform general Miopeco of API O Note any obvious external damage Replacements S APPI lamp is not NS SOLI or problems covered during the PM procedure O Inspect Vented Standoffs for chemical deposits or physical damage Q Replace and properly adjust nebulizer OW Replace the APCI corona needle needle G1946 60190 O Inspect nebulizer and needle for G1947 20029 physical damage 1 e dents or corrosion U _ Using the grey abrasive cloth a brasively clean the bottom of the O Note any obvious aporizer can and then wipe with a or problems Example Only nt free cloth with methanol see your originals ec e Q Remove mesh assembl oray chamber including the window abrasive cloth followe sh l p p e d with th e p ro d u ct nth a lint free cloth with methanol a lint free cloth with m
26. iwacos dll 32 2 1 0 CAG Server interface larpalan dll 32 2 1 0 CAG LAN Server link dll lhpbsicl dll 32 2 2 0 CAG DataComm Server licop ini Initialization Irs232 dll pt fe mfc71 dil mfc71u dil msvcp71 dil msvwer71 dil papg dil Example Only pren di See your originals res_mgr dll server dll shipped with the product or handed over by the core agilent chemstation ui dialogs preferences c core agilent chemstation ui navigationbar dll core agilent chemstation ui toolbars dll core agilent chemstation ui navigationtable dll core bspproxylib dll core coreconf reg core cstools exe core cstools ini core chemmain exe core chemmainremoting dll 0 0 1 6 core cpproxylib dll 0 0 1 15 core dgguireg reg Register core devexpress data3 dll 3 2 4 0 core devexpress utils3 dll 3 2 4 0 core devexpress xtrabars3 dll 3 7 4 0 core devexpress xtraeditors3 dll 3 2 4 0 core devexpress xtragrid3 dll 3 2 4 0 core devexpress xtranavbar3 dll 2 7 4 0 x Customer Engineer Installation Qualification I0 Phase 3 Customer contributed documents Agilent 1200 Series Qualification Workbook Agilent 1200 Agilent 1200 Series Qualification Workbook 000 ee 4 Operational Qualification 00 Phase 00 PV Protocols Agilent ChemStation Verification Test Report Certificates showing tracebility of Standard C
27. maximum capacity GLP features interfaces safety features Specification 48 mm with long needle assembly G1367 87200 75 mm with short needle assembly G1364 87202 ca 20 ml with 48 mm test tubes ca 30 ml with 75 mm test tubes or unlimited if funnels are used with external containers 10 ml min depending on viscosity and generated back pressure max 6 bar at the diverter valve The analytical scale fraction collector can be modified for flow rates gt 10 ml min Fraction collector inlet to diverter valve 50 typical depends on the length of the tubing Diverter valve 15 Diverter valve to needle 10 Needle 4 Single wavelength absorbance detector working at 654 nm consisting of a LED and a photo diode 3 2 Diverter valve with low internal volume 15 ul switching time lt 100 ms maximum operating pressure 6 bar Optional with additional G1330B performance depending on ambient conditions and the volume of collected fractions 3 fraction collectors in parallel plus one recovery fraction collector connected via 12 Position 13 Port Selector valve PN G1160A Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN optional LAN or external contacts interface RS232C APG remote for remote start stop signals to from other modules Interface to G1330A Thermostat CAN DC out for operation of Agilent approved external devices like
28. 18 cm 7 in 43 5 cm 17in 34 5 cm 13 5 in G2226A Nano Pump G1322A G1379B Degassers 7 5kg 16 5 lbs G1361A Preparative Pump 15 kg 32 9 lbs 20cm 8in 43 5cm 17in G2258A Dual Loop i in 34 5 cm 13 5in Autosampler i POSSO g ESA tae G1329A G2260A Autosamplers Example Only G1367B G1377A High See your o ri g inals i Performance Autosamplers ee Agilent Technologies G1330B ALS Thermostats shipped with the product i 13 5 in G1316A Thermostatted Columi 41 cm 16 in Compartment or handed over by the G1314B C Variable Wavelengtl E i 34 5cm 13 5 in Detectors Customer Engineer G1315B C Diode Array di 34 5cm 13 5 in Detectors G1365B C Multiple Wavelength 11 5 kg 26 lbs 14 cm 5 5 in 43 5cm 17in 34 5cm 13 5 in Detectors Detector Collectors Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 2 of 8 Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification RIO Environmental Conditions C Operating the LC System within the recommended temperature ranges insures optimum instrument performance and lifetime Performance can be affected by sources of heat and cold from heating air conditioning systems or drafts Please Note The site s ambient temperature conditions must be stable for optimum performance of the system s modules as specified in the Performance Specifications section of each module s Reference Manual Temperat
29. 2 Diagnostics and Tests Screen Maintenance Diagnostics Q Review common maintenance procedures by reviewing the Simple Repairs section in the propriate Reference Manual r Systems that do not have control Module detailed miliarization of the 1200 set ints will be covered in the MIT METHOD and AGNOSTIC portions of the ftware Familiarization Page 1 of 3 Agilent 1200 Series Liquid Chromatograph Familiarization Checklist Software Familiarization Q Section Not Applicable System Startup Q Demonstrate switching on instruments PC and peripherals Q Demonstrate starting Windows operating system logon password Q Demonstrate starting LC ChemStation software Q Describe ChemStation Configuration Editor Q Describe Online and ffl General Familiarization E E Q E Q a T p f session collection order and mode needle movement Edit Method Q E E Q Prepare a method using the Edit Entire Method menu item to analyze the checkout sample Don t forget to explain parameters under the More and Auxihary Buttons or Menus If the Spectral Software G2180BA is loaded select acquisition of all spectra Save the method as ISO_1 M Exnlain the difference between Example Only Describe software ma Demonstrate Online I Tutorial Demonstrate the Chei layout Explain use of the vai Views and the usage Navigation Pane Explain ChemStation Explorer Explain Packagin
30. A customized reporting design view is included in the Chem Ctatian far 1eare urha xxrant ta Example Only see your originals shipped with the product or handed over by the Customer Engineer 4 LIUUUI VI I m9 ILZU ALLA VIIN 1LUUL tion of each defined element The individual sections may be added deleted re ordered and nested Utilities and Compatibilities General The ChemStation can import and export data files in the ANDI Analytical Data Interchange chromatography format of the Analytical Instrument Association AIA revision 1 0 copyright 1992 Data import is supported at com pliance level one sample informa tion and signal data and data export at compliance level two sample information signal data and integration results The ChemStation includes com mands and functions to support the Dynamic Data Exchange The user may define headers and footers to appear on every page time stamps for the report and page numbering in the page x of y format The information includ ed in the report may be any ChemStation or user defined para meter Once the report has been designed it may be associated with a partic ular method to make it the default report format for that particular type of analysis Customized reports may be output to the screen a printer or a file the screen include nart Reports hart feature is includ ChemStation software ature is installed and
31. Agilent 6890 Gas Chromatograph Agilent 5890 Gas Chromatograph Agilent 1090 Series LC systems Agilent Capillary Electrophoresis CE Agilent Capillary Electrophoresis Mass Spectrometry CEMS HP 1046 FLD HP 1049 ECD HP 1090 LC USB GP IB Interface Instruments supported USB GP IB USB port oi used e Agilent Capillary Electrophoresis CE e Agilent Capillary Electrophoresis Mass Spectrometry CE MS e HP 1046 FLD e HP1049 ECD e HP 1090 LC 82350A B GP IB Interface Cards Analytical instruments can com municate with the Agilent ChemStation via GPIB using a GPIB board installed in the com puter Agilent 82350A or 82350B PCI high performance GPIB inter face cards can be used on Ar To ADANI AIN 1 wre 2 a Example Only see your originals shipped with the product or handed over by the Customer Engineer cards a PCI slot is required on the PC The Agilent 82350 is a PCI GPIB interface card and no addi tional settings such as changing the I O base address are required Please note that GPIB communi cation requires installation of the SICL I O library version M 01 01 pee ask your local Agilent les representative for details idle G1602BA Option an internal support part 200 from the Support ae sus GPIB instruments The interface is small portable flexible uses industry standards and is easy to connect The interface can be used on both Windows 2000 and Windows XP Professional
32. Canada ICES NMB 001 1998 The product was tested in a typical configuration with Agilent Technologies test systems 1200 Series module with LAN Communication Interface attached IEC 61010 1 2001 EN 61010 1 2001 Canada CSA C22 2 No 1010 1 1992 A2 1997 USA UL3101 1 Supplementary Information This ISM device complies with Canadian ICES 001 Cet appareil ISM est conforme la norme NMB 001 du Canada This DoC applies to above listed products placed on the EU market after December 19 2005 7A bi GE Date Wolfgang Wilde Quality Manager For further information please contact your local Agilent Technologies sales office agent or distributor or Agilent Technologies Deutschland GmbH Herrenberger Stra e 130 D 71034 B blingen Germany locument No G1311 Doc 11 90510 DLL ON AIN KAMA Revision A Figure 2 Declaration of Conformity Every AGILENT TECHNOLOGIES ChemStation is shipped with the e Declaration of System Validation figure 3 The document declares that the AGILENT TECHNOLOGIES ChemStation software was developed tested and successfully validated according to the Software Life Cycles and Quality Manuals followed by the solution units of the AGILENT TECHNOLOGIES Life Science and Chemical Analysis Group Agilent 1200 Series Qualification Workbook 1 1 Overview Although the declarations belong to the DO phase we have added an example copy of each to the chapter Installation Qualification
33. Integration Result Information The ChemStation is operating in Security Mode The integration results will not change if you LCFile 1 File Path Date 4 Sample __Sample Into Barcode results to the ChemStore Database by using the integrate button in the batch tool bar Sample Vial SampleType Run DataFile Isocratic Std 5 Control 3 005 0103D Isocratic Std 6 Sample _4 006 0201 gt Isocratic Std 7 Sample 5 007 0301 0 draw a new baseline or change integration events To see the difference you have to transfer the new I Results have been modified in datafile 005 0102 D New results will be stored in ChemStore from a set of predefined comments or a free text or a combination of both After finishing the data reanalysis and closing the batch review interface the temporary files will be deleted from the local hard disk Height Width Symmetry 2 2 Results are identical Figure 22 Result calculation and automated versioning 92 ChemStation Plus Security Pack Electronic Signatures and Password Security 21 CFR Part 11 permits the use of electronic signatures if the appli cation ensures data integrity data security and full audit trail docu Reenter your login name ubober mentation If an electronic signa Reenter your password fo 1 ture is supposed to be equivalent CETTE contain at least tw
34. LSM Marketing Homepage for the compatibility matrix Product Support Plan http Asbu marketing agilent com article ashow asp article_1d 710 Rev A Rev B Upgrades All Add On Products need to be uninstalled BEFORE upgrading t B 02 01 ChemStation General LJ ChemStore Q ChemAccess LJ ChemStation Plus Security F QI Other For LC LC MS systems only Q Purify Software LI Active Splitter LU G1979A Multi Signal Output Accessory Side Box Analyst Easy Access Data Browser O LU O LU Other __ Issued Feb 2006 Rev 1 0 For GC systems only LJ Companion LJ Retention Time Locking LJ HeadSpace Q Other ChemStation System Customization Check for customized solutions Example Only See your originals shipped with the product or handed over by the Customer Engineer ChemStation structure point customer to the available documentation Copyright 2006 Agilent Technologies CHE Agilent Technologies Additional Familiarization Upgrades from Rev A to Rev B ChemStation Q Explain the modified ChemStation structure e g ChemStation ini LJ Outline the new integrator features LJ Outline the integrator changes and inform about the available documentation LJ Outline the change for the old spectra tool and inform about the lable documentation tailed information regarding the ration spectra update macro ges etc can be found in the erade Preparation Guide f
35. Q 2 Record model numl OF han ded OVET by th Customer Engineer O 2 Record serial nba Column Compartment with IPA for 5 minutes Then Cap outlet of Column Compartment with Q Replace rotor seal blanking nut and perform a built in Q Replace the needle and the needle Pressure tesk seat assembly for all samplers except for the G2258A DLA For the DLA this only has to be Result Pass Fail performed if the needle is bent or needle needle seat are leaky Must O Perform thermostat test be billed separately as a repair Q Inspect G2258A DLA capillaries and tubings for kinks and damages Result Pass Fail and replace if necessary must be lara de sa ately la n ad an QO Purge LC System with HPLC DE SEP oe me PES USER grade water for 10 minutes cartridge QO Check that the ALS thermostat unit drain tube is positioned correctly 1f VALVES applicable QO Purge Autosampler and Column O 1 Record model number Compartment with IPA for 5 min Q Ifthe Column Compartment contains a Column Switching Valve Cap outlet of ALS with blank nut Otherwise Cap outlet of Q 1 Record serial number rt a ee Agilent Technologies O 2 Record model number O 2 Record serial number Record model number Record serial number 7A G1158A G1159A OA eplace rotor seal and stator face Q Inspect valve fittings and capillaries for leaks G1162A G1163A Replace rotor seal O Inspect valve fittings and capillaries for leaks DET
36. database without a first set of data analysis results data is acquired in acquisition only mode The ChemStore C S ODBC spooler is a proprietary tool managing the transfer and protecting data against loss modification or damage in case of transfer problems or network errors 26 shipped with the product or handed over by the Customer Engineer stored in a single database file The subdirectory storing the database files is protected with Windows file security permissions and only allows write access for members of the Windows user group The application denies access to data without a valid ChemStation Plus user id and password Any attempt to access the data in the standalone database directly with another application such as MS Access fails as it requires a pass word user id combination that is strictly confidential and only known by Agilent It is not known by or given to any Agilent customer or user of this product client server installations of emStation Plus Security Pack rect uncontrolled access to data iu the Oracle database without using the ChemStore user interface is virtually impossible This is because users must have a valid Oracle user account and they must have access to the data dic tionary describing the meaning and contents of the Oracle tables and table columns The dictionary is only available from Agilent Technologies against a written Confidentiality Agreement and should not be available
37. help e get your system up and running fast resolve problems quickly keep productivity high extend instrument life and comply with regulatory quality requirements Qualification services e Agilent Technolog s offerc o full range of qualif services to provid you need to satisfy requirements from such as the U S Fi Drug Administrati U S Environmenta Agency EPA the Standardization O ISO and the Org Economic Cooperutrorrana Development OECD e Installation qualification IQ service e Operational qualification performance verification OQ PV service Training Agilent s ISO registered trainings can save you time help keep your laboratory operating costs low broaden your capabilities and ensure that your laboratory complies fully with regulatory and quality requirements For your convenience standardized courses are offered in selected locations worldwide Onsite courses can be tailored to your specific needs Example Only See your originals shipped with the product or handed over by the Customer Engineer asoy agilent com chem cds ormation in this publication is subject to gt without notice oft and Microsoft Windows are U S red trademarks of Microsoft Corp is a trademark of RSA Data Security Inc is a U S registered trademark of Oracle Copyright 1999 2004 Agilent Technologies Inc All Rights Reserved Reproduction adaptation or translation without p
38. ne within the Method Validation ck andis similar to the study figuration in ChemStore They 1 select to Save raw data with results Delete raw data on the local hard disk after transfer to the database Save method and sequence along with results e Save chromatogram and spectra pictures with the result In a 21 CFR Part 11 validation all these functions are enabled for the data management options and cannot be disabled The validation report includes a marker which clearly indicates whether the validation was a carried out unter 21 CFR Part 11 conditions or under less stringent conditions as a development validation If the decision was made to run a validation in development status in order to reduce the amount of information stored in the database and logged in audit trails this decision cannot be revised at a later stage A development validation cannot be promoted to a 21 CFR Part 11 validation ChemStation Plus Method Validation Pack User Management and Access Rights Based on the hierarchical struc The user levels are part of the ture of the Method Validation ChemStation Plus user administra Pack software the system has five tion as shown in figure 48 They user levels They are are centrally configured and administered in the ChemStore 1 Reporting Logging into the database All users have two system with a name and a pass identification components user ID word of level 1 reporting gives and pas
39. of the user privileges assigned for the operating system e an application specific session lock allowing to explicity lock one ChemStation session while leaving a second instance running on the same PC and e aconfigurable time based application lock to lock the current ChemStation or ChemStore session after a specified times thus avoids an access to the e A completely revised ChemStation operator access level which allows operating the entire application as ChemStation operator e A configurable access to the ChemStation commandline independent of the ChemStation user level thus also preventing access for ChemStation managers e A modified batch review interface providing an automat ed_user indenendent data ver Example Only see your originals shipped with the product ChemStation or handed over by the Customer Engineer Client hardware requirements The following list shows the mini mum hardware requirements for this application e 600 MHz Pentium III Pentium IV recommend e 4 GByte of free hard disk space e 128 MB RAM for single Chem Station instrument 256 MB is recommended for best perfor mance for Windows XP minimum requirement is 256 MB e 256 MB RAM for two Chem Station instruments 512 MB or more is recommended for best performance e Display 1024 co 768 small fonts 65 thousand colors Client software requirements The following list shows the mini mum software requi
40. only Agilent 1200 Series Qualification Workbook Design Qualification DO Phase Table 31 performance Specifications Agilent 1200 Series PREPARATIVE SCALE Autosampler G1364B continued Type Specification test tube plate sizes Maximum tube volume Maximum flow rate Delay volumes ul Delay calibration sensor Diverter valve cooling maximum capacity GLP features Interfaces Safety features Minimum 48 mm to 100 mm maximum ca 45 ml 100 ml min depending on viscosity and generated back pressure max 6 bar at the diverter valve Fraction collector inlet to diverter valve 500 typical depends on length of the tubing Diverter valve 15 Diverter valve to needle 110 Needle 5 Single wavelength absorbance detector working at 654 nm consisting of a LED and a photo diode 3 2 Diverter valve with low internal volume 15 ul switching time lt 100 ms maximum operating pressure 6 bar Optional with additional G1330B performance depending on ambient conditions and the volume of collected fractions 3 fraction collectors in parallel plus one recovery fraction collector connected via 12 Position 13 Port Selector valve PN G1160A Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN optional LAN or external contacts interface RS232C APG remote for remote start stop signals to from other modules Interface to G1330A
41. operator instrument PC or sequence name The sequence parameter set may be defined to use automatically named data files or sequentially numbered ones with defined prefix of up characters The user run full analyses or o cessing only sequenc also select one of as nique specific shutdc mands or a user defil macro that runs whe sequence terminates error or after all the completed The sequence table or list of analyses to run is built in a spreadsheet like user interface that allows users to specify vial numbers and sample names analysis methods sample quantifi cation parameters including sam ple amount a multiplier and dilu tion factor calibration specifica tion a data exchange parameter LIMSID and the number of repeat injections Depending on the configured instruments and modules additional fields will accessible For example if an Agilent 1200 1100 LC system includes a fraction collector the Fract Start colum will appear in the sequence table The user can configure the columns to be dis played in the sequence table as well as the individual column widths The user can jump between individual cells in the table and copy cut or paste indi vidual cells or entire rows or series of rows in order to build sequences efficiently and quickly A sequence table can easily be created or changed using the fill down wizard function The sequence import wizard allows the import of sequences fr
42. optional for all pumps except the Quat Pump G1311 IT Pump ing device Example Only See your originals shipped with the product or handed over by the Customer Engineer n collector a Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page of 8 Agilent 1200 Series i 4 277 Agilent Technologies Liquid Chromatograph Hardware Site Preparation Specification Figure 4 Recommended 2 Stack Configuration with Fraction Collector Preparative Scale System Example Only see your originals shipped with the product or handed over by the Customer Engineer lt lumorganizer ai meindes lec Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 8 of 8 Installation Qualification I0 Phase 3 Agilent 1200 Series LC MSD G1956A B G2908BA G3218AA G3218BA Site Preparation Specification Agilent 1200 Series Qualification Workbook Agilent 1200 Series LCIMSD G1956A B G2908AA G2908BA G3218AA G3218BA Des Agilent Technologies Site Preparation Specification Purpose of Procedure To ensure that the installation site 1s properly evaluated and prepared with the appropriate utilities consumables and supplies for the successful installation of Agilent instruments and systems Customer Responsibilities Customers should ensure that all necessary operating supplies consumables and usage dependent it
43. refer customer to o Customer En gineer maintenance sector sample methods an Gares d installed with the software LI Explain Agilent Support services and how to obtain help note if customer requires further information Issued Feb 2006 Rev 5 0 Copyright 1995 Agilent Technologies WAD Product Support Page 2 of 2 Installation Qualification I0 Phase 3 A PE n ar K IIST LLA AASIAS Familiarization L Familiarization Checklist Agilent 1200 Series Qualification Workbook 3 Installation Qualification 10 Phase Agilent 1200 Series Liquid Chromatograph Famliarization Checklist Agilent 1200 Series Qualification Workbook Agilent 1200 Series Liquid Chromatograph Familiarization Checklist Hardware Software Hardware Familiarization Familiarization Q Section Not Applicable Purpose of Procedure To demonstrate the steps required to perform a basic analysis using a standard sample or internal data file evaluate the resulting data and perform routine operational maintenance Familiarization is intended to give operators a basic overview of the operation and maintenance of new instruments systems and aj software and is not designe substitute for a full operato course System Overview and Hardware Familiarization Q Power on each module and describe the various states of the status indicators O Indicate the installed modules in the following list that will be covered as part of the familiarization E
44. service professionals available upon request Each service professional carries calibrated and traceable tools testing equipment and standards for the rigorous tests needed to verify instrument performance For these reasons Agilent is recognized as the premier supplier of compliance products and services around the world It is a reputation that has been earned audit after audit lab after lab Agilent can provide your lab with the tools knowledge service and support necessary to keep it operating smoothly and efficiently It s our mission to keep you on your mission and to keep you cool when things heat up Agilent can t eliminate the need for compliance but our blanket of support can help smother any potential fires To obtain detailed information about Agilent s qualification and support services please call 1 800 227 9770 inthe U S and Canada In other regions of the world please contact your Agilent Technologies sales office and ask for a chemical analysis representative Agilent Technologies Inc 2002 The information in this publication is subject to change without notice All rights reserved Reproduction adaptation or transla tion without prior written permission is prohibited except as allowed under the copyright laws M icrosoft is a U S registered trademark of M icrosoft Corporation Printed in the USA J une 21 2002 5988 6910EN cdr Agilent Technologies 1 Overview Agilent s line of p
45. the system s logbook an ex of which is stored with eve file The instrument conditions as flow temperature press solvent composition for liq chromatographs may be re and stored with each data fi These instrument parameters Can be displayed and plotted to testify to the quality of each analysis The exact nature of the parame ters recorded depends both on the technique and the capabilities of the configured instrument One or more display windows may be used to monitor the data being acquired by the instrument in real time The data are dis played in real measurement units such as mAU Volts degrees or bar The windows may each show multiple overlaid chromatograph ic signals or instrument parame ters such as pressure The display default settings may be adjusted and are remembered by the sys tem so users can set their own preferred settings as the instru ment default The window has zoom capability and the cursor may be used to display a specific signal s response at any point in time The complete functionality of the ChemStation can be used during Example Only see your originals shipped with the product or handed over by the Customer Engineer the components of the Schematic instrument interface diagram is saved automatically Data Analysis Display The data analysis view extends the font for the RT and com the standard tool bar with task pound labels adjust the size grouped data analysis
46. those templates acci your needs or create e Export selected dat be sent to an Excel file or to an applicat supports cut and pa appropriate format _ e Execute custom calculations such as cross run or cross com pound calculations or advanced statistical calculations Pre defined templates can be modified or new ones can be created Modifications are stored as new template version Calculation tables and charts of calculated values can be integrated into the report e Set up a batch by marking runs whose data and method are to be transferred back to the Agilent ChemStation for re analysis e Filter or exclude any run in the current data set e Approve or reject runs based on your result review Both steps follow the FDA require ments for electronic signatures The standard query builder of ChemStore C S provides fast access to the commonly used database fields for fast and easy data retrieval For more sophisti cated queries the advanced query builder provides for access to all database fields conditional query capabilities as well as the use of variables for the operator name currently logged on user and the date for example not older than 2 days Performina statistics Example Only See your originals shipped with the product or handed over by the Customer Engineer number minimum maximum sum mean variance standard deviation J J J J J e relative stan
47. tick marks baselines and axes The user may also select the annotation fonts graphical orientation size and whether the graphics are overlaid or separated If the ChemStation is connected to instruments that can record instrument parameters as a sig nal such as temperature flow and pressure the user may also select to include these graphics in the report e Calibration table and calibration graphics Reports may be output to either the screen printer or file If tha ceraan ie calacetad ac tha Example Only see your originals shipped with the product or handed over by the Customer Engineer Wwe EWU BEEWVWER U ULLIUNLIL WEED LV LLLLUUU LULA LU report TXT The report text is printed as a UNICODE text file EMF Each report graphic sig nal or calibration curve is saved in a Microsoft Windows metafile EMF Several EMF files for one report are possible The generated file format adheres to the Microsoft enhanced metafile for mat as defined in the Windows software development documenta tion These files are compatible with the Aldus Placeable Metafile APM format used by a number of proprietary software packages DIF The tabular report data is saved in Data Interchange Format DIF This format is accepted by spreadsheet programs such as Microsoft Excel Independent from the report style selected only the information contained in the report style Short will be saved CSV The report i
48. 03 01 Agilent ChemStore C S standalone database then migrate from there to the Oracle database 19 Agilent ChemStore C S Product Options and Configurations Standalone version The complete Agilent ChemStore C S standalone software is provid ed on the Agilent ChemStation Plus CD ROM as described in table 6a Agilent ChemStore C S server The Agilent ChemStore C S server product includes the ChemStation Plus CD ROM and Oracle 9i revi sion 9 2 0 3 0 software on a sepa rate CD ROM offering one Oracle standard edition license_In_addi tion an application sJ user license is requir from Agilent for eacl user running a Chem client Five applicatic named user licenses shipped with the product Description Product No Software module to add Agilent ChemStore C S to an existing ChemStation for GC LC LC MSD CE CE MSD or A D G2181BA License to use the ChemStore C S database module on another computer G2186BA Must either be on the same order as G2181BA or the customer must supply the license number for the original software Does not require ChemStation ChemStation Plus client upgrade software upgrades a single ChemStation G1657A Plus client to the latest software revision Requires valid software licenses and ChemStation upgrade software G1656A Table 6a Agilent ChemStore C S standalone version n Product No Exa T1 ple Only C S server software G1410A ec ned user licenses Oty 1 per server See your origi
49. 10 Phase Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification Agilent 1200 Series Qualification Workbook Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification us Agilent Technologies Purpose of Procedure Your site must meet this specification or set of requirements to assure a successful and timely installation of your Agilent instrumentation This document is designed to prevent delays during installation familiarization and the initial use of the system in your application This document outlines the supplies consumables space and utility requirements for a 1200 LC It also recommends tools and consumables that may help you get started Use this document along with the 1200 Installation documentation and Consumable Catalog This information is also available from Agilent Technologies Inc s website http www agilent com Customer Responsibilities Make sure your site meets this specification including the necessary space electric outlets gases tubing operating supplies consumables and other usage dependent items such as columns vials syringes and solvents HPLC Grade Isopropanol Acetonitrile and water required for the successful installation of instruments and systems If Agilent is delivering installation and familiarization services users s aerwise they will miss important operational maintenance and Ex am p e O n ly Important Information
50. 100 x 2 ml vials in 1 tray 15 x 6 ml vials in tray Agilent vials only Typically 50 s depending on draw speed and injection volume 2 Design Qualification DO Phase G1367B High Performance Autosampler and G1367C High Performance Autosampler SL Performance Specifications Table 20 Performance specifications Agilent 1200 Series High Performance Autosampler and Agilent 1200 Series High Performance Autosampler SL Type GLP features Communications Safety features Injection range Precision Pressure range Sample viscosity range Sample capacity Specification Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN RS232C APG remote standard optional four external contact closures and BCD vial number output Leak detection and safe leak handling low voltages in maintenance areas error detection and display 0 1 100 ul in 0 1 ul increments Up to 1500 ul with multiple draw hardware modification required Typically lt 0 25 RSD from 5 100 pi Typically lt 1 RSD from 1 5 ul variable volume G1367B up to 400 bar 5880 psi G136 C up to 600 bar 8700 psi 0 2 5cp 2 x well plates MTP 10 x 2 ml vials 108 x 2 mL vials in2 x 54 vial plate plus 10 additional 2 mL vials 30 x 6 mL vials in 2 x 15 vial plate plus 10 additional 2 mL vials 54 Eppendorf tubes 0 5 1 5 2 0mL in 2 x 27 Eppendorf tube plate Also compatible with the Agi
51. 12 20 Bemhard Etrich Active __ archivequery3 1 weekly archivequery4 G archivequery5 3 weekly 2003 03 01 Administrator Inactive 2003 04 01 Administrator 2003 04 01 Ute Bober Active Active Figure 13 Setup of automatic archive queries 17 Each archive query is stored under a unique user defined name and can be executed based on a configurable time interval per query for example daily weekly monthly or in conjunction with a counter such as every x days A test functions allows the user to obtain information on the number of runs that the query returns at the moment with the given query condition For each archive query the name and path for the archive unit have to be specified The filename for the automatic archive file is appended with the archival date resulting in a file name format lt filename gt yyyy mm dd Each archive query can be disabled when not required permanently After successful completion of the archive the data can be automati cally deleted to create free space in the database Both manual and automatic archival require re identification with user ID and password Example Only Agilent ChemS See your originals shipped with the product ChemStation Plus c connected to a Lab Information Manag LIMS For this pu Agilent ChemStation provides for a sample list import function to conveniently translate a work list from the LIMS into a Chem
52. 12 AM 6 7 2004 GMT 01 Rebuild DMS TOC List __ Listverions Docs 2 Entries 277 Status ok DMS Info Search Ci IV Include all document H01 xY123456 H02 XY123456X HPLC Method Method Validation Pack document management system DMS A click in the checkbox of a section offers review of any document revision Clicking a version child node once displays its properties Double clicking a validation VDB file or clicking on its selection field will restore the selected version Documents and MVS files can be displayed in a review window allowing to zoom print export or copy the selected document The actions depend on the type of entry docu ments are displayed in j window validations ar the file system DMS with standalon Standalone systems wi require managing mult bases The system will user to create a new DI file after the size limit is exceeded A DMS or that has passed its size limit can still be selected for review If the system has more than one DMS database the user is automatically connected to the current DMS as shown in figure 50 If there is a need to review old data the user has to select the DMS database from the dropdown list of available database to connect to it The DMS databases are sorted and named by date DMS for client server systems Client Server system using an Oracle relational database will store all validations in the same database A list of all ava
53. 77 104 F Non condensing Up to 2000 m 6500 ft Up to 4600 m 14950 ft storage conditions Installation category Il pollution degree 2 G1361A Preparative Pump Performance Specifications Table 9 Performance Specification Agilent 1200 Series Preparative Pump Type Hydraulic system Settable flow range Flow precision Pressure range Compressibility compensation Recommended pH range Control and data evaluation Communications Safety and maintenance Specification Dual pistons in parallel 0 001 100 ml min lt 0 5 RSD 20 to 400 bar 5880 psi system pressure User selectable based on mobile phase compressibility 1 0 12 5 solvents with pH lt 2 3 should not contain acids which attack stainless steel Agilent ChemStation for LC Controller area network CAN RS 232 APG Remote ready start stop and shut down signals CAN DC OUT LAN optional Extensive diagnostics error detection and display through control module and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 9 Performance Specification Agilent 1200 Series Preparative Pump continued GLP features Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase w
54. 9 ages from 0 to 9 ChemStation ChemStation Software Revi was developed according to the quality process and software life cycle followed by the Life Sciences and Chemical Analysis divisions of Agilent Technologies Life cycle check point details were reviewed and approved by management The product was found to meet its functional and performance specifications and release criteria at release to shipment In order to fulfill the validation requirements of the users of this product according to current regulations and quality standards including but not limited to 21 CFR 210 Good Manufacturing Practice for Drugs 21 CFR 211 current Good Manufacturing Practice for finished pharmaceuticals 21 CFR 58 Good Laboratory Practice Agilent Technologies will make the source code and the documents referenced on page 2 of this declaration available to an authorized governmental or regulatory agency for inspection at its Pharmaceutical Solutions Unit Waldbronn Germany terms and conditions to be negotiated Agilent Technologies will maintain possession of all documents and their reproductions and may require a confidential disclosure agreement to be provided by those requiring access to these documents Date February 2006 4 SK re or lt whut Lul e si Di sr ae PHS CAS e Ge Money Clone PHS CAS Engineering manager Quality manager Product description Specifications Lifecycle Phase Transition Approvals
55. Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist U Setup the TCC O solvent inlet outlet column waste drain remote control if used CAN O O O 0 G1157A 58A 59A 60A 62A 63A Valves Pal Q Section NOT Applicable 1 SN FW 2 SN FW 3 SN FW Q Setup the Valves Q Setup the 1200 Series Valv O solvent inlet outlet O CAN O CAN DC In from other 1200 Module e g G1367B Autosampler G1364B C D Fraction Collector or G1361A Prep Pump G1383A Column Organizer Q Section NOT Applicable SN FW Q Setup the column organizer base plate and organizer plate rods traverses additional holders if used O O O O G1314B C VWD Q Section NOT Applicable SN FW Q Set up the detector O flow cell O solvent inlet outlet Issued Feb 2006 Rev 6 0 waste drain remote control if used analog output if used relay contacts if installed CAN O Agilent LAN see note Q Verify the operation of the detector O Oo 0 Example Only See your originals shipped with the product or handed over by the Customer Engineer CT Section NOT Applicable 1 SN FW 2 SN FW Q Set up the detector s O deuterium lamp if not installed solvent inlet outlet waste drain remote control if used analog output if used relay contacts if installed CAN Agilent LAWN see note Verify the operation of the detector lo ooo Lamp Pass Fail Intensity Alpha Deviation
56. Beta Deviation WL calibration G1321A FLD Q Section NOT Applicable Copyright 1995 Agilent Technologies WAD Product Support yee Agilent Technologies e SN FW Q Set up the detector O solvent inlet outlet O waste drain remote control if used O analog output if used SAN silent LAN see note the operation of the Ji Pass Fail Excitation Deviation coin 1 Emission Deviation G1362A RID Q Section NOT Applicable SN FW Q Set up the detector WARNING Make sure that all plugs are removed from the ports and the appropriate capillaries inlet outlet recycling are connected maximum backpressure of 5 bar for flow cell O solvent inlet outlet solvent recycle waste drain remote control if used analog output if used CAN Agilent LAWN see note O 0 0 0 0 O Verify the operation of the detector Diode Balance Value Page 3 of 6 Agilent 1200 Series Liquid Chromatograph yee Agilent Technologies 09 e Hardware and Software Installation Checklist G1364B C D Fraction Collector Q Section NOT Applicable 1 SN FW 2 SN FW 3 SN FW 4 SN FW Q Setup the fraction collector s solvent inlet ow waste drain remote control relay contacts CAN Agilent LAN O O O 0 Dr G1390A Universa UIB Q Section NOT A SN FW Example Only see your originals shipped with the product or handed over by the Customer Engi
57. ChemStation Declaration of System Validation ChemStation Installation Verification Report Customer contributed documents 4 Operational Qualification 00 Phase 00 PV Protocols Agilent ChemStation Verification Test Report Certificates showing tracebility of Standard Caffeine Kit Holmium Oxid Glass Filter Type Hoya HY 1 Customer contributed material Agilent 1200 Series Qualification Workbook Contents 5 Performance Qualification PQ Phase Preventive Maintenance Checklist Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist Agilent 1200 Series Liquid Chromatograph Scorp of Work Preventive Maintenance Agilent 1100 1200 Series LC MSD Quad Major Preventive Maintenance Checklist Agilent 1100 1200 Series LC MSD Quad Major Interim Preventive Maintenance Checklist System performance and noise Customer contributed material Agilent 1200 Series Qualification Workbook System Description This book is dedicated to the HPLC system below 2 Agilent Technologies Sten Manufacturer o SOS Module Model o l S E Serial Firmware Revision System o S Module Model o ______ Serial Firmware Revision System o YS Module Model o Serial Firmware Revision System o Module Model o Serial Firmware Revision System o YS Module Model o o Serial Firmware R
58. Control 2 Data Analysis 3 Report Layout 4 Verification OQ PV 5 Diagnosis 5 Sequence BATCH1 S v Show Top Toolbar v Show Status Toolbar Reprocessing Copy SHO Ta 4 R 30 100 ChemStore Review Client Vi ChemStation Scheduler Change access Level Database Logon 0 000 ml mi ATO Lock ChemStation privately v Sampling Diagram non privately System Diagram ChemStation Status Logbook gt Done sample runs 90 i Full Menu LC Parameters Dof3 so i Ino 5 00 pl I 70 Flow 0 000 m Figure 17 Instrument session lock base to unlock the session for example during shift changes figure 17 If a dialog is still open the application will automatically lock privately 29 ChemStation Plus Security Pack Data Integrity Automated Result Versioning and Data Reanalysis Data integrity The Security Pack maintains full data integrity by storing all results along with the raw and meta data in a relational database as shown in figure 18 Result revision management Daily work in the analytical labo ratory often requires sample reanalysis The ChemStation Plus Security Pack includes a result versioning that stores all recalcu lation results from one original_ injection as result versions I addition the application soft includes a tool that automati detects new results during th reanalysis process This appl tion controlled automated
59. Create a new MS Access database no yes Configure database Alias no yes Access the ChemStore ODBC spooler to resume interrupted data transfer yes yes Access to the selection list of available databases no yes Table 10 Tasks requiring membership in the Windows Administrators or Power Users group 21 Permission Windows Directory file Local directories storing relevant File path R chromatographic data are also Windows Administrators protected with Windows file and Users or Power Users directory permissions Table 11 hpchem chemstor W full full RWXD gives an overview of the Windows database permission rights on the data directories and files on the local hard disk The first item in brack hpchem chemstor WX full full RWXD ets displays the permission rights 9990 on the folder the second item displays the individual file hpchem chemstor none full permission rights Note Windows file secur give any access to directory for users have access rights even if the user has the files in the fold hputil00 exe Example Only see your originals shipped with the product or handed over by the Customer Engineer ChemStation P User management and ChemStation Plus Security Pack user access rights Security Pack provides a fully integrated user management that is independent of the Windows operating system The user management covers both the ChemStation Plus data acquisition and data analysis t
60. Customers should ensure that all necessary operating supplies consumables and usage depend such as paper pens solvents H grade water 2 propanol are av Analytical columns should be ri from the column compartment system should be flushed with E grade water and all samples ren from the autosampler A Custor Representative should be availa while performing the preventive maintenance procedure LC System Note Complete the PM Checklist in the order given Q Check for proper mounting and functionality of all leak sensors Q Wash deposits from each leak sensor PUMPS G1310A 11A 12A Pump Q 1 Record model number Example Only See your originals shipped with the product or handed over by the Customer Engineer a 3 Record model number O 3 Record serial number Q Ask Customers if they would like the module s firmware updated If firmware is to be updated the O 3 Result rt a ee Agilent Technologies Replace PTFE Frit gold seal and plastic cap in purge valve Replace the sieve gold seal and plastic cap in the outlet ball valve 2x for G1312A Open purge valve and attach restriction capillary to purge valve Prime applicable channel into a suitable container with IPA for 10 minutes For a Binary pump prime Channel A For a Binary pump with a solvent selection valve prime Channel A2 For a Quaternary pump prime Channel While purging begin tenance on the sampler or lal i
61. Hz 5 300 VA 200 W 4 55 C 41 131 F 40 to 70 C 4t0158 F lt 95 at25 40 C 77 104 F Up to 2000 m 6500 ft Up to 4600 m 14950 ft Installation Category Il Pollution Degree 2 For inddor use only Comments Wide ranging capability Maximum Maximum see User Manual Non condensing For storing the autosampler Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1329A Autosampler 900 ul metering head Performance Specifications Table 17 Performance Specifications Agilent 1200 standard autosampler G1329A Valid when standard 900 ul metering head installed Type Pressure GLP features Communications Safety features Injection range Replicate injections Precision Minimum sample volume Carryover Sample viscosity range Sample capacity Injection cycle time Agilent 1200 Series Qualification Workbook Specification Operating range 0 20 MPa 0 200 bar 0 2950 psi Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN GPIB IEEE 448 RS232C APG remote standard optional four external contact closures and BCD vial number output Leak detection and safe leak handling low voltages in maintenance areas error detection and display 0 1 900 ul in 0 1 pl increments recommended 1 ul increments Up to 1800 ul with multiple draw hardware modification required 1 99 from on
62. PAS CHUNG TIE GON Ol rina ea ee ue 24 Agilent ChemStation for GC 24 Agilent ChemStation for LC Systems 26 Agilent ChemStation for LC MSD Systems 30 Agilent ChemStation for A D 33 Additional Data Evaluation Modules 34 High Throughput Purification Software Module 37 Agilent ChemStore C S Database Client Software 37 Agilent ChemStation Plus Security Pack 38 NORME a iii aa 38 DOCUMENTA DO ernia ne a a ao 39 General Description The Agilent 32 Bit ChemStations for GC LC LC MSD CE and A D Systems are instrument control data acquisition and data evalua tion systems for e Agilent 6890N 6890 Plus and 6890A gas chromatographs e Agilent 6850 gas chromato graph e Agilent 5890 Series II and 4890D gas chromatographs e Agilent 1200 Series modi and systems for HPLC in ing the Agilent 1200 Serie LC MSD e Agilent 1100 Series modu and systems for HPLC in ing the Agilent 1100 Serie LC MSD e HP 1090 Series liquid chr matographs Lo e Agilent 35900E dual channe analog to digital interface and e Agilent capillary electrophore sis systems The software is designed to run on IBM compatible personal comput ers with a PCI interface under Microso
63. Pb lt 0 001 Loss on drying 105 C lt 0 5 Water 18 2 MO x cm The standards in this kit have been produced gravimetrically using ISO 9000 quality procedures Balances used are calibrated regulary against PTB Physikalisch Technische Bundesanstalt Federal Physical Technical Institute Braunschweig Germany traceable weight sets The standards have been analysed on a high performance UV VIS NIR spectrophotometer The spectrophotometer is regularly validated for accuracy and reproducibility of absorbance and wavelength as well as for linearity baseline drift stray light and spectral resolution power using the following testing materials Absorbance NIST SRM 1930 and double aperture method Wavelength NIST SRM 2034 emission lines of D Hg and Ar lamps Stray light NIST SRM 2032 Spectral resolution power Half width value of D2 emission lines for checking the effective optical bandwidth UV VIS Spectrum Caffeine in water concentration 125 ug ml 250 Wavelength Absorbance 1 6 205 nm maximum 1 4 245 nm minimum D p 273 nm maximum 2 0 6 Example Only Date of release See your originals shipped with the product sr or handed over by the A Expiration date Customer Engineer y Gernand manager 4 Operational Qualification 00 Phase Holmium Oxid Glass Filter Type Hoya HY 1 Agilent 1200 Series Qualification Workbook Declaration of Conformity We herewith inform you that the H
64. an Overall validation definition of progr and component co in the Method Vali software LI L 2 Checkpoint planning User level 3 Each checkpoint can use different calculation methods depending on the applied guidelines The checkpoint configuration step is either repeated for each checkpoint or it is copied from another component using drag and drop functionality Data acquisition the validation experiment 3 Experiment preparation data management and execution User level 3 This step consists of e Creation of new or update of existing ChemStore study for the analytical result data 46 e Automatic translation of the validation into one or more system generated ChemStation sequences based on the vali dation configuration and e Submission of the sequence s to the ChemStation for data acquisition After acquisition the validation report AN Tiata pomme ou crd sir 14 Example Only See your originals shipped with the product or handed over by the Customer Engineer CUILLPPIUUIULI VVIZLOAI LL Create validation template Method 5 Creating the method validation report User level 1 e After data completion the method validation report is compiled according to the report configuration in step 1 style and level of detail for example charts statistical details calculation formula Figure 34 again illustrates the steps 2d above All configuration ansfer steps are full
65. and sequence files will be installed at the time of service delivery by an authorised Agilent service provider Please contact you local Agilent Technologies representative for more details Agilent 1200 1100 Series Diagnostics The Agilent 1200 1100 Series of systems and modules for LC have an additional ChemStation diagno sis view The diagnosis view is designed to help users identify instrument malfunctions starting from a par ticular symptom A failure of a particular instrument verification test will automatically identify the appropriate symptom for the user or the user may select the symp tom interactively One or more possible causes is listed for each symptom Each possible cause is associated with a series of diagnostic measure limits and a series of ests Users observe the nts and carry out the er to confirm or dis ssible cause of the malfunction fied the cause of the malfunction may be using the repair proce on the Agilent 1200 1100 Series Maintenance and Repair CD ROM The repair proce dures include parts and materials breakdowns and clear animated step by step graphics or video with a sound track for each repair procedure The procedures are called directly from the Agilent ChemStation diagnostics view Agilent ChemStation for LC MSD Systems Instrument Control Data Acquisition and Data Evaluation with the Agilent ChemStation for LC MSD Systems G2710BA and the LC MSD Chem
66. by assigning access attributes to it when it is created Their design fits extremely well to modern database technology enabling systems to be developed to map analytical results or data directly to a relational database system 11 Software User Interface The Agilent ChemStation user interface consists of a navigation pane containing the ChemStation explorer plus navigation buttons and a navigation table Both frame the Views that group software functionality according to typical analytical tasks The ChemStation explorer provides means to select data or actions meaningful to the actual view e g loading a sequence or method Three stan dard views are present in all soft ware configurations e The Method and Run Control view for controlling and acqui ing data from the instrument e The Data Analysis view for The standard toolbar provides rapid access to the common sys tem specification information such as methods and sequences The Method and Run Control view additionally incorporates a system status bar a sample infor mation area that may be config ured for single runs or automated runs and a schematic instrument interface diagram for GC LC LC MSD CE and CE MSD configu rations The schematic instrument interface diagram uses hot spots to allow rapid access to instru ment parameters and an animated graphical overview of the status of r I reviewing eee Example Only e The Repor i desi
67. by fused silica capillaries Agilent 1200 Series Qualification Workbook Table 11 Design Qualification DQ Phase 2 Performance Specification Agilent 1200 Series Capillary Pump continued Control and data evaluation Analog output Communications Safety and maintenance GLP features Housing Agilent ChemStation for LC For pressure monitoring 2 mV bar one output Controller area network CAN GPIB RS 232C APG Remote ready start stop and shut down signals LAN optional Extensive diagnostics error detection and display through instant pilot and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase with user settable limits and feedback messages Electronic records of maintenance and errors All materials recyclable Physical Specifications Table 12 Physical Specifications Type Weight Dimensions height x weight x depth Line voltage Line frequency Power consumption Ambient operating temperature Ambient non operating temperature Specification Comments 17 kg 39 Ibs 180 x 345 x 435 mm 7 x 13 5 x 17 inches 100 120 or 220 240 VAC 10 Wide ranging capability 50 or 60 Hz 5 220 VA Maximum 4 to 55 C 41 to 131 F 40 to 70
68. cell path length and 50 bar 725 psi pressure maximum 80 nano 0 5 ul volume 10 mm cell path length and 50 bar 725 psi pressure maximum Comments The UV lamp is equipped with I D tag that holds lamp typical information See note on page 31 See note on page 31 See note on page 31 Self calibration with deuterium lines verification with holmium oxide filter Programmable in steps of 1 nm Programmable slit See Optimization Overview in the manual All flow cells are equipped with I D tags that hold cell typical information Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 27 Performance Specifications Agilent 1200 Series DAD and MWD continued Type Control and data evaluation Analog outputs Communications Specification Agilent ChemStation for LC 32 bit Recorder integrator 100 mV or 1 V output range 0 001 2 AU two outputs Controller area network CAN RS 232C APG Remote ready start stop and shut down signals LAN Comments Revision B 01 03 or above Safety and maintenance GLP features Housing Extensive diagnostics error detection and display through control module and ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas Early maintenance feedback EMF for continuous tracking of instrument usage in terms of lamp burn time wit
69. fluid 6040 0834 LC MS Technical Marketing 0 0 LEE O s Agilent Technologies Tighten the four bolts on the rough pump that hold the oil box to the pump body This will help eliminate rough pump oil leaks Replace mist filter element 1535 4970 Replace gas filters for nitrogen BHT 4 Replace inlet filter assembly Sum frit 0100 2051 Replace the rotor seal on the MS selection valve 0100 1855 Remove the desolvation assembly and then remove the glass capillary from s vation assembly Clean the illary Follow the ted capillary cleaning 2 1e platinum plated ends of capillary Note any physical r Wear the ion optics assembly from Jim manifold Disassemble ana Cican the ion optics assembly Follow the documented ion optics cleaning procedure Remove spray shield end plate and capillary cap Clean the parts Replace the canted coil spring 1460 2571 in the capillary cap Reinstall the spray shield end plate capillary and capillary cap Reinstall the ion optics assembly and desolvation assembly Pump the system down Record current vacuum readings O Rough Vacuum O High Vacuum Page 1 of 3 Agilent 1100 1200 Series LC MSD Quad Major Preventive Maintenance Checklist PP a Oe Agilent Technologies O Verify that all temperatures physical damage i e damaged tip pressures and gas flows reach tune O Perform general inspection of APCI or corrosion
70. for the novice user to become familar with the main tasks Validation assistant Method Validation Pack comes with an additional validation assistant that helps to configure and setup Method Validation Pack function ality An adminictrator can _eanficura Example Only See your originals shipped with the product or handed over by the Customer Engineer T _ PV LLL so LL ULLAL ULI so e Opening the last Validation per user VUULIIVAUMMUINCVGII The validation assistant guides the user through all configuration and planning steps in Method Validation Pack It can be used either to create a new validation or to add a new component to an existing validation It is accessible from the validation or help menu or via the context as described earlier Data completion wizard Some checkpoint information such as the concentrations for linearity can only be added after data acquisition It is not available during checkpoint planning Method Validation Pack therefore has an integrated data completion wizard As long as a checkpoint is not complete the related report cannot be generated and is flagged incomplete with an invalid data entry in the table of contents The Data Wizard points the user to all incomplete checkpoints prompting him for completion Double clicking it opens the data input grids Input fields with a dark background are locked and supposed to be automatically populated with data from the ChemStore
71. for appli cation users Overall the attempt to falsify or delete data requires the collaboration of the user and the database administrator that provides the direct database access Sufficient security constraints need to be imposed within the organisation to prevent any uncontrolled modifications Data storage By default the the database stores the following data e calculation results of the ChemStation e contents of the ChemStation data directories the d directories including the chromatographic raw data files e current method used for data acquisition and data a 7 e current sequence if al was run to acquire or data e sequence run and me logbooks e detector channel chrc grams as images acco the report configurati method and e apex spectra of all ide using a 3D detector e Optionally all peak performance parameters independent of the ChemStation method Protection of temporary data files The ChemStation uses a given data directory structure to store acquisition and result data The ChemStation Plus Security Pack also protects this data After com pletion of data acquisition and a first result calculation by default the data transfer is immediately initialized through the ChemStore spooler and the d directory with all its contents is deleted from the local hard disk these default settings can only be modified by a user with administrative rights in the database From then on the da
72. functions and orientation of the display including integration calibration select the display as overlaid or reporting annotation and signal separated and select scaling comparison toolsets Together factors with the navigation table they e The chromatogram display may form a fast and powerful means include graphical overlays of for data review and reprocessing instrument parameters depend The following key graphical opera ing on the capability of the con tions are possible figured instrument e Single or multi signal displays selectable nemdleadimmil chromatogi Cocina Example Only from differ ee ii i Renn see your origin als gram from shipped with the product e Graphical di or handed over by the is Customer Engineer e User defined annotations may Signal inve LI e be help visual CULL Pai LULL ULILIY VOULU UL IILIULI V INLUITLI UULU i e Graphical zoom and scrolling points in detector units functions e Export of time intensity digi e Adjustment of display attributes tized points to the Microsoft including selection of tick Windows clipboard marks baselines axes reten e Display of fraction results in tion times and compound graphics and table format names The user can also select 14 Data Analysis Integration The Chem32 integration algorithm used in the 32 Bit ChemStation is the second revision of a new gen eration integrator offering improved ruggedness reliability and ease of u
73. grouping functionality uses a simple drag and drop functionality to enable or disable grouping The user only drags the column header into the grouping section and receives a sorting of the complete audit trail according to the column entries As an example the audit trail should be arranged by user name The system displays all user name entries as parent nodes A simple click on the node expands the audit trail to now display all audit trail entries for the selected user as shown in figure 53 64 F3 Method Yalidation Pack User Ute Bober local login Demonstration Substance Audit Log E File Edit Validation Component Checkpoint Report View Security Utilities Window Help Degas St ef Change Password ge gt Short report Modem gt ah Program Auditing lt l I Demonstration Substance Archive Overview A Default Validation n header here for grouping shift click on head Validation nponent___ checkpoint action Signedby MI MD Main Peak 1 13 2004 5 05 33 PM Figure 52 n Da 7 ie i 5 5 20 Belogn 1 Saved Validation opened Upper 5 5 2015 DMS 1 Saved Validation saved None 5 5 2002 FSU AT AN i Admin 1 Saved Validation closed S ACI Stability long term 5 5 2002 9 51 08 AM CS Admin 1 Saved Validation opened Standard 5 5 2002 9 51 20 AM CS Admin 1 Sav
74. in a hierarchical list Entries can be selected to view all properties which are displayed on the right window pane of the DMS Additional information that is stored with each revision includes of entry e original path ose of entry manual ion automatic revision Plus Security Pack spei EEE ae See your originals MASATE Document managemi L aa a au L gt Method Validation Pacl sh IP p j d with th i P hi d M ct s normal checked out with a fully featured dc or handed over by the inalized management system D ai ni of user user domain and all data in a relational Cu stomer ng neer computer database For standalor all data are stored in a VDB file a database file that adheres to a common file format as used by MS Access The DMS is automatically started with Method Validation Pack and runs in the background It is used to store and maintain validation data by providing full versioning of validations and storage of all important related data such as configuration and planning information document attachments copies of reports and validation sequences that were generated for full traceability It stores all data under the validation name as the highest hierarchical element called document It is subdivided into four subsections as shown in figure 49 e VDB section for validation data base all data from planning configuration setup and analytical results 62 ame
75. items in the ChemStore menu figure 47 as well as new buttons in the graphical user interface The first button switches ChemStation into method validation mode and back to the standard mode The second button opens the sequence import dialog If method validation mode is enabled the user has access to the method validation sequence import menu The import window displays a list of all pending method validation sequences MVS files the user should have access to The list includes status information and user assignment of the MVS files In a client server installation the list of method validation sequences is accessible from any ChemStation in the cluster that has Method Validation Pack installed This means that validation planning and data acquistion do not need to be done on the same system Users can now select the MVS files they want to download from the list of pending files An MVS file has an assignment to one specific user or it has no user assignment and is thereby an all user job for all users with a valid logon an the appropriate access privileges to Method Validation Pack As soon as a user has loaded a pending validation sequence for execution in the ChemStation it is blocked for other users Be the sequence the additional sequen example calibrati runs or system SU Partially complete can be set to Fin the remaining acc deletes the file fr pending MVS files runs can be exect point in time by Suvit
76. line 2 vial 5 inj 1 17 40 51 06 08 00 Method Method completed 17 40 50 06 08 00 CP Macro Data not available Data Analysis not done 17 40 50 06 08 00 al Figure 26 sequence table Examp 0 n ly e any failure durir execution and see your originals SE e any modificatior parameters duri shipped with the product ESSI such as manuall tun time or handed over by the perno nega event e initialization of the ChemStore Customer Engineer i LI 4 Sia Method changes The method changes are stored with each current method version including a mandatory user comment for the change figure 27 The method audit trail stores e the time of change and the operator who performed the change e the current method revision in the database and e a mandatory comment of at least five characters each time the method was changed Sample audit trail The sample related audit trail shown in figure 28 documents e all changes and modifications on one sample report to file test separated signals i Sample Compound New Approval Pending Administrator 3 15 2002 16 42 31 3 15 2002 16 42 31 New Approval Pending Administrator 3 15 2002 16 42 31 3 15 2002 16 42 31 Mi New Approval Pending Administrator 3 15 2002 16 41 53 3 15 20021641 53 M 4 New Approval Pending Administrator 13 15 2002 16 41 53 3 15 2002 16 41 53 2 2 000
77. ly Ensure that all 1200 series 5 aa yo ur He g ma S perating a module on its side will defeat the leak detection syst chi ppe d with th e pro duct 1e module Recommended Stacking Coi or han ded over by the Customer Engineer single stack configuration The height of the stack doe The system does not include a G1330B thermostat module A multiple stack configuration must be used if The stack of 1200 modules is too high resulting in a safety problem The system includes a thermostatted sampler or fraction collector PLEASE NOTE The thermostatted version of all samplers and the fraction collector include the G1330B thermostat module The thermostat module must be placed directly under the sampler or the fraction collector to be thermostatted It is recommended that the thermostat module is positioned as the bottom module of the stack directly on the laboratory bench Any stack containing a G1330B thermostat module needs at least 25 cm 10 inches of space on either side to guarantee proper ventilation PLEASE NOTE Try to avoid stacking configurations that result in excessive volumes between sampler and column and between column and detector s to avoid potential problems related to excessive delay volume or peak broadening Please refer to figures 1 2 3 and 4 for recommended stacking configurations The figures just show a selected number of recommended configurations Other module setups might be possible but
78. nao ma i g Method Validation MV qualifies the process to make your work easier If the analytical method isn t validated then qualified instruments don t matter M ethod Validation is yet another critical component in the compliance process M ethods must be validated after their development and prior to routine use And if any parameter is changed signifi cantly the method must be validated again Agilent s M V products will ensure that processes meet the standards of such organizations as United States Pharmacopoeia USP and the International Conference on Harmonization ICH One such product is the M ethod Validation Pack available for the Agilent ChemStation Plus software package and is just one of many software solutions for all validation needs to mms ET ra ni Cerity Networked Data Systems Lab specific software for smoother workflow The Cerity NDS family provides lab specific software applications that model the way analysts work making every step of the lab s workflow more efficient For regulat ed environments the Cerity NDS for Pharmaceutical QA QC provides a secure data management system where procedures must be followed according to compliance requirements such as 21 CFR Part 11 Version control inherent data integrity and security and an automatic fully traceable audit trail ensure no records can be overwritten Agilent can train you and your s
79. nominal value lies within the range of confidence of an analytical result The Wilcoxon test checks whether the distribution of values nf nne measiirinn rw is svmmetrical arniind a nominal x Planning dialog for checkpoint Accuracy content It is suitable for analytical methods which consist of weighing diluting and measuring steps For the recovery method linearity must be given for a number of samples with different content A nominal value for the variation coefficient VC can be entered for method comparison and for accuracy by recovery Planning data e Determination method e Comparison with nominal value y for the t test e Method compa joined samples sets determine different meth e Method compa validated meth to ICH e Standard addit e Extended spik e Recovery e Accuracy by re es according to ICH e Other data e Number of samples e Y units e Multiple injections possible Output settings for calculations e General Result t Test e Joined samples e Difference of value pairs e Mean value and standard deviation of differences e Nominal value comparison e Result of Wilcoxon test additional for nominal value comparison e Extended spiking method e Test quantity for a and b e Threshold quantity t division e Standard additional method e Result F test e Result t test e Recovery e Standard deviation for a b e Residual standard deviation e Method standard deviation e Test quantit
80. of significance should be applied for the t values for the t test as part of the selectivity checkpoint default is 5 two sided In addition the configuration task defines overall calculations that are common for all checkpoints These include outlier tests trend test homogeneity tests and systematic error detection Other settings allow specifying the minimum sample size for each test handling of zero as input value and handling of missing values Properties of validation Demonstration Substance C Program Files Salent Technologies Method Validation Pack Demo y Components Mare Path Main Peak Impiurity Impurity E Total imps Unknown Imparte RAT 2 62 Identification 1 Impurities Quantitative Impurities Quantitative 2 Impurities Quantitative 3 Impurities Limit 1 Impurities Lirit 2 Specific Tests 1 Example Only See your originals shipped with the product or handed over by the Customer Engineer For non Part 11 validations development validation the user may also specify the audit level in the configuration Output settings The method validation output settings define the output format and content of the validation report For each checkpoint the extent of statistical information contained in the report can be configured separately For details on the checkpoint content please see the checkpoint section lateron Further output settings define the decimal
81. of water with no column Setup a Support Provider Signature Use the DETECTOR conditions specified in method OQGRAD M Q Prime system with Cusi x mobile phase Note AEREO ENO Example Only see your originals shipped with the product or handed over by the Customer Engineer Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 5 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist yee Agilent Technologies 09 e Parts Requirements Please Note Any parts not included in the parts lists given below are not part of the recommended Preventive Maintenance Procedure nor are they included in the price of this service If a system has a special setup configuration that requires the use of additional or special parts for the instrument service then these parts must be ordered separately and billed as a repair If a customer demands additional service that is not listed in the procedures described above to be performed at his her ee then the additional service must be orceree separately and billed as a repair as well as na G1310A 11A 12 Example Only See your originals shipped with the product This maintenance pr G1310A 11A Isocr or handed over by the s of 2x Seals F Re Valve Assen Customer Engineer 1x PFTE Frit __ A 1x Outlet Gold seal 5001 3707 1x Outlet Cap 5042 1346 Outlet Ball Valve Assembly 1x Outlet Gold seal 5001 37
82. on predefined templates The templates include e Complete range all check points will be selected e Trace method selecting preci sion calibration function and limit of detection quantification e Trace method with demand above plus lab capability e Non trace method precision only and e Non trace method with demand above plus lab capability Each component typically includes one or multiple check points from the following list Precision used to monitor random errors Robustness Ruggedness Lab capability mainly used in non pharmaceutical applications Calibration function Limit of detection quantification Accuracy Selectivity Ring experiment used to com pare results among multiple lab oratories Linearity The checkpoint configuration will typically depend or the eamnaund type and hardly an requires execution points The system requires running th configuration for e individually Level 3 Checkpo Each checkpoint m ured The configuri the test and calculation methods data sources and data types for x and y values e g for linearity x value is amount in mg mL and the y value is peak height A typi cal planning dialog in this case for accuracy is shown in figure 37 The following sections are configurable for all checkpoints Headers These data sections will show the default data if configured in the validation properties and allow individual data entry for each header
83. originals shipped with the product or handed over by the Customer Engineer accordingly E Result data entry and statistical calculations After completion of the analytical experiments the results can be uploaded from the ChemStore database into Method Validation Pack The upload from ChemStore is an automated direct database data access invoked by the user The transfer is executed as defined in the planning of the validation experiments The data wizard helps to find and complete data sections that require manual entries The analytical results are contained in the ChemStore data Study Columns Rows Multiple Injections ro F mo Load study Run Data Wizard Checkpoints to be data shared with Reporting Overall report Generate Revision t Expor IK Cancel is e whereas the validation results contained in Method Validation k Traceability of results is achieved with unique run IDs in ChemStore for each result version The ChemStore run IDs are also transferred and displayed along with the analytical results in the Method Validation Pack When all result data is imported the validation report can be printed This report displays all data related to the validation as defined in the top level validation configuration This includes the components their planning and result data as well as the calculation results statistical data and conclusions for example outlie
84. plot is typical ly used during method develop ment to explore the sample s response at different UV visible wavelengths in order to determine the optimal detection wavelengths and bandwidths through experi mentation with the integration and quantification processes Users can define the contour color schemes and retention time and wavelength ranges for display Three Dimensional Plot Example Only see your originals e Quick view mode alli to view and compari and signals by movit hair over the area of tour map Spectra ar are continuously ext updated in the displ The extracted spectra and sig nals may be frozen in the dis play areas for comparison pur poses e Zoom mode allows users to zoom into areas of interest on the iso absorbance map e Signals mode allows users to extract a particular signal with a graphically determined band width into the chromatograph ic window for routine data pro cessing such as integration and quantification e Spectral mode allows users to extract spectra into the spectral window for further processing shipped with the product or handed over by the Customer Engineer VLLLLAULYIET UL LILLO ULOPVIGdy LO LIVU restricted in any dimension e The plot may be printed e The color scheme used in the plot may be selected from a number of choices Spectral Libraries Spectral libraries allow users to positively identify compounds by comparing the spectra of
85. precision for the result data shown in the report as well as graphic settings text elements and whether or not to document the configuration values in the report or include audit trail information Validation type C Development e 21 CFR pat 11 Configuration Output settings Default header data External documents Store method au Cancel e ap and configuration For text elements the output settings define e the report title page e an additional general report comment page e the report header e additional footer text and e default comments for validation planning and validation configuration In addition the text configuration defines the checkpoint table head ers Each checkpoint can have up to ten freely configurable header data items with different user defined content The header infor mation is used to describe general validation information that is necessary to uniquely identify and characterize the method validation experiment Examples for useful 47 table header are the product name the analytical equipment QS or internal ID number test method and others Default entries for the header data can be defined when selecting the default header data button in the validation properties Figure 36 shows table headers and default heac o data r Headers __ Wonderdrug WDG_rev 4 1 ion run number HPLC with MSD ABX_230666 Agilent 1100 series System
86. size limit is reached If a larger single database is required Agilent recommends that the client server version of the product be purchased The client server database uses Oracle which allows for a much larger database Table 9 gives some data on the time required for down loading data from the standalone database into the active memory of the client The time mainly depends on the size of the stand alone database the number of runs marked for download and 25 the performance charactistics of the computer All runs were stored with raw data methods sequences and all result versions The PC used for the test was below the recommended configuration Kayak PHI 450 MHz 128 MB and no data acquisition running in the background Database Size No of peaks No of runs 93986 2137 240 192048 4642 410 445826 22621 968 1048472 36710 2203 Table 9 No of runs loaded from database Time s 100 17 100 17 100 13 683 76 100 13 683 59 Run download time depending on the number of runs selected for download and the database size Example Only see your originals Working with Result managem The ChemStation Pack is designed t _ ChemStation data in a relational database by transferring it as a post data analysis spooling job to the database Depending on the laboratory workflow the data analysis can also be separated from the acquisition In this case only raw and meta data are automatically spooled to the
87. slices Peak threshold up downslope Timetable combination of time intervals and peak and Manual trigger supported only with G1323B Control Module Agilent 1200 Series DAD MWD detectors G1315A B C G1365 A B C the Agilent 1200 Series fluorescence detector and the Agilent G1946C D G1956A B LC MSD are fully supported other detectors can be used but are not supported for fraction collection operating modes Discrete fractions default mode for all vessels The flow is diverted to waste while moving from one vessel position to the next vessel position Continuous flow optional available only when using well plates It is possible to move from one well plate position to the next one without diverting the flow into the well plate to waste Fraction capacities 4 x well plates full tray MTP for use with deep well plates only and trays 2 x well plates std tray MTP for use with deep well plates only 10 x 2 ml vials 1 half tray 100 x 2 ml in std tray 1 half tray 3x40x2mlinhalf tray 3 x 15 x 6 ml in half tray Full tray with 40 test tubes 30 mm OD max height 100 mm 45 ml tube Full tray with 60 test tubes 25 mm OD max height 100 mm 25 ml tube Full tray with 126 test tubes 16 mm OD max height 100 mm 12 ml tube Full tray with 215 test tubes 12 mm OD max height 100 mm 7 ml tube Installed trays are automatically detected and identified For the with uncapped vials tests tubes and well plates
88. standoffs with lint free or handed over by the italien methanol Reinstall m ressures and gas flows reach tune i dala Customer Engineer rene an spray chamber includi F with a lint free cloth w th methanol LI Verity that all temperatures U Check manually that you have tune pressures and gas flows reach tune peaks in positive and negative mode file set points Generate tune reports in positive and Q Replace and properly adjust nebulizer ti de needle G1946 60136 negative mode Q Check manually that you have tune Q Verify that all temperatures peaks in positive and negative mode Q Add results to PM documentation pressures and gas flows reach tune Generate tune reports in positive and file set points negative mode G1978A Multimode Source Q Check manually that you have tune l peaks in positive and negative mode Q Add results to PM documentation Perform source maintenance on currently Generate tune reports in positive and installed source only negative mode Q Record serial number G1971A APPI Source Q Add results to PM documentation Perform source maintenance on currently installed source only QO Perform general inspection O Inspect corona needle holder for oxidation or physical damage i e springs on needle holder G1947A APCI Source Q Record serial number Perform source maintenance on currently installed source only Q Perform general inspection of APPI O Inspect needle receptacle for Q Record seri
89. study Input fields with normal background color require manual entries tion structure ition Plus Method m Pack translates the n requirements into a gt d workflow following a approach to analytical validation It requires the horoughly configure and lidation before executing Aa experiment By design it forces the user to separate method validation testing into three steps e planning and design e test execution run samples and e result calculation based on the experimental result data All of these tasks are managed within ChemStation Plus All ChemStation Plus modules support data security data integrity and audit trails for comprehensive support of FDA s requirements for electronic records and electronic signatures 21 CFR Part 11 The combination of audit trails in all ChemStation Plus modules with the advanced data security features built into the relational database offers full traceability and complete documentation of all steps during the method validation experiments 45 Method Validation Pack hierarchy The Method Validation Pack soft ware structure is strictly hierarchical divided into five levels These levels also correspond to user access levels The list below outlines the step by step execution of the method validation experiments with the hierarchical structure and the user access levels r Before acquisition validation template 1 Setup and config User levels 5
90. the amount x is 1 x x a where a is the smallest amount of the cali brated compound prepared in the calibration standards If the origin is included it is assigned the mean of the weightings of the other cali bration points Linear Resp A calibration point with the response y has the weighting 1 y normalized to the smallest response so that the largest weight factor is 1 Normalization is done by multiply ing the weight with the smallest response For example the weight of a calibration point with the amount y is 1 y x b wher the response correspondi smallest amount of the cz compound prepared in th tion standards If the orig included it is assigned the the weightings of the othe bration points Quadratic Amnt A tion point with the amour the weighting 1 x2 normauzewto the smallest amount so that the largest weight factor is 1 Normalization is done by multiply ing the weight with the smallest amount For example the weight of a calibration point with the amount x is 1 x2 x a2 where a is the smallest amount of the cali brated compound prepared in the calibration standards Quadratic Resp A calibra tion point with the response y has the weighting 1 y2 normalized to the smallest response so that the largest weight factor is 1 Normalization is done by multiply ing the weight with the smallest response For example the weight of a calibration point with the response y is 1 y2 x b
91. to be determined The quantitation limit is higher than the detection limit The relative error of results is requied to calculate the quantitation limit Both the d etection limit and the quantitation limit can be calculated by the standard deviation of blank values blank value method or the residual standard deviation of regression data calibration curve method Only one of the two methods may be suitable for practical purposes Both methods however are almost equal with respect to the detection limit The Example Only See your originals shipped with the product or handed over by the Customer Engineer Calibration function m Headers According to ICH Run number HPLC fantasy Agielnt 1100 for serial numbers see checkpoint header no comment m Planning data Number of levels 6 Unit of values sid Curve fit display fi 1 linear 2 quadratic 3 cubic Multiple determination Multiple injection Number per value Number per value OK Cancel TT Multiple determination Comment Figure 42 ChemStation Plus Method Validation Pack Planning a calculation of LOD and LOQ based on the standard deviation of the signal and the calibration curve slope This is referred to as according to ICH in the planning dialog Finally LOD and LOQ can be determined by visual inspection based on the signal to noise ratio In
92. unit Ss ades ChemStation Plus Method Validation Pack Planning i late night wake up drug Data type Height e Lower specification batch ce A Test criteri According to ICH DE e Upp er sp e cifi C ation Dimension rante Additional header info Header line 1 v e Calculation of Xb where Xb is om cm ve i Agielnt 1100 eader line 2 xl the reference value exp ected for serial numbers see checkpoint header Header line 3 analytical result value no comment Hederis TT e Multiple injections possible E III Boe x Determination method ighti Junwei Lineari Output settings for calculations dalia me di sant M Proportionality Nominal value d o e Linearity calculates a linear regression using the least No output settings can be Niveau Spec limit g fo square error method for the model y a bx With the 1 A n optional test on proportionality is checked whether a configured by the user For lab Number of additional values D one peltf celibvatlie awali Foris Wis vevleed at a 1l1 1l1 given concentration by means of real multiple capability the lab capability index Number of levels E determinations how the deviation influences the Cm and lab performance index Y Units Fa determination ofthe content by a one point calibration Pm are determined as well as the Mialiple detenrination corrected values Cmk and Pmk Multiple injection Number per value M Number per value OK Cancel TT Multiple determina
93. work with print ers that are compatible with the operating system The software operates with any Microsoft Windows compatible printer capable of interpreting an escape code language e g PCL or page description language e g PostScript The printer may be directly connected to the comput er through a parallel or serial interface or connected through a Local Area Network Serial port printers are supported by the operating system but may exhibit speed performance limitations Networked printers must be shared by a network server run ning a network protocol support ed by the Microsoft operating system Recommended black and white printers are the HP LaserJet family using PCL 5e or 6 For lower performance applications it is possible to use the HP DeskJet family Please note that the HP DeskJet printer family is not rec ommended for high throughput applications LAN Transmission Rates Traffic on the LAN from each instrument is approximately 100KB per second for a 2D instru ment at maximum data rate Recommended color printers are the HP LaserJet 2500TN OfficeJet Pro K550DTWN or an HP DeskJet family printer Agilent Technologies has not test ed all printer and printer driver combinations that are supported in the Windows environment Print performance and results may vary on other manufacturer s printers and appropriate drivers Please note that host based print ers e g GDI or PPA printers impose more pro
94. 0 3 Loaded as part of Approval Pending Administrator 3 15 2002 16 41 45 1315 2002 1621 55 13 i 3 0000 3 Added to Batch Approval Pending Administrator 3 New Approval Pending Administrator 3 TNew Approval Pending Administrator Btart of compare 3 15 2002 5 37 46 PM 2 New Approval Pending operator Dperater admin E L L ee Datafile 005 0102 D 2 New Approval Pending operator2 1 New Approval Pending operator 1 New Approval Pending operator Compare of Signal DAD1 A Sig 254 4 Ref 550 100 Area Difference in Peak 1 02 min Last value was 0 7 Amount Difference in Compound 1 02 min Last value was 0 092591 Current value is 0 091928 Comment for selected entry Modified data have been set as reference ChemStore is updated Baseline drawn manually Automatic transfer from batch after detecting different results Modified Custom held ve Archiv tal List of integration events history for signal DAD1 A Sig 254 4 Ref 550 100 Event No 1 Time Start 0 942071 min Abs Start 0 116093 mAU offset from chromatogram at begin peak Time End 1 191617 min Abs End 0 000818 m U offset from chromatogram at end peak Command Draw Baseline Man Integ Details Figure 28 Audit trail table with manual change documentation in the comment field 30 manual interactive changes are e change of custom field values e manual reintegration during reanalysis e approval reje
95. 0 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption 220 VA Maximum Ambient operating temperature 4 55 K 41 131 F Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 6 Physical Specifications continued Non operating altitude Up to 4600 m 14950 ft For storing the binary pump Safety standards IEC CSA UL Installation Category II Pollution Degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1312B Binary Pump SL Performance Specifications Table 7 Performance Specifications of the Agilent 1200 Series Binary Pump SL Type Specification Comments Hydraulic system Two dual piston in series pumps with proprietary servo controlled variable stroke drive floating piston design and active inlet valve Setable flow range Setpoints 0 001 5 mL min in 0 001 mL min increments Flow range 0 05 5 0 mL min Flow precision 0 07 RSD or 0 02 min SD whatever based on retention time at is greater constant room temperature Flow accuracy 1 or 10 pL min what ever is measured with water greater Pressure Operating range 0 600 bar 0 7800 psi up to 5 ml min Pressure pulsation Standard delay volume configuration at 1 mL min water lt 2 amplit
96. 07 1x Outlet Cap 5042 1346 Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 6 of 11 Agilent 1200 Series li Agilent Technologies Liquid Chromatograph Preventive Maintenance Checklist G1312A Binary Pump kit G1312 68730 consists of 4x Seals 2x 5063 6589 Standard Pack of 2 Purge Valve Assembly 1x PFTE Frit 01018 22707 pack of 5 1x Outlet Gold seal 5001 3707 1x Outlet Cap 5042 1346 Outlet Ball Valve Assembly 2x Outlet Gold seal 5001 3707 2x Outlet Cap 5042 1346 2x Sieve 5063 6505 pack of 10 needed for binary pump only GISIOASLIA IZA Is Exam ple Only WASH G1310 68731 consists of Le 2x Wash Seal See your originals 2x Wash Seal Gasket been shipped with the product Seal wash items are ni or handed over by the The kit above 1s neede Customer Engineer G1361A Prepar This maintenance procedure requires the following consumables for each pump the parts are all included in the G1361 68710 Prep Pump PM kit Pump Head Assembly 4x Prep Flange Seals 5022 2188 Multi Assy 1x Filter cup 3150 0942 Ix SST Filter Assy 5022 2192 Seal wash pump 1x Cartridge 5042 8507 1x Tubing 0890 1764 2x Fittings 5042 6422 Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist x Agilent Technologies G1376A Capillary Pump or G2226A
97. 14 The administrator may de which approval level is _ ropriate to initiate the LIMS transfer In addition the LIMS can acknowledge data that was successfully transferred to LIMS to exclude it from future updates Workflow The workflow can be divided into five sequential activities shown below 1 The sample list is generated by the LIMS system in an XML format 2 It is imported by the Agilent ChemStation and translated into a ChemStation sequence 3 Samples are analyzed results are calculated and stored in the ChemStore C S relational Oracle database 4 Information typically required by LIMS systems are instantly made accessible in the ChemStore C S database tied to the existence of the LIMS ID 5 If enabled on the system or for a specific study a LIMS notification is triggered upon the approval of data as configured in the approval configuration console 6 A program from the LIMS systems can scan a table in the database for a specific update flag to see if any new records are available for prc and can amend the that it is not scanne subsequent scans Default approval configuration Runs will be locked n HEYET on first level approval on third level approval Lime notification The Lims export will start never after first level approval after second level approval after third level approval Example Only see your originals shipped with the product o
98. 2 where b is the response corresponding to the smallest amount of the cali brated compound prepared in the calibration standards Calibrations A calibration point is weighted according to the number of recalibrations of the point No normalization is done The origin of the calibration curve may be specified as Example Only see your originals shipped with the product or handed over by the Customer Engineer Compound identification may be refined by defining individual retention time windows parame ter limits and qualifier peaks Qualifier peaks are usually the same compound detected on a dif ferent signal with a predictable response ratio They are used as a further check on peak identifica tion rather than just relying on retention times Each calibrated compound may have individual absolute limits for the amount peak area peak height symmetry efficiency in plates resolution and k Results lying outside any defined limits are indicated on the appropriate analysis report They may be used in conjunction with the control samples that can be defined as part of the automation setup to verify the performance of the sys tem running automatically The ChemStation can calibrate methods with up to 1000 peaks and 2000 calibration points This means for example with 1000 cal ibrated peaks only two calibration levels may be defined for each peak With fewer peaks more lev els may be defined in proport
99. 3 No comment Figure 36 Default headers grey and header data Table headers can only be changed or overwritten by changing the complete validation configuration while the default header data can be overwritten for every checkpoint The graphics section defines the checkpoints that will have graphic result visualization in the final report Default checkpoint header data This section defines the header data section of the checkpoint report as defined in the output set tings It provides a single entry point for common data for all checkpoints e g the method name or an internal code for the tests All data that are entered as default reporting header data are copied to all checkpoint headers The default checkpoint header data can be manually modified for each 48 individual checkpoint if the actual information are different from the preconfigured header data Using default header data speeds up the checkpoint configuration as it allows skipping multiple data entries for the checkpoint headers One example that might outline tha ucaaa af dafault data far tha Example Only See your originals shipped with the product or handed over by the Customer Engineer ULLI V UV UAL NILO VIN WILL U A VI ULI ruggedness checkpoint the default header data for the instrument will be manually overwritten for all other checkpoints the default header data are copied and do not need a manual e
100. 6 16 Procaine decay 10 6 94 2 18 25 PI lsocratic Std 1 4 19 94 7 aj 52 24 r Used method S i None 4 Method BATCH M 2422 99 9 55 59 AM User Operator Al users f User support be operator data review the sample centric Sample view and the compound centric Compound view Both views are further subdivided into a tabular display with or without chromatograms and or spectra and a chart display for plotting sample or compound related data The task flow of Agilent ChemStore C S is designed to support the laboratory s workflow and can be outlined as follows 1 Select the database that contains the data you want to work with 2 Extract the set of results you data The ChemStore C S review client provides two user interfaces for will work with This is done via a database query and the results become the current set of data 5 Perform any of the following tasks in any order e Review the results by sample or by compound While reviewing the results you may switch between any of several different data presentations for example a table a chart or plots of the chromatograms and or spectra In addition you may specify additional statistical computations to be done on the results and included in the tabular or graphical presenta tions e Generate a report or data in the set of dat set of report templal used and you may c
101. 82A G1376A Capillary Pump G1379B Micro Degasser G2225A G2226A Nano pump G1379B Micro Degasser Q Section NOT Applicable Page 1 of 6 Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist 1 SN FW 2 SN FW Q Setup the pump solvent inlet outlet waste drain remote control if used relay contacts 1f installed CAN Agilent LAN see note set up the degasser solvent inlet outlet priming each channel with Isopropanol from solvent bottle to pump inlet O Priming the pump O prepare solvents turn on a purge purge mobile ph monitor the pres OO0O000000 0 O O O 0 G1361A Prep Pump Q Section NOT Appli 1 SN FW 2 SN FW Q Setup the pump s solvent inlet outlet waste drain remote control if used relay contacts 1f installed seal wash tubing CAN Agilent LAN see note O Oo ooo 0 Q Priming a prep pump O Prime each pump individually O Use the syringe adapter tubing and connect to the waste outlet of the pump s EMPV O Turn ON the pump and Issued Feb 2006 Rev 6 0 electronically switch the EMPV to waste O Manually suck the solvent into and trough the pump O Pump at least 0 5 liter of IPA through the pump G1328B Manual Injector or 5065 9922 Prep Manual Injector Q Section NOT Applicable SN FW Q Setup the injector O start stop cable to pump O base plate amp mounting pole O position valve O inlet outlet connected Example O
102. 90001 Valid June 2006 Certificate Pump Specifications G1310A Isocratic Pump G1311A Quaternary Pump G1312A Binary Pump G1312B Binary Pump SL G1361A Preparative Pump G1376A Capillary Pump G2226A Nano Pump Injection Systems Specifications G1329A Autosampler 100 ul metering head G1329A Autosampler 900 pl metering head G2260A Preparative Autosampler G136 7B High Performance Autosampler and G136 C High Performance Autosampler SL G1377A Micro Well plate Sampler Detectors Specifications G1314B Variable Wavelenght Detector and G1314C Variable Wavelenght Detector SL G1315B Diode Array Detector G1365B Multible Wavelength Detector Agilent 1200 Series Qualification Workbook Contents G1315C Diode Array Detector SL G1365C Multible Wavelength Detector SL G1362A Refractive Index Detector Fraction Collectors Specifications G1364B Fraction Collector preparative scale G1364C ANALYTICAL SCALE Fraction Collector G1364D Micro Collector Spotter Valves Specifications G1157A Agilent 1200 Series 2 position 10 port valve G1158A Agilent 1200 Series 2 position 6 port valve G1159A Agilent 1200 Series 6 position selection valve G1160A Agilent 1200 Series 12 position 13 port selection valve G1162A Agilent 1200 Series 2 position 6 port micro valve G1163A Agilent 1200 Series 2 position 10 port micro valve Miscellaneous Specifications G1322A Vacuum Degasser G1379B Micro Vacuum Degasser G1316A Thermostatted Column Compartment G1316B T
103. 98 for power cord configurations supply Example Only a see your originals a shipped with the product or handed over by the Customer Engineer 98 0 or better N gt gas Her or gt liquid N Dewar Balance of impurity should consist of oxygen and or argon Gas must be hydrocarbon free lt 0 1 ppm Outlet Pressure 80 100 psi A 1 4 Swagelok outlet male fitting is required to connect the LC MSD Volume Up to 15 liters min Laboratory Supply Requirements Mobile Phases Water Methanol Isopropanol Acetonitrile O Purity HPLC grade or better Buffers Ammonium Formate Acids Acetic or Formic Acid Purity Ammonium formate 97 or better Acetic acid 99 7 or better Formic acid 96 or better Methanol water required for G1956B installation Organic water required for G1956A installation Required for G1956B installation Optional for G1956A installation Issued Feb 2006 Rev 2 0 Copyright 2005 Agilent Technologies LC MS Technical Marketing Page 2 of 3 Agilent 1200 Series LC MSD G1956A B G2908AA G2908BA G3218AA G3218BA 2 7 Agilent Technologies Site Preparation Specification Exhaust Venting Requirements Tick Boxes Capacity Up to 15 liters min total Connections Separate 1 2 hose barbs required for rough pump and ion source ES APCI APPI or QI MM A 20ft length of 1 2 inchi d Tygon tubing is included for venting source exhaust drain bottle and rough pump
104. AE Agilent Technologies According to ISO IEC Guide 22 and CEN CENELEC EN 45014 Manufacturer s Name Agilent Technologies International sarl Manufacturer s Address Rue de la Gare 29 Supplier s Address CH 1110 Morges Switzerland Declares under sole responsibility that the product as originally delivered Product Name 1200 Series Isocratic Pump 1200 Series Quaternary Pump Model Number G1310A G1311A Product Options This declaration covers all options of the above products complies with the essential requirements of the following applicable European Directives and carries the CE marking accordingly Low Voltage Directive 73 23 EEC amended by 93 68 EEC EMC Directive 89 336 EEC amended by 93 68 EEC and conforms with the following product standards EMC Standard Limit IEC 61326 1 1997 A1 1998 EN 61326 1 1997 A1 1998 CISPR 11 1997 EN 55011 1998 Group 1 Class B di CISPR 11 1997 EN 55011 1998 IEC 61000 3 2 1998 EN61000 3 2 1995 A1 2 1998 Graup T as A IEC 61000 3 3 1994 EN61000 3 3 1995 IEC 61000 4 2 1999 EN 61000 4 2 1995 A1 1998 4kV CD 8kV AD IEC 61000 4 3 1999 EN 61000 4 3 1996 A1 1998 3 V m 80 1000 MHz IEC 61000 4 4 1995 EN 61000 4 4 1995 0 5kV signal lines 1kV power lines IEC 61000 4 5 1995 EN 61000 4 5 1995 0 5 kV line line 1 kV line ground IEC 61000 4 6 1996 EN 61000 4 6 1996 3V 0 15 80 MHz IEC 61000 4 11 1994 EN 61000 4 11 1994 cycle 20ms 100 Australia New Zealand AS NZS 2064 1
105. Agilent ChemStation Plus Method Validation Pack The UV Vis as well as GC MS ChemStation offer separate solutions for 21 CFR Part 11 Please refer to the specifications of the UV ChemStation Security Pack and the MSD Security ChemStation included in publication number 5980 0337E 24 and 5989 0848EN respectively The ChemStation Plus Security Pack is available as a standalone solution or in a fully integrated client server network connected to the ChemStore C S server Oracle database It provides full support of 21 CFR Part 11 by offering advanced data security data integrity and full change documentation in audit trails Specifications of the ChemStore C S database module are available in the ChemStore C S section of this document Example Only See your originals shipped with the product or handed over by the Customer Engineer to the application A user with administrative priviledges can assign appropriate user permis sions to other users within the ChemStation Plus software The ChemStation Plus Security Pack software allows to match user tasks in the laboratory with user roles in the software It modifies the ChemStation operator rights allowing to routinely operate the ChemStation application in the operator mode For proper use and to achieve the best data security capabilities all users except those with administrative functions should utilize the ChemStation operator mode To achieve data integrit
106. Agilent ChemStations and or Agilent ChemStore C S review clients It provides enhanced data security and data integrity distributed processing as well as the ability to store raw data methods and sequence files within the database This configuration reflects best the regulatory needs for electronic records and ensures full data integrity and traceability Based on standard database features Agilent ChemStore C S offers functionality which focuses on the user s needs for fast secure and traceable handling of chro matographic data e User defined or automated transfer of selected data from the Agilent ChemStation into the Agilent ChemStoi TT base e Define edit and man studies as the unde storage format e Manage or restrict de in studies by assignir access only to authol e Create database quer graphically without t any knowledge of th guage e Review entire sets of data across instruments and studies that several sequences in a fast and easy manner e Create additional filters and selection criteria to produce adequate subsets of the study in order to best sort the data and optimize the performance e Complete audit traceability by individual log ins and complete documentation within the data base including authorization failures e Security check of all files that have been transferred over the network from the ChemStation application to the ChemStore database application and back Whene
107. C 32 131 F Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at25 40 C 77 104 F Non condensing Operating altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the detector Safety standards IEC CSA UL Installation category II pollution EN degree 2 For indoor use only Agilent 1200 Series Qualification Workbook Design Qualification DO Phase G1315C Diode Array Detector SL G1365C Multible Wavelength Detector SL Performance Specifications Table 27 Performance Specifications Agilent 1200 Series DAD and MWD Type Detection type Light source Wavelength range Short term noise ASTM Single and Multi Wavelength Drift Linear absorbance range Wavelength accuracy Wavelength bunching Slit width Diode width Flow cells Specification 1024 element photodiode array Deuterium and tungsten lamps 190 950 nm 0 8 x 10 AU at 254 and 750 nm 0 9 x 10 AU hr at 254 nm gt 2 AU upper limit 1nm 1 400 nm 1 2 4 8 16nm lt 1nm Standard 13 ul volume 10 mm cell path length and 120 bar 1760 psi pressure maximum Semi Micro 5 pl volume 6 mm cell path length and 120 bar 1760 psi pressure maximum Micro 2 pl volume 3 mm cell path length and 120 bar 1760 psi pressure maximum High pressure 1 7 ul volume 6 mm cell path length and 400 bar 5880 psi pressure maximum 500 nano 0 5 ul volume 10 mm
108. Calib Peak Diethylphthalate at ExpRT 1 6219 not found Example Only See your originals shipped with the product or handed over by the Customer Engineer ChemStore C S Administrator hpcs gin peak id peak rual run revision a File View Options Review Report Administration Method Validation Help lt untitled gt No statistics v Sequence Summary Report amp R ai Sample Compound Audit trail EI Modified by Modified at TR New Approval Pending Administrator 3 15 2002 16 42 31 3 15 2002 16 42 31 New Approval Pending Administrator 3 15 2002 16 42 31 3 15 2002 16 42 31 in No ul 4 New ApprovalPending Administrator 3 15 2002 16 41 53 3 15 2002 16 41 53 JR dan 4 New Approval Pending Administrator 3 15 2002 16 41 53 3 15 2002 16 41 53 2 2 0000 3 Loaded as part of Approval Pending Administrator 13 15 2002 16 41 45___ 3 15 200216 21 55 A3 3 0000 3 AddedtoBatch Approval Pending Administrator Manual Integration Details 3 New Approval Pending Administrator 3 New Approval Pending Administrator Start of compare 3 15 2002 5 37 46 PM 2 New Approval Pending operator2 _ Ieee I i L Datafile 005 0102 D 2 New _ Approval Pending operator2 1 New Approval Pending operator 1 New Approval Pending operator Compare of Signal DAD1 A Sig 254 4 Ref 550 100 Comment for s
109. ChemStore C S database Users and their permissions can be imported from an existing database during creation of a new standalone database In a client server environment users are centrally managed in the Oracle database Electronic signatures and password security Agilent ChemStore C S uses elec tronic signatures based on the application User ID password combination to uniquely identify the users and their signatures In Example Only see your originals shipped with the product or handed over by the Agilent ChemSto Database administration The review client provides the graphical user interface GUI through which the user can accom plish the following administrative tasks Although the capabilities of the entry level and client server versions are to some extent differ ent the GUI is identical e Create a new database entry level database only e Compact defragment a data base entry level database only e Create or modify a study or custom fields e Administer system settings e Administer users and security e Manual or automatic archive delete and de archive data server only 16 Customer Engineer e Assign studies to users e Email notification for example on security violations server only The client server version offers supplementary tools for administra tors in the Admin Client to per form proper maintenance of the server database archive dearchive or archive
110. Detection and Quantification ME Accuracy ME Selectivity a MS Sulfamethazine ME Precision RT ME Precision Area ME Calibration Function ME Linearity ME Limit of Detection and Quantification ME Accuracy ME Selectivity a MS Sulfachloropyridazine compound centric vi Examp e 0 n ly validation in the forr nents This enables i See your originals calculations and vali each compound or p shipped with the product analytical separation structuring the valida OF h d nd ed over by th possible to define mi nents for the same c peak for example if matrix effects are investigated For each component additional sub levels offer a list of check points such as robustness linearity and others as defined in the various regulatory guidelines The planning of checkpoints is the lowest level because each checkpoint can have a different planning configuration Within the planning dialog data is configured such as the determination method the applicability of multiple injections or multiple determinations for one result data point as well as the number of result values and test specifications such as nominal expected values or limits Test execution Having completed the validation configuration the experiments can be executed on an Agilent Customer Engineer SEUUETILE IUT CALI CUITIPUTIEMIL UF UNG UF FHIUTE LUSLUIIT S UYUETILES per Validation C per Component C Custom Share Data There is
111. ECTORS G1314B C VWD Q Record serial number QO Inspect flow cell for leaks Perform Holmium Oxide Test Result Pass Fail If test fails perform Wavelength Calibration QO Perform intensity test Result Pass Fail Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 3 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist G1315B C DAD G1365B C MWD Q 1 Record model number Q 1 Record serial number Q 2 Record model number Q 2 Record serial be QO Inspect flow cell for leaks Q Perform filter test and atti to checklist O Perform dark current test Pass Fail 1 Result 2 Result Pass Fail 3 Result Pass Fail O Perform Holmium Oxide Test MW 1 Result Pass Fail MW 2 Result Pass Fail MW 3 Result Pass Fail If test fails perform Wavelength Calibration Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies QO Perform intensity test 1 Result Pass Fail 2 Result Pass Fail 3 Result Pass Fail G1321A FLD O Record serial number Example Only see your originals shipped with the product or handed over by the Customer Engineer ALI LIOL vy 1 Gil WL Excitation Verif Deviation WL Emission Verif Deviation If test fails perform Wavelength Calibration G1362A RID Q Record serial number Q Check diode balance with pure water in both the reference and the sample cell instrument
112. ED Design Qualification DQ Phase 2 Pump Specifications G1310A Isocratic Pump Performance Specifications Table 1 Performance Specification Agilent 1200 Isocratic Pump Type Hydraulic system Setable flow range Flow range Flow precision Flow accuracy Pressure Pressure pulsation Compressibility compensation Recommended pH range Control and data evaluation Analog output Communications Specification Dual piston in series pump with proprietary servo controlled variable stroke drive floating pistons and active inlet valve 0 001 10 ml min in 0 001 ml min increments 0 2 10 0 ml min lt 0 07 RSD or lt 0 02 min SD whatever is greater based on retention time at constant room temperature 1 or 10pl min whatever is greater Operating range 0 40 MPa 0 400 bar 0 5880 psi up to 5 ml min Operating range 0 20 MPa 0 200 bar 0 2950 psi up to 10 ml min lt 2 amplitude typically lt 1 at 1 ml min isopropanol at all pressures gt 10 bar 147 psi User selectable based on mobile phase compressibility 1 0 12 5 solvents with pH lt 2 3 should not contain acids which attack stainless steel Agilent ChemStation for LC For pressure monitoring 2 mV bar one output Controller area network CAN GPIB RS 232C APG Remote ready start stop and shut down signals LAN optional Agilent 1200 Series Qualification Workbook 2 Design Qualificatio
113. Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN optional LAN or external contacts interface RS232C APG remote for remote start stop signals to from other modules Interface to G1330A Thermostat CAN DC out for operation of Agilent approved external devices like valves Only one type of well plate or MALDI plate can be used at a time in one tray Physical Specifications Table 35 Physical Specifications micro collector spotter G1364D Type Weight Dimensions height x width x depth Agilent 1200 Series Qualification Workbook Specification Comments 13 5 kg 29 8 Ibs 200 x 345 x 440 mm 8 x 13 5 x 17 inches 2 Design Qualification DO Phase Table 35 Physical Specifications micro collector spotter G1364D continued continued Type Specification Comments Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption apparent 200 VA Maximum power Power consumption active 180 W Maximum power Ambient operating 4 55 C 41 131 F temperature Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the autosampler Safety standards IEC CSA UL Installation Category II Pollution Degree 2 For
114. For determi ition of molecular weight om multiply charged API ES ass spectra amp for evaluation MS data from proteins pep iles oligonucleotides s equires G2710BA LC MSD ChemStation Software or G2715BA LC MSD Add on Software module to operate e TOF Software G3300AA For CE MS TOF Computer Hardware The 32 Bit ChemStation consists of Hewlett Packard personal com puter hardware and ChemStation software The hardware is an IBM compatible personal computer with an ISA or PCI interface bus The personal computer is inter faced to the analytical instruments through a LAN card a GP nal card a USB GP IB inte or a combination of one G card and a LAN card All c plug directly into the com PCI or interface Third Pai instruments can be conne the Agilent 35900E A D Cc interface The separate ha components that comprise ticular instrument configu including third party instrumenta tion may need to be coordinated through a remote cabling system for time critical events such as injection Non HP Compaq Computers The Agilent ChemStation has been designed to successfully run on a wide range of compatible personal computers equipped with accessories and peripherals Example Only see your originals shipped with the product or handed over by the Customer Engineer and EVO computers and may not be optimized for other vendor s PCs The standard configuration Minimum PC Configuration Windows X
115. IQ Phase because the installing customer engineer will attach the originals to the Installation Qualification Protocol to demonstrate that he she has installed factory verified equipment E a Agilent Technologies Declaration of System Validation We herewith inform you that the software product system Product Name Product Number Revision Number ChemStation for GC G2070BA G2071BA G2075BA B 02 0x G2090BA where x ranges from 0 to 9 ChemStation for LC G2170BA 2171BA G2175BA B 02 0x G2180BA G2185BA G2190BA where x ranges from 0 to 9 ChemStation for A D G2072BA G2073BA G2077BA B 02 0x where x ranges from 0 to 9 ChemStation for CE G1601BA G2172BA G2205BA B 02 0x where x ranges from 0 to 9 ChemStation for CE MS G2201BA B 02 0x where x ranges from 0 to 9 ChemStation for LC MS G27 10BA G27 15BA G2720BA B 02 0x G2730BA G2731AA where x ranges from 0 to 9 Software Revision updates G1656B Not applicable was developed according to the quality process and software life cycle followed by the Life Sciences and Chemical Analysis divisions of Agilent Technologies Life cycle check point details were reviewed and approved by management The product was found to meet its functional and performance specifications and release criteria at release to shipment In order to fulfill the validation requirements of the users of this product according to current regulations and quality standards including but not limited to 21 CF
116. MU TO M4 e peak width at half height calcu lated by the true five sigma tangent and tailing methods and e plate column and plates meter calculated by the peak width at half height five sigma tangent and statistical methods Users may define their own noise evaluation ranges and acceptable limits for these performance crite ria Values lying outside the user defined acceptable limits are indi cated on the report Sequence Summary Reports Sequence summary reports are produced at the end of a series of automated analyses Their range of application is from a brief sum mary of the samples analyzed to a detailed graphical repeatability or trend analysis of user selectable parameters between different samples analyzed by the same method The reports are built up from nine optional categories of information e a header page that may be user defined e the instrument configuration including revision numbers and analytical column or capillary specifications for LC CE and LC MSD systems of samples scheduled for is book printout which what was analyzed and ents the data acquisition ocessing steps as well as expected events yut of the analytical ds ual sample reports Js on calibration samples s St tisucs on unknown samples and e asummary page that may be either a sample summary one line of information per analysis or a compound summary with a short compound summary table in addition to the sampl
117. OR Agilent Technologies e g 1200 Series Firmware Downloads patches Library http www chem agilent com Scripts Li brary asp Education http www chem agilent com Scripts ca g_countrysites asp pf T E seminars http webshop chem agilent com iccdoc s seminarList shtml Supplies http www chem agilent com Scripts P sy sp 1Page 572 rare Status Bulletins and Patches www chem agilent com scripts ca ckreg asp Password 1s the Registration yer for the software ales Order Number Q Service Order SO Number Q Date completed Q Customer Signature Q Support Provider Signature WAD Product Support Page 3 of 3 Installation Qualification I0 Phase 3 Agilent 1200 Series Liquid Chromatograph Scorp of Work Installation and Famliarization Agilent 1200 Series Qualification Workbook 3 Installation Qualification 10 Phase Declaration of Conformity and System Validation Agilent 1200 Series Qualification Workbook Installation Qualification I0 Phase 3 Declaration of Conformity According to ISO IEC Guide 22 and CEN CENELEC EN 45014 Agilent 1200 Series Qualification Workbook DECLARATION OF CONFORMITY ETS Agilent Technologies According to ISO IEC Guide 22 and CEN CENELEC EN 45014 Manufacturer s Name Agilent Technologies International sarl Manufacturer s Address Rue de la Gare 29 Supplier s Address CH 1110 Morges Switzerland Declares under sole responsibil
118. P ASTMI sn Additional header inf Header line 1 Header line 2 Header line 3 Header line 4 x Header line 5 v Selectivity Selectivity means that an analytical method can distinguish the substance to be determiend from other substances in the sample Selectivity in chromatography can be described by the relative retention of analyte and interfering substance s Optional a chromatogram BMP AYMF format can be imported Calculated value Resolution R Planning dialog of checkpoint Selectivity 57 Ring experiment Ring experiments are used to prove that a method can be successfully transferred to an entirely different location other site company etc and that it delivers appropriate results A ring experiment can be seen as a more general ruggedness test Figure 46 shows the planning dialog of the checkpoint Ring experiment Planning data e Number of rows one rc one lab e Y units e Checkmark for same nui values per lab e Multiple injections possi Output settings e Neumann trend test e Dixon or Grubbs test for outliers 4 e Variance homogeneity e Repeatability limit e Reproducibility limit Ring experiment late night wake up drug batch According to ICH Run number HPLC fantasy Agielnt 1100 for serial numbers see checkpoint header no comment Planning data EP Lab data
119. P and Windows 2000 based systems e Hewlett Packard Compaq PC with Pentium V 1 5 GHz e SXGA display 1280x1024 resolution e 40 GB hard disk e MS Windows compatible pointing device e ATAPI CD CD RW or DVD drive e 10 100 baseT LAN interface card of the GPIB interface for instance may conflict with the memory configuration of a non HP Compaq computer Additional accessory interface boards may cause conflicts of hardware related resources I O ports interrupt settings DMA channels For a non HP omputer use the setup sram supplied by the irer to configure your and check the supplied ation to eliminate onflicts in your PC s ecially regarding the ion of the GPIB inter ough the software is ned to be run on other e hardware Agilent Technologies will not necessarily accept responsibility for defects solely observed and reported on third party hardware Minimum memory specifica tions e 512 MB RAM Agilent supports the use of hyperthread ing on Pentium IV or higher PC s running Windows XP Maximum Number of Supported Instruments A maximum of four instruments may be configured per Agilent ChemStation PC The following instrument module specific limita tions exist e Amaximum of two diode array detector instruments may be configured per PC e A maximum of one variable wavelength detector VWD one pump module one autosampler mq thermostated ci ment TCC mo per instrument four i
120. R 210 Good Manufacturing Practice for Drugs 21 CFR 211 current Good Manufacturing Practice for finished pharmaceuticals 21 CFR 58 Good Laboratory Practice Agilent Technologies will make the source code and the documents referenced on page 2 of this declaration available to an authorized governmental or regulatory agency for inspection at its Pharmaceutical Solutions Unit Waldbronn Germany terms and conditions to be negotiated Agilent Technologies will maintain possession of all documents and their reproductions and may require a confidential disclosure agreement to be provided by those requiring access to these documents Date February 2006 ut Lane Pari tems PHS CAS G base Money Came PHS CAS Engineering manager Quality manager Figure 3 Declaration of System Validation Contribution of the Qualification Workbook The chapter Design Qualification DQ phase contains documents on the qualification of the vendor and on the design qualification of the equipment The user has to add further documents e g detailing his conscious decisions in the selection of the supplier 1 Agilent 1200 Series Qualification Workbook Overview 1 Installation Qualification 10 Phase Definition and frequency Installation qualification IQ establishes that the instrument is received as designed and specified that it is properly installed in the selected environment and that this environment is suitable for the op
121. Station sequence An instant file less result transfer back to the LIMS from the ChemStore C S database server only is achieved through the integrated ChemStore C S LIMS interface Sample list import from LIMS The sample list generated by the LIMS can be imported to the Agilent ChemStation as a ChemStation sequence in XML file format XML is a very portable and flexible protocol for inter connectivity between systems 18 or handed over by the Customer Engineer to the LIMS Optionally additional two fields can be populated with LIMS specific data Result update to LIMS ChemStore C S provides for file less access to all result data stored in the database as LIMS data identified by the LIMS ID This is achieved through a combination of read access to all result data in the database as well as a controlled write access for the LIMS Prerequisite for results to be accessible by LIMS is the existence of a LIMS ID which is assigned per sequence line In addition a LIMS notification may be used which is tied to the A checksum protected archive catalog file in XML format is gen erated with each archive unit which contains detailed informa tion about the content of the binary archive file A generic archive interface provides a clos er linkage to other applications for enhanced archive manage ment for example archive man agement or hierarchical storage management systems roval of data as shown in re
122. Station Add on Module G2715BA The Agilent ChemStation for LC MSD systems G2710BA and the LC MSD ChemStation Add on module G2715BA provide con trol data acquisition and data evaluation capabilities for Agilent 1200 1100 Series LC MS The G2710BA and G271 LC MS software include G2170BA LC ChemStati G2180AA diode array de DAD spectral evaluati Add on module Togeth software components pi integrated control with graphical user interface the Agilent 1200 1100 Se modules and systems including the Agilent 1200 Series DAD as well as the Agilent 1200 Series LC MSD In addition to the Agilent 1200 Series family of mod ules and systems the HP 1090 Series II liquid chromatography system as well as the Agilent 35900E A D interface can be con trolled by G2710BA as part of LC MSD systems The Agilent ChemStation for LC MSD system supports a single Agilent 1200 1100 Series LC MSD system LC MSD System Control The software provides digital con trol of the LC MSD API ion source and ion optics dynamic ramping of ion optics element voltages and control for spraying and drying gases Method specific LC MSD parameters include spectral acqui sition mode scan SIM signal sampling rate LC MSD tune file ionization mode APCI APPI or API ES mode and polarity posi tive or negative ion detection Example Only see your originals shipped with the product or handed over by the Customer Engineer mentor
123. Thermostat CAN DC out for operation of Agilent approved external devices like valves Leak detection and safe leak handling error detection and display exhaust fan for fume extraction of hazardous vapors Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Vials can be used as recommended by Agilent Technologies see List of Recommended Vials and Caps inthe manual and List of Recommended Plates and Closing Mats in the manual but must be uncapped Only the 96 deep well plates can be used without closing mats see List of Recom mended Plates and Closing Mats in the manual Only one type of well plates can be used at a time in one tray Physical Specifications Table 32 Physical Specifications Autosamplers G1364B G1364C Type Specification Comments Weight 13 5 kg 29 8 Ibs Dimensions 200 x 345 x 440 mm height x width x depth 8 x 13 5 x 17 inches Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption apparent 200 VA Maximum power Power consumption active 180 W Maximum power Ambient operating temperature 4 55 C 41 131 F Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C Non condensing 77 104 F Operating Altitude Up to 2000 m 6500 ft Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 32 Physic
124. Validation Pack software does not necessarily need to be installed on every client in a client server system If method validation is carried out on a subset of all networked ChemStation Plus clients only those clients participating in the process of validating analytical methods must have the software installed Agilent offers the complete portfolio of installation validation and training through its project services organization This will be handled as one project where the complete service delivery is managed centrally based on the individual customer requirements ChemStation Plus Method Validation Pack Product Options and Configurations Standalone version The standalone version of Method Validation Pack requires the additional installation of the ChemStation for data acquisition and the ChemStation Plus database module for data management of analytical data The database can be ordered as G2181BA ChemStore database or as G2183AA Security Pack for full support of 2 Part 11 The installation ol requires one of these proc Client server version Method Validation Pack client server installation r Oracle 91 Rev 9 2 0 3 0 A system configuration requires ChemStore C S server software G1410A for each server plus Agilent NDS Oracle user licenses G1411A for each named database user one full use copy of the ChemsStore client software G2181BA and a ChemStation Plus client license G2186BA for each connecte
125. Workbook Design Qualification DQ Phase 2 G1362A Refractive Index Detector Performance Specifications Table 29 Performance Specifications Agilent 1200 Series Refractive Index Detector Type Detection type Refractive index range Measurement range Optical zeroing Optics temperature control Sample cell Valves Volumes Liquid contact materials pH range Performance specifications Time programmable parameters Detector zero Specification Comments Refractive Index 1 00 1 75 RIU calibrated 600 x 10 RIU via set screw 5 C above ambient to 55 C volume 8uL maximum pressure 5 bar 0 5Mpa maximum flow rate 5mL minute Automatic purge and automatic solvent recycle Inlet port to sample cell 62uL inlet port to outlet port 590uL 316 stainless steel teflon and quartz glass 2 3 9 5 Short term noise see note below this table lt 2 5x 1073 RIU Drift lt 200 x 10 RIU hour polarity peak width automatic zero before analysis Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 29 Performance Specifications Agilent 1200 Series Refractive Index Detector continued Type Specification Comments Control and data Parameter entry signal display evaluation on line help and diagnostics with the Agilent 1200 Series Control Module Optional PCMCIA card for method sequence and logbook storage and transfer Agilent ChemStation fo
126. Workbook Design Qualification DQ Phase 2 Table 23 Performance Specifications Agilent 1200 Series Variable Wavelength Detector continued Type Flow cells Control and data evaluation Analog outputs Communications Safety and maintenance GLP features Housing Specification Comments Standard 14 ul volume 10 mm cell path Can be repaired on component length and 40 bar 588 psi pressure level maximum High pressure 14 ul volume 10 mm cell path length and 400 bar 5880 psi pressure maximum Micro 1 ul volume 5 mm cell path length and 40 bar 588 psi pressure maximum Semi micro 5 ul volume 6 mm cell path length and 40 bar 588 psi pressure maximum Agilent ChemStation for LC Recorder integrator 100 mV or 1 V output range 0 001 2 AU one output Controller area network CAN GPIB GPIB for G1314B only RS 232C APG Remote ready start stop and shut down signals LAN optional Extensive diagnostics error detection and display through control module and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas Early maintenance feedback EMF for continuous tracking of instrument usage in terms of lamp burn time with user settable limits and feedback messages Electronic records of maintenance and errors Verification of wavelength accuracy with built in holmium oxide filter All materi
127. a access compo nents MDAC 2 8 will be installed on your system If you already use a later version of MDAC or require for compati bility reasons a previous ver sion please contact your Agilent support representative for compatibility information e Oracle 9i client version 9 2 0 3 0 included with the ChemStore C S server software e Agilent ChemStation version A 10 01 or higher optional e Alocalor network printer must be installed and configured Customer Engineer can thus grow to approximately 50 acquisition clients with a maximum of 90 instruments It is therefore Entry level No of concurrent review clients 1 5 Processor speed GHz 1 Number of processors 1 RAM MB 512 Number of RAID controllers 1 Disks for operating system 2 x 18 GB RAID 1 Disks for Oracle database 3 x 18 GB RAID 5 RAID 5 Hot swappable drives ves Backup device UPS Table 2 yes DAT DLT tape drive recommended to use a high speed dual processor system with suffi cient RAM The minimum requirements for the server in a Client Server installa tion are the following e 600 MHz Pentium III processor e 512 MB RAM e RAID SCSI controller e 6 disk drives 9 GB or larger 2 drives configured as a mirror set and 4 drives configured as a RAID 5 array e Tape Device 1terruptable Powersupply lS ive configuration yields one ed partition for the operat tem and application soft and one large array for the se files r ha
128. ack stainless steel High pressure binary mixing delay volume 180 480 pl without mixer 600 900 ul with mixer dependent on back pressure 1 99 or 5 pl min per channel whatever is greater 8 5 absolute 0 15 RSD at 1 ml min Agilent ChemStation for LC For pressure monitoring 2 mV bar one output Controller area network CAN GPIB RS 232C APG Remote ready start stop and shut down signals LAN optional Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 5 Performance Specification Agilent 1200 Binary Pump continued Safety and maintenance Extensive diagnostics error detection and display through handheld controllers G4208A G1323B and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas GLP features Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase with user settable limits and feedback messages Electronic records of maintenance and errors Housing AII materials recyclable For use with flow rates below 500 pl min a vacuum degasser is required Physical Specifications Table 6 Physical Specifications Type Specification Comments Weight 15 5 kg 34 Ibs Dimensions 180 x 345 x 435 mm height x weight x depth 7 x 13 5 x 17 inches Line voltage 100 120 or 220 240 VAC 1
129. afety Standards IEC CSA UL 345 x 435 x 80 mm 13 5 x 17 x 3 1 inches 100 120 or 220 240 VAC 10 50 or 60 Hz 5 30 W 0 55 C 32 131 F 40 70 C 4 158 F lt 95 at 25 40 C 77 104 F Up to 2000 m 6500 ft Up to 4600 m 14950 ft Installation Category II Pollution Degree 2 Wide ranging capability Maximum see User manual Non condensing For storing the instrument This temperature range represents the technical specifications for this instrument The mentioned temperatures may not be suitable for all applications and all types of solvents WARNING Never operate your instrumentation under conditions other than specified by the vendor Operating the instrumentation under conditions other than their intended use might result in a potential safety hazard or might damage the instrumentation Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase G1379B Micro Vacuum Degasser Performance Specifications Table 45 Performance Specifications Agilent 1200 Micro Vacuum Degasser Type Specification Maximum flow rate 0 5 ml min per channel Number of channels 4 Internal volume per channel Typically 1 ml per channel Materials in contact with solvent PTFE FEP PEEK pH range 1 14 RS 232 output For diagnostic purposes The Agilent 1200 Series micro vacuum degasser has been tested for evaporation of solvents into the atmosphere by an i
130. affeine Kit Holmium Oxid Glass Filter Type Hoya HY 1 Customer contributed material For the items marked with a example pages are added It is the responsibility of the user to replace these with the originals Documents for calibrated test equipment are handcarried by the Agilent Technologies customer engineer who performs for example the 0Q PV procedure Copies of these documents should be added to the present binder The user should feel free to add further documents e g not supplied by Agilent Technologies whenever he thinks this is appropriate Fip Agilent Technologies 4 Operational Qualification 00 Phase 00 PV Protocols e Agilent 1200 Series modules e Agilent ChemStation Plus Add here the protocols as handed over by a certified Agilent service engineer after an Operational Qualification OQ Recommended times for OQ Installing hardware or software Repairing a mayor piece of hardware Any software change that affect system security data integrity or administrative controls Agilent 1200 Series Qualification Workbook Operational Qualification 00 Phase 4 Agilent ChemStation Verification Test Report Agilent 1200 Series Qualification Workbook Test Name C CHEM32 1 VERIFY LCAREA VAL Tested Configuration Component o_o oc a Cerolini Microsoft Windows Processor CoProcessor ChemStation for LC 3D systemsRev B 02 01 241 Microsoft Windows 2000 Intel Pentium Pro ves O eS 1 SS ES SS SS
131. ai rai If you have problems in provic 5 ee yo ur orl g ina 5 tact your local Agilent Technologies office for assistance Assistan sh p p d with th e p ro d uct contracted separately or handed over by the PLEASE NOTE gt Customer Engineer o Some of the instrumentation J je some of the individual modules that generate a system are not sold asurviauar pares For example if you ordered a G1354A you will receive a G1311A Quat Pump and a G1322A Micro Vacuum Degasser G1382A you will receive a G1376A Capillary Pump and a G1379B Micro Degasser G2225A you will receive a G2226A Nano Pump and a G1379B Micro Degasser If you have ordered a bundled system or if you have problems in identifying the individual modules that are part of your system please contact your sales representative for information about the individual modules that generate this system Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 1 of 8 Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification Le Dimensions and Weight C Select the laboratory bench space before your system arrives Pay special attention to the total height requirements Avoid bench space with overhanging shelves Pay special attention to the total weight of the modules you have ordered Make sure that your laboratory bench can support this weight CT Depth_ Width Pumps G1376A Capillary Pump 17 7 39 Ibs
132. al Specifications Autosamplers G1364B G1364C continued Type Specification Comments Non operating altitude Up to 4600 m 14950 ft For storing the autosampler Safety standards IEC CSA UL Installation Category II Pollution Degree 2 For indoor use only Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase G1364C ANALYTICAL SCALE Fraction Collector Table 33 Performance Specifications Agilent 1200 Series ANALYTICAL SCALE Autosampler G1364C Type trigger modes operating modes fraction vessel Capacities and trays Specification Time slices Peak threshold up downslope Timetable combination of time intervals and peak and Manual trigger supported only with G1323B Control Module Agilent 1200 Series DAD MWD detectors G1315A B C G1365 A B C the Agilent 1200 Series fluorescence detector and the Agilent G1946C D G1956A B LC MSD are fully supported other detectors can be used but are not supported for fraction collection Discrete fractions default mode for all vessels The flow is diverted to waste while moving from one vessel position to the next vessel position Continuous flow optional available only when using the deep well plates It is possible to move from one well plate position to the next one without diverting the flow into the well plate to waste Needle into location Needle pushes into the vessel as deep as specified for the use with capped vials and test tubes a
133. al module can import spectra stored in Agilent s WAV format files from the HP 8452 and 1 A AYA CN 1 Example Only see your originals shipped with the product m or handed over by the t Customer Engineer OLALIOLL LESISLEL LES OI LILLO ugi L the Windows clipboard High Throughput Purification Software Module Purify The High Throughput Purification software module G2262AA is designed for the needs of prepara tive HPLC It offers utmost flexi bility for purification of large numbers of samples For efficient data review the graphical user interface provides an easy way for sample and fraction tracking Sophisticated import and export functionality allov lin gration of the syst In addition the MS based fraction collection add on software pack age G2263AA allows fraction trig gering based on up to 16 masses And Or fraction logic on UV and MS or other signal offers highest flexibility for complex purification tasks Note This module requires MNT A Nr a TD MV NT NTT cation workflow Example Only see your originals shipped with the product Agilent Chem The Agilent Chen may be added to any Agilent ChemStation configuration The specifications for this product may be found in the dedicated Agilent ChemStation Plus Specifications document Note This module requires ChemStation B 2 01 SR1 or handed over by the Customer Engineer database client SC verrerie Agilent Chemstatio
134. al number source oxidation or physical damage i e O Inspect nebulizer and needle for cracks inside source Issued Nov 2005 Rev 3 0 Copyright 2005 Agilent Technologies LC MS Technical Marketing Page 2 of 3 Agilent 1100 1200 Series LC MSD Quad nt uit T i Agilent Technologies Maior Preventive Maintenance Checklist O Inspect nebulizer and needle for Q Service Order SO Number physical damage i e damaged tip or corrosion O Note any obvious external damage Y Date completed or problems Q Replace the APCI corona needle O Customer Signature G1947 20029 Q Replace and properly adjust the nebulizer needle G1946 60136 Q Support Provider Signature Q Clean all other interior spray chamber includi with a lint free cloth w Exa a p i A 0 n ly O Verify that all temperat 5 BE VO Uro ri Na S pressures and gas flow file set points shipped with the product O Check manually that y or handed over by the peaks in positive and n Generate tune reports ii C Li sto mer I g i neer negative mode i ne P Q Add results to PM documentation Service Review Q Record in Instrument Logbook that a Major PM was performed O Affix the PM Sticker to the 1100 1200 LC MSD Quad system or in the customer logbook as specified by the Customer Note The purpose of generating tune reports after planned maintenance is to verify that the system is functional in positive and negative modes Autotu
135. als recyclable Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase ASTM Standard Practice for Variable Wavelength Photometric Detectors Used in Liquid Chromatography Reference conditions cell path length 10 mm response time 2 s flow 1 ml min LC grade methanol Linearity measured with caffeine at 265 nm Physical Specifications Table 24 Physical Specifications Type Specification Comments Weight 11 kg 25 Ibs Dimensions 140 x 345 x 435 mm height x width x depth 5 5 x 13 5 x 17 inches Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption 220 VA 85 W 290 BTU Maximum Ambient operating temperature 0 55 C 32 131 F Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C Non condensing 77 104 F Operating altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the instrument Safety standards IEC CSA UL Installation Category Il EN Pollution Degree 2 For indoor use only Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1315B Diode Array Detector G1365B Multible Wavelength Detector Performance Specifications Table 25 Performance Specifications Agilent 1200 Series DAD and MWD Type Specification Comments Detection type 1024 element photodiode array Light source Deuterium and tungsten lamps Wavelength rang
136. alve Delay volume 800 1100 HI dependent on back pressure 0 95 or 5 100 user selectable lt 0 2 RSD at 0 2 and 1 ml min Agilent ChemStation for LC For pressure monitoring 2 mV bar one output Controller area network CAN GPIB RS 232C APG Remote ready start stop and shut down signals LAN optional Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table3 Performance Specification Agilent 1200 Quaternary Pump continued Safety and maintenance Extensive diagnostics error detection and display through control module and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas GLP features Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase with user settable limits and feedback messages Electronic records of maintenance and errors Housing AII materials recyclable Physical Specifications Table4 Physical Specifications Type Specification Comments Weight 11 kg 25 Ibs Dimensions 140 x 345 x 435 mm height x weight x depth 5 5 x 13 5 x 17 inches Line voltage 100 120 or 220 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption 220 VA Maximum Ambient operating temperature 4 55 C 41 131 F Ambient non operating 40 70 C 4 158 F te
137. ame sample receive only one sequence line but write the number of injections in the related sequence column The MVS files automatically include information on the sample type number of injections and sample nama Tha nmommmls nam nanfarnanaga n b run MVS sequences the opera x only fills in the vial position xr the samples and starts the quence For further details on hemStation functionality please fer to ChemStation specifica ons Agilent Technologies publi ition number 5988 53 14EN amp Instrument 1 offline 1 Method amp Run Control chr nickel File RunControl Instrument Method Sequence EIREINGIEA View Abort Help Method and Run Control BATCH Single Run gt Sequence Sequence Setu Seu ESS v Method Yalidation TE SS Sequence a MTHVAL S Done sample runs no Details Dof 1 90 80 60 Current Logbook File INSTR1 LOG CP Macro Saving Sequence MTHVAL S Saving Sequence MTHVAL S Saving Sequence MTHVAL S Loading Sequence MTHVAL S Loading Method BATCH M Welcome to ChenStation Closing ChenStation Data spooled to demo 10 50 33 03 13 02 10 50 23 03 13 02 10 50 13 03 13 02 10 50 12 03 13 02 10 50 11 03 13 02 10 49 38 03 13 02 01 34 23 03 08 02 01 06 30 03 08 02 01 05 43 03 08 02 00 54 08 03 08 02 00 53 09 03 08 02 C Adata Demo C MB free Loading Method BATCH M Data spooled to demo Loading Method BATCH M ChenStore Method KIS Fig
138. and description of the import mask e source type file extension and path ies e field separator d e row options e data positions all exclude header a with optional tre the data and e column informati information for n tions and determ The import settings as import mask and applied at any later time to import data The system can handle multiple data import masks allowing to quickly import results from various data sources Level 1 Reporting Method Validation Pack software offers multiple reports Users can have e planning reports print all data from the planning dialog e graphics report for each checkpoint prints only results in graphic representation e complete reports on check point level component level and e complete validation reports with all validation settings and all component and checkpoint results The validation report includes the following parts e Page header and page footer Footer includes printed user name date page of and a signature placeholder for manual report sign off e Report title page e Default comment page e Table of contents with page numbers A c Example Only See your originals shipped with the product or handed over by the Customer Engineer explanatory text and a complete legend of the variables and symbols This function is enabled on a global level via the report options as part of the program options e validation audit t
139. aphy for that run e For details on the size of raw data files by technique Example Only see your originals shipped with the product or handed over by the Customer Engineer Store in Addition Description Chromatograms Spectra for quantified Stores all available chromatograms from each detector and or signal Stores spectra from all peaks that have been identified and quanti Stores the acquired data in addition to the calculated result This setting has a significant effect on the amount of storage space required for each run in the ChemStore C S database For example ChemStation data which is created from 3D techniques such as a liquid chromatography diode array detector will require more storage space than a 2D technique such as gas chromatography peaks fied as compounds in the calibration table Raw data Note Sequence Stores the ChemStation sequence Method Stores the ChemStation method Table 4 Store in Addition study settings e Retention time locking software add on module for Agilent ChemStation for gas chromatography e Agilent ChemStation for liquid chromatography revision A 10 01 or later e Gel permeation chromatogra phy software add on module for the Agilent ChemStation for LC e Agilent ChemStation for capillary electrophoresis revi sion A 10 01 or later e Agilent ChemStation for liquid aatography mass selective tion revision A 10 01 or at ChemStation for analog acquisitio
140. artment Performance Specifications Table 47 Performance Specifications Agilent 1200 Series Thermostatted Column Compartment G1316A G1316B Type Specification Comments Temperature range 10 degrees below ambient to 80 C G1316A 10 degrees below ambient to 100 C G1316B SL up to 80 C flow rates up to 5 ml min G1316A G1316B SL up to 100 C flow rates up to 2 5 ml min G1316B SL Temperature stability 0 15 C G1316A 0 05 C G1316B SL Temperature accuracy 0 8 C 0 5 C With calibration Column capacity Three 30 cm Warm up cool down 5 minutes from ambient to 40 C time 10 minutes from 40 20 C Dead volume 3 ul left heat exchanger i d 0 17 mm 6 ul right heat exchanger Dimensions 140 x 410 x 435 mm h x w x d 5 5 x 16 x 17 inches Weight 10 2 kg 22 5 Ibs Communications Controller area network CAN GPIB no GPIB on G1316B SL RS 232C APG Remote ready start stop and shut down signals LAN via other 1200 series module Safety and maintenance Extensive diagnostics error detection and display through control module and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 47 Performance Specifications Agilent 1200 Series Thermostatted Column Compartment G1316A G1316B continued Type Specification Comments
141. asks and the ChemStore C S database data review privileges The entire user administration itself is a user privilege granted to administrators in the ChemStore C S database The ChemStation Plus Security Pack includes a modified ChemStation operator level allowing operators to perform all important acquisition and data analysis tasks for daily operations Table 12 shows the most important changes in user 28 privileges compared to the standard ChemStation for data acquisition The ChemStation Manager always has access to all tasks within the ChemStation with the exception of access to the ChemStation command line Unlike the standard ChemStation this privilege can be User privilege Save acquisition method Save data analysis method Load run save sequence Modify acquisition parameter Re Integrate chromatograms manually Change integration events Recalibrate overview and peak summing Recalibrate other Apply method to data and print report User independent automated result versioning Access to tasks with manual result versioning Table 12 Data directory owner contents Contains database mdb file storing all raw and meta data All members of local Admini strators or Power Users group All members of local Admini strators or Power Users group Spooler jobs and data files Access to ChemStore utility tool to create copy and manage local database files All members of local Admini Strators or P
142. at least 40 GB free capacity 1280x1024 recommended resolution or better graphics adapter and monitor True Colors 82350A B GP IB card available with one free IRQ on the PC and one free PCI slot Copyright 2006 Agilent Technologies CHE Agilent Technologies Q Available LAN interface with TCP IP protocol installed and a LAN card J4100A JetDirect card G1369A LAN card or equivalent for the instrument if needed Q A printer supported by the current version of the ChemStation For further information please contact your local service representative or ne ChemStation installation manual f your appropriate technique he voltage setting of the computer ystem and the power cables has to e correct uled information on how to set up ows XP Professional for optimal Station usage is located on the ChemStation CD ROM under the manuals installation Configure and Maintain you Agilent PC directory Please verify if your instruments support GPIB connection WAD Product Support Page 1 of 3 Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2073BA G2170BA G2171BA G2171BA G2180BA G2090BA G2710BA G1601BA G2201BA B 02 01 Upgrade Site Prep Checklist Instrument Hardware Requirements LC GC and LC MS QI For LC systems only QI Check if Firmware revisions of For GC systems only GC Column Catalog A GC Column Database Utility is available to transfer user defined GC columns fro
143. atabase Working with ChemStation Plus Method Validation Pack General software operation Compatibility with Microsoft functionality Method Validation Pack is a Microsoft Windows program and can be operated via mouse and keyboard in accordance with the Microsoft Windows standard Users of Microsoft Windows programs should easily become familiar with operating Method Validation Pack Context menu When working with Method Validation Pack the right mouse button opens the contex displaying your current options The context me consist of functions con a selected component 0 attributes of a graphic o All functions of the cont are also accessible via tl menu bar User interface setting All settings that are changed in the menus or tool bars are recorded for the user and saved at the end of a session They are automatically loaded during the users next login Navigation bar On the left side of the screen the navigation bar presents the most important top level functions of Method Validation Pack You can use this bar for directly selecting the e program default validation or current validation audit e Document Management System DMS export dialog import wizard for templates new validation wizard planning wizard e report settings output formats etc and e security settings Ease of operation All important tasks in Method Validation Pack are accompanied by wizards to make it easier
144. atabase uses Oracle which allows for a much larger database Additional standalone databases can be cre ated via the Agilent ChemStore C S utility 2 Agilent ChemStore C S server Oracle database system Client hardware requirements The following list shows the mini mum requirements for the client in a client server installation e 600 MHz Pentium III Pentium IV recommend e 4 GByte of free hard disk space e 128 MB RAM for single Chem Station instrument 256 MB is recommended for best perfor mance for Windows XP the minimum requireme e 256 MB RAM for twi Station instruments more is recommend performance e Display 1024 x 768 65 thousand c Server hardware requirements Agilent has optimized the perfor mance of a ChemStation Plus client server system to an average of 30 concurrent Agilent ChemStation Agilent ChemStore Review clients where concurrent clients are defined as clients con nected to the central ChemStore C S data organization system that actively either spool data to the database or perform interactive queries review client Due to the nature of the application the impact of data retrieval is higher as Example Only See your originals shipped with the product or handed over by the Client software requ e Windows 2000 Profe Service Pack 4 or Wasser Profession Service Pack la e Microsoft TCP IP protocol e Microsoft Internet Explorer 5 5 or later e Microsoft dat
145. ation F e Procedure standard e Critical value yk e Residual standard c additional for calik method Accuracy Accuracy is a qualitati measure describing th of correspondence be the expected value and the conventional value Accuracy is influenced by systematic errors The systematic error is divided into a constant systematic error and a proportional systematic error A constant systematic error is not influenced by the concentration of the substance to be determined If the error is influenced by the concentration it is a proportional systematic error A qualitative measure for accuracy of a result is its systematic deviation Figure 44 shows the planning dialog of the checkpoint accuracy Method Validation Pack provides a set of different determination methods some involving a comparison with a second method The standard addition method is used in trace analysis and determines the matrix influence The extended spiking method allows constant and proportional systematic errors to be determined even when there are no samples with known 56 Exar See your originals shipped with the product or handed over by the Customer Engineer ES Limit of detection quantification Headers batch According to ICH Run number HPLC fantasy Agielnt 1100 for serial numbers see checkpoint header no comment Test criterion X Dimension Meas sys QS Number Device type Device No
146. ation Workbook 2 Design Qualification DO Phase Table 21 Physical Specifications sampler G136 7B C G1377A continued Type Specification Comments Operating Altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the autosampler Safety standards IEC CSA UL Installation Category II Pollution Degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1377A Micro Well plate Sampler Performance Specifications Table 22 Performance Specifications Agilent 1200 Series Micro Well plate sampler Type GLP features Communications Safety features Injection range Precision Pressure range Sample viscosity range Sample capacity Injection cycle time Carry over Agilent 1200 Series Qualification Workbook Specification Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN RS232C APG remote standard optional four external contact closures and BCD vial number output Leak detection and safe leak handling low voltages in maintenance areas error detection and display 0 01 8 ulin 0 01 ul increments with the small loop capillary 0 01 40 pl in 0 01 ul increments with the extended loop capillary Typically lt 0 5 RSD of peak areas from 5 40 ui Typically lt 1 RSD from 1 5 pl Typically lt 3 RSD from 0 2 1 pl up to 400 bar 5880 psi 0 2 5 cp 2 x well p
147. ator For a fast and eas development the c is equipped with ei e Create Table de items for the ca e Create Subtable A of data sa F T Exam le O nl 215 Allobarbital 1 Peak Area area ratio check a eee eat N ree 1229 025024 _1 02800716692323 pass EE O Ur O in ci G 7912707 1 02984905809629 pass i i i i 5 916951 1 05103929371732 fall i ide a m F 1223 926147 1 02978505859145 pass____ Lat P J 1226 924927 1 02889442802885 pass r i OT a fl a OVE j t 1185 370117 1 02873822235895 pass i 1184 911377 1 02929649058471 ic Mi Ta aF __1186 058594 1 03127037836716 fail l 1189612549 1 02933453251593 pass___ e Insert Column allows to define columns that are populated with calculation results and can be used in further calculations e Define Variable allows to specify variables fixed values or calculation results that can be used in further calculations e IF condition defines conditional values for example for limit checking resulting in a con Functions Exponential Natural logarithm Logarithm Square Square root Add to expression Setup of custom expressions 1225 994751 1 02952501221598 pass 1179 390747 1 02866977385231 1230 894409 1 02854151561915 pass __1231 750488 1 02966314879187 pass___ 1191 549561 1 02993307972021 1190 345825 1 03105458701466 fsl i ere Bal
148. automatically Q In Agilent LC Diagnostic describe Status Report and how to edit a report as PDF or as printable file O In Agilent LC Diagnostic method using the Example Only Info for specifying a Start Location See your originals Generate and run a Fi Collection Sequence shipped with the product Fraction Start positio or han ded over by the Sequence Parameters Sequence Table Customer Engineer Demonstrate how to Demonstrate how to do sample Recovery if applicable appropriate trays and configuration must be available Demonstrate how to generate a report including Fraction Tickmarks and Fraction Table Maintenance Diagnostics Issued Feb 2006 Rev 4 0 Introduce the diagnostic tools in ChemStation and Agilent LC Diagnostic Describe EMF Utilities and how to set limits in ChemStation Agilent LC Diagnostic Demonstrate troubleshooting using diagnostics in ChemStation Agilent LC logbook date and time install was completed Q Explain Agilent warranty for Hardware Software and return policy for the Instrument Service Center Q Explain how to log an instrument service call Q Explain support services Q Explain how to use manuals Q Advise customer of additional training options Q Give the customer a tour of the following useful Agilent web sites Technical Support http www chem agilent com Script s cag_techsupport asp Copyright 1995 Agilent Technologies ay dg T
149. base file format adheres to a common standard which is used by many other applications for example MS Access The client server version is based on an Oracle relational database Hardware requirements The following list shows the mini mum hardware requirements for the client application e 600 MHz Pentium III Pentium IV recommend e 4 GByte of free hard disk space entry level system each validation is Stored in a separate validation database on the local hard disk file extension VDB its 128 MB RAM for single Chem Station instrument 256 MB is recommended for best perfor mance for Windows XP the minimum requirement is 256 MB e 256 MB RAM for two Chem Station instruments 512 MB or more is recommended for best performance e Display 1024 768 small fonts 65 thousand col ors Method Validation Pack installs and runs on the same instance of the Oracle database as ChemStore C S and thus does not require a separate Oracle licence For server hard ware requirements please refer to the server hardware requirements 43 for ChemStore on page 5 Software requirements e Windows 2000 Professional with Service Pack 4 or Windows XP Professional Service Pack la e Agilent ChemStation revision A 10 01 or later e Agilent ChemStore C S B 03 01 or higher e Microsoft Internet Explorer 5 5 or later e Microsoft data access components MDAC 2 8 will be installed on your system If you already use a late
150. ble to any software operator nent display of current il Validation Pack always esp ys the current user in the title bar The system displays the current user name and the database information The database is either displayed as local login for a standalone database connection or as the Oracle database alias if the system is connected to an Oracle database as shown in figure 51 ill gt Permanent display of current user name and database connection with Method Validation Pack software 63 Agilent ChemStation Plus Method Validation Pack Audit trails and change documentation Audit trails The Method Validation Pack audit trail tracks all actions that users execute during program operation The audit trail is user independent can not be modified nor deleted and it is completely system generated Method Validation Pack has three different audit trail levels as shown in figure 52 e program audit trail e default validation audit trail a and f e validation audit tra The default display si audit trail can be con audit trail window TI entries for display mu 25 and 30000 All audi printed to a printer T audit trail can also b the overall validation is a global setting and has to be enabled for generating the report For easier searching through the audit trail users can group the audit trail entries All audit trail column headers are available as grouping criteria The
151. book Contribution of the Qualification Workbook The chapter Performance Qualification PQ phase contains examples of documents to demonstrate that the equipment performs according to a specification for its routine use It also contains documents to show that it is well maintained Typical examples are e System suitability reports e Copies of maintenance logbooks e Maintenance checklists System suitability reports have to be updated by the user depending on the frequency determined during method development and validation of the method The other documents need to be updated based on EMF information and whenever Planned Preventive Maintenance is performed Heinz Goetz Ph D 1200 Series Worldwide Product Manager AGILENT TECHNOLOGIES R amp D and Marketing GmbH amp Co KG Ger 76337 Waldbronn Agilent 1200 Series Qualification Workbook 1 Overview References 1 L Huber LC GC 16 2 149 156 2 M Freeman M Leng D Morrison and R P Morrison Pharm TechnOl Eur 7 10 40 46 1995 3 P Bedson M Sargent Accredidation and Quality Assurance 1 6 265 274 1996 4 United States FDA Guide to Inspection of Pharmaceutical Quality Control Laboratories Final Rule USA FDA Rockville 1993 Copyright Agilent Technologies Company 2006 All rights reserved Reproduction adaption or translation without prior written permission is prohibited except as allowed under the copyright laws The informatio
152. ceability from method validation pack results to ChemStation Plus result man agement This is particularly useful for example if you notice outliers in your method validation In order to check the integration and decide whether Example Only See your originals shipped with the product or handed over by the Customer Engineer CITE TESUILS ana tie YUality OL Ute integration The graphical result review such as inspecting the baseline of the chromatogram or zooming in to check the integration is done in the chromatogram view of the review client If any rework is required the data can be sub mitted to the ChemStation batch review user interface for graphical rework and data reanalysis as described in the section Agilent ChemStation Plus Security Pack Graphical Result Review and Calculation These steps generate a new result version that is then used for the validation instead of the initial version If a result was obtained by applying manual inte gration events it will be marked as such in the validation report The result is transferred to the data base and the change is document ed in the run related audit trail The user decides if the validation is a development validation or a final validation that must run under full 21 CFR Part 11 conditions In the former case users with administrative rights can configure the level of audit trail for the idation and the study settings the ChemStore study This is
153. cessing tasks on the CPU and are not recommend ed for use with the Agilent ChemStation on line sessions Operating System The Agilent 32 Bit ChemStation requires Microsoft Windows 2000 Professional with Service Pack 4 Methods and Sequences The Agilent ChemStation analyti cal method fully describes how a particular separation is performed It contains all the parameters for instrument control data acquisi tion and evaluation including System Configuration The configuration of the ment system is done thre configuration editor prog Data Model The ChemStation softwa designed around a data 1 based on a memory strucuure called a register Registers are multi purpose structures that can hold analytical data and information for both two dimen sional e g time intensity and three dimensional e g time inten sity wavelength analyses The ChemStation provides com mands and functions to construct expand extract and where it does not alter primary data edit registers Registers hold information about their contents in register headers The registers are further subdivid ed into one or more objects Typically an object holds data that describes an analytical mea surement such as a chromatogra phy signal Each of these objects or Windows XP Professional with Service Pack 2 integration quantification and reporting The system may be set up to acquire data from a number of samples by different meth
154. ch report e Methods saved data and the run logbook in one checksum protected binary file This is an uneditable binary for mat that ensures the integrity of the results The file includes a revisioning scheme that indi cates if data has been reprocessed e Control sample types may be defined in the sequence table and used to automatically check the instrument perfor mance against quality control sample results when the instru record the acti Exa mM ple Only time of the an the complete r see your originals the reported di date The metl shipped with the product the completior ical steps or handed over by the Customer Engineer e All reports havi and traceable page numbering page x of y style The user may select the level of detail in each report ranging from simple summary reports to complete system details see Reporting section e GLP save register files specified as part of the method configura tion save all the original data including sample information data analysis method chro matographic signals instrument conditions integration and quantification results report NS ee Ar ye eg Gh PS ee ToS Instrument Control The instrument control capabili ties of the Agilent ChemStation may be expanded through the pur chase of additional instrument Agilent ChemStation for GC Instrument Control and Data Acquisition with the Agilent ChemStation for GC G2070BA and
155. cilitate international compliance programs products and services Agilent employs experts like Ludwig Huber Ph D Worldwide Product M arketing M anager for HPLC products and pharmaceutical industry solutions at Agilent Technologies Dr Huber serves as a consultant for industry and regulatory agencies on laboratory compliance issues like the US PDA task force on 21 CFR Part 11 and on the GAM P Special Interest Group for Laboratory Equipment He is also on the advisory board for the European Compliance Academy It is this sort of expertise that drives our compliance programs and enables them to deliver the results your lab demands This level of experience and wealth of knowledge is available online by registering for one of the many e seminars by contacting the Agilent compliance team directly at www agilent com chem or by contacting Dr Huber directly at ludwig_ huber agilent com or via telephone at 49 7243 602209 For more Information visit us at www agilent com chem Confidence is knowing you ll never be burned by compliance Confidence begins with knowing that Agilent s internal procedures are as exact and traceable as the procedures we employ at laboratories worldwide We utilize exact documentation paths to create test and review the products and services we Offer Our service professionals arrive at your site trained and certified under a factory program registered to ISO 9001 with training records for our
156. ckly while the transfer continues in the background and guarding against data loss in case the database insert opera tion fails or the network is down From database to the Agilent ChemStatic Runs which require f rework for example integration can be tr from the database to ChemStation Agilent C S creates an Agilen batch to ensure a col of operation The set batch submission is approach Wa 1 Create the batch request from the Agilent ChemStore C S review client by marking the runs for transfer in the user interface An authorized user configures the transfer details in an interactive pop up window figure 5 These include assigning the run data to one or in case of several runs to more than one user for reanaly sis on a per run basis optionally transferring the method with the data including the choice between all versions of the method and entering a comment with each run transfer that will be dis played to the Agilent ChemStation operator Use the Agilent ChemStation Load Batch from ChemStore 10 Create new batch Sample name Procaine decay Wid CPC 135 Procaine decay WADFC T iii A A ESE O Example Only see your originals shipped with the product or handed over by the Customer Engineer Figure 5 Batch setup for data transfer from database to the Agilent ChemStation m
157. constant systematic error is not influenced by the concentration of the substance to be determined If the error is influenced by the concentration it is a proportional systematic error A qualitative measurement for accuracy is the systematic deviation of the result Comparison with the nominal value There are two tests to compare the results of the analysis with the nominal value the nominal value t test and the Vvilcoxon Matched Pairs Signed Rank Test The t test tells you whether the nominal value lies within the range of confidence of an analytical result The Wilcoxon test checks whether the distribution of values nf nne measuring row is svmmetrical arnund a nominal x 49 study name method name method text instrument name instrument module with serial numbers run Ids database Ids run Id with version number run Ids and approval status run Ids and raw data file path and e all custom fields with data entries The system allows 8 5 additional header i information from th database After the planning p completed the plani procedure can be al translated into one ChemStation sequer Validation Pack pro ability to submit a sequence e per validation e per component or e as a number of custom sequences to the ChemStation When choosing to create a sequence per validation the software generates a single sequence containing all necessary sequence lines to complete all tes
158. contitions Sample Info sample Isocratic standard sample DAD slit 2nm all in peak spectra DAD UV 40 C method isocra m 30 Water 70 ACN Column Description Eclipse XDB C18 Column 4 6 x 150mm Sum Product 95993967 906 Batch Serial Diameter 4 6 mm Length 150 0 mm Particle size gt pog am Void volume 68 0 Maximum Pressure 400 bar Maximum pH 9 Maximum Temperature 67 Comment Example Only See your originals shipped with the product or handed over by the 4 Customer Engineer DADI A Sig 254 4 Ref off PMP1 Solvent A PMP1 Solvent B PMP1 Solvent C PIMP 1 Solvent D PMP1 Flow THM1 Temperature Left THM1 Temperature Right PMP 1 Pressure mAU 140 120 80 i Calib Data Modified Friday February 24 2006 4 58 12 PM O e 1 732 3 445 Instrument 1 24 Feb 06 5 39 25 PM Page lL gf 2 Data File C CHEM32 1 DATA DEMO ISOCRA D Sample Name Isocratic standard sample Multiplier 1 0000 Dilution 1 0000 Use Multiplier amp Dilution Factor with ISTDs Signal 1 DADI A Sig 254 4 Ref off Noise determination Time range Noise Noise Noise from Ed 6 SD PtoP ASTM Wander Drift min min mAU mAU MAU mAU mAU h oe eee eee eee eee 0 000 0 500 6 525e 2 4 739e 2 2 975 2 000 3 000 8 137e 2 6 124e 2 da 4 000 6 000 7 300e 2 7 030
159. ction and retransfer to batch e reloading data to disk e archiving and dearchiving and e re opening of read only runs The automated entries in the sample audit trail are created when e a run is transferred t database e anew result version e a run is reloaded in tl ChemStation batch re interface for reanalys Database logbook The database logbook stores all application rey ities such as e log on log off events and failed logon attempts archive delete reopen activities session locks and unlocks approval and rejection of runs modification of custom fields and custom field values changes in user administration e modification of user permissions e password resets and password clearance and e database migration from Access to Oracle e Account lockout events 36 Review of method parameters Each result version is associated with its ChemStation method that is stored in the relational ChemStore database To inspect the differences in method parameters between result revisions or to review a method that was used to generate a specific result the application provides direct access to the method information from the Chan Stara car intarfaca All cnickel operator Example Only See your originals shipped with the product or handed over by the Customer Engineer Lreated at 6 9 00 3 48 57 PM 6 9 00 3 48 57 PM the associated result version method name method modification date
160. cts to help facilitate information handling and security This variety allows a lab to Maintain compliance from the day software is installed through everyday use and into upgrade and service providing continued productivity with minimal downtime Design Qualification DQ is a step in the right direction The first step in any compliance program Is Design Qualification This process requires the lab to document user requirements and Agilent instrument functional opera tional specifications The instrument ven dor also has to be qualified for appropriate software development processes To assist the lab in this process Agilent utilizes an extensive list of functional specifications for computer systems that allows applica ble functions and specifications to be qualified for their intended uses Agilent also provides documented evidence that software and computer systems have been developed and validated according to standardized procedures such as ISO 9001 ChemStation Plus NDS Modular software for more control and more productivity The ChemStation family provides a modular approach to instrument control data acquisition and data management allowing a lab to choose a system that meets current and future needs To accomodate these changing needs the scalable solution starts with ChemStation base software and add on software modules that cover security and compliance to expand the system s capabilities
161. d and sequence fil installed at the time of sl delivery by an authorise ___ service provider Please contact you local Agilent Technologies representative for more details Diagnostics Early Maintenance Feedback The Agilent 1200 1100 Series LC MSD software extends the diagnosis view of the existing LC ChemStation to include tests for the Agilent 1200 1100 Series LC MSD The diagnosis view is designed to help users identify instrument malfunctions starting from a particular symptom Maintenance and repair proce dures for the Agilent 1200 1100 shipped with the product or handed over by the Customer Engineer Station includes capabilities for evaluation of mass spectral data acquired from the Agilent 1100 Series LC MSD module Both UV visible and LC MSD data can be viewed compared and printed Chromatograms from the separate detectors may be simul taneously displayed aligned and resized to correlate peaks from one chromatogram to the other Mass spectra and UV visible spectra can be simultaneously reviewed using a common spec tral toolset Reports can include either UV visible or mass spectral data or both Interactive Data Processing The data from the mass selective detector may be displayed in a number of ways The total ion chromatogram TIC is the sum mation of all mass signals m z values over the entire acquired data range An extracted ion chro matogram EIC displays the sig nals of individual ion
162. d client as well as copies of G2184AA for all Method Validation Pack clients For full support of FDA s 21 CFR Part 11 replace G2181BA with G2183AA Agilent provides all Agilent ChemStation Plus software and Oracle 9i software on Agilent CD Rom media Description Product No ChemStation Plus Method Validation Pack G2184AA Requires but does not include ChemStore C S or Security Pack Allows for method validation according to DIN ICH USP and EP guidelines Supports 21 CFR Part 11 only in conjunction with ChemStation Plus Security Pack Software module to add Agilent ChemStore C S to an existing G2181BA ChemStation for GC LC LC MSD CE or A D ChemStation Plus Security Pack G2183AA Adds the secure ChemStore C S relational database add on software module to the ChemStation Plus SW for A D GC CE LC and CE LC MSD Example Only see your originals shipped with the product i Product No or handed over by the ode G2184AA Customer Engineer owe Gye numbereematned Ds validation systems in SONNO oan i ChemStation Plus C S Must have one copy of G2186BA or G2181BA per PC running Method networked data Validation Pack software For full support of 21 CFR part 11 replace systems G2181BA with G2183AA per server NOTE The number of Method Validation clients can be smaller than the number of ChemStation plus clients in case method validation will only execute on a subset of all networked ChemStation Plus clients G1410A Qty one p
163. d directly from the ChemStation s Help menu or the Show command dialog box is the programmer s function reference It includes syntax and parameter explanations with example macros illustrating the use of commands By virtue ine the users can mples and command tly into their own e files shipped with the product or handed over by the Customer Engineer check lists to help less frequent users to deal with error conditions and set up the system correctly These checklists are directly linked to the detailed on line help information Understanding The Understanding Your ChemStation manual documents the principals of the software operation and the algorithms used in the data manipulations Customization Sophisticated users who wish to customize the operation of the ChemStation Plus tivity Guide G2170 Jes installation and reference information for imple menting an XML interface between the Agilent ChemStation and a LIMS Laboratory Information Management System The guide contains examples of the XML files and the schemas used to generate them XML eXtensible Markup Language is a protocol for structuring data in pure text format XML is a highly flexible and portable format for exchanging data between different systems Example Only See your originals shipped with the product or handed over by the Customer Engineer i a www agilent com chem cds Windows Windows 2000 and Windows XP a
164. dard deviation In addition Regression Statistics can also be used to calculate curves and statistics of two numerical columns Curve types include linear quadratic cubic logarithmic exponential power The curve parameters for the curves and the residuals will be calculated and displayed Residual z ves can also be displayed art n expressions Mathematical calculations performed on results using lt in expression definition ve figure 7 fers the basic expression ranecns addition subtraction division and multiplication plus the following functions e exponential natural logarithm logarithm square square root Po iperyl Statistics ee _ 14 0 00536 0 010 0 00955 0 0045 47 2374 0 0000 Figure 6 Summary statistics 38 57 4074 03 70 15 15 2 56547 2 58024 257133 0 0051 0 1968 0 0000 142 49 452 50 271 60 127 4384 46 9210 16240 5492 8437 11 Custom calculations Data items The ChemStore C S custom calcu avr lator provides all means to develop custom calculations that cannot be done with the simple expression builder The custom calculator user interface for development of calculation templates is shown in AT Amount figure 8 Calculation templates are Figure 7 fully versioned The modification of an existing calculation template is stored as a new t Pal Only users with th permission have a custom calcul
165. ddresses for Communication IP addresses can be stored in the non volatile RAM of the module s LAN card Depending on the LAN card it is possible to assign a fixed IP address to the Agilent 1200 1100 Series modules using either a handheld control module a mode Selecting a predefined address by DIP switch or Telnet to assign IP addresses It is possible to assign a fixed IP address to the 6890N and 6850 using the front display Additional Hardware Required for LAN Instrument Control An industry standard LAN PC card is shipped with all Agilent ChemStation 32 Bit PC bundles An instrument LAN card can also be ordered from Agilent Technologies as an option to the instrument or as an individual part Please ask your Agilent Technologies representative for details Industry standard LAN using twisted pair or c cabling e Twisted pair 10 10 twisted pair cabling connectors can be u er with an Agilent G2402A 8 port 10 100 auto sensing switch for the ability to connect one or more instrument to a PC A twisted pair crossover cable can be used to make a single connection from one PC to one instrument This configuration is only suitable for single instru ment configurations This con figuration is not supported on Agilent 1200 1100 Series LC MSD systems Example Only See your originals shipped with the product or handed over by the Customer Engineer Printers The Agilent ChemStation has been designed to
166. delete functions and other setup tasks The Agilent ChemStore C S Admin Client is a web based application that can be run from any PC on the network The Admin Client performs the following main tasks on the server database using a service running on the server Minimum length is the minimum acceptable length in characters of a password Password validity is the length of time in days over which the password remains valid Minimum password recycle is the minimum number of new unique passwords that a user must use before a password can be used again Review Client Locked by user Administrators m User PR x gt i m Initialization Instrument 1 Name Ix D D Password Database demo ChemStation Rev A 10 01 1635 Copyright Agilent Technologies 1990 2003 in Startup Macros Initializing 12 rd protection of the application re id Recovery e Schedule archive dearchive and delete operations e Modify scheduled operations e View reports detailing pending operations e Review archive and dearchive history e View information about archives runs and other objects including a list of all runs in the archive unit e Execute archive dearchive and delete operations immediately e Keep an audit trail of all archive and archive delete operations e Add and modify database con nections to offer connection to a second Oracle database Da
167. document This allows for easy data export of the complete validation report and easy modification and customization of the report document 51 ChemStation Method Validation Pack Checkpoint Planning This section lists all checkpoints with their planning options and a short explanation of their meaning Precision Precision describes the extent of conformity between results obtained during repeated use of a set analytical method under recur rent and comparable conditions Monitoring the precision records random errors Precision can be planned as precision in the true sense Or as repeatabi linearity In both cases expected values of t coefficient can be ent precision can be used the stability according and Q2B The purpose testing is to provide e how the quality of as varies with time under of a variety of environr such as temperature humidity and light and to establish a re test period for the substance and recommended storage conditions Stability according to QIA is used for proving long term stability i e that an analytical substance is stable within a given range normally for a period of 12 35 months To do so a linear regression is calculated and the extrapolated regression values as well as the extrapolated values of the confidence interval are compared against the acceptance period Stability according to Q2B is used for proving short term stability i e stability of the analytica
168. e Folsom Site 91 Blue Ravine Road Folsom CA Santa Clara Site 5301 Stevens Creek Blvd Santa Clara CA Chemical Analysis Logistics Center Americas Twin Spans Industrial Park 500 Ships Landing Way New Castle DE 19720 Pleasanton Site 6612 Owens Drive Pleasanton CA Mente L H Pierre Sall President KEMA Registered Quality The method of operation for quality certification is defined in the KEMA General Terms And Conditions For Quality And Environmental Management Systems Certifications Integral publication of this certificate is allowed KEMA Registered Quality Inc Accredited By 4377 County Line Road ANAB Chalfont PA 18914 Ph 215 997 4519 Fax 215 997 3809 CRT 001 073004 KEMAX Affiliate with the N V KEMA in the Netherlands A member of the International Network for Quality System Assessment and Certification IQNet The Quality System of Agilent Technologies Inc Life Sciences and Chemical Analysis Group Customer Support activities including Compliance Services Installation Repair and Onsite maintenance of analytical test equipment in Chromatography Spectrometry Laboratory Automation and Laboratory Information Technology equipment project consultancy and user training in the Austria Belgium Brazil Canada Denmark Finland France Germany Ireland Italy Luxemburg the Netherlands Sweden Spain Switzerland the United Kingdom and the United States Customer Sales and Support ac
169. e gration events in Data Analysis method along with newly acquired sequence data files e Online help integrated ChemStation tutorial to enable learning the software while working on your own methods and data e Enhanced utilization of high resolution monitor and avail able screen real estate For users of the Agilent 1100 1200 Series LC systems and LC software e Support for the GPC Add on software G2182BA e Direct software link to new Agilent LC Diagnostics e Interface for 3rd party LC detector drivers Introduction and full support of the new Agilent 1200 Series LC including the new Agilent 1200 For users of the GC systems and GC software e With B 02 01 a GC column data Series Rapid Resolution LC system base utility is available to trans with the following new hardware modules e Agilent 1200 Series binary pump SL G1312B e Agilent 1200 Series high perfor e Agilent 1200 Series ther ted column compartment G1316B e Agilent 1200 Series vari wavelength detector SL e improved diode array SL G1315C e improved Agilent 1200 mutliple wavelength detec G1365C Important firmware information for Agilent 1200 1100 Series sys tems e For Agilent 1200 1100 Series modules the minimum firmware revision is A 06 02 e The new G1315C G1356C DAD SL MWD SL require firmware B 01 02 e Firmware Rev A 06 02 and B 01 02 are not compatible with 6 01 resp B 01 01 or earlier fer user defin
170. e 190 950 nm Short term noise ASTM 1 x 10 AU at 254 and 750 nm See on page 52 Single and Multi Wavelengt Drift 2 x 10 3 AU hr at 254 nm See on page 52 Linear absorbance range gt 2 AU upper limit See on page 52 Wavelength accuracy 1nm Self calibration with deuterium lines verification with holmium oxide filter Wavelength bunching 1 400 nm Programmable in steps of 1 nm Slit width 1 2 4 8 16nm Programmable slit Diode width lt 1nm Flow cells Standard 13 ul volume 10 mm cell path length See Optimization and 120 bar 1760 psi pressure maximum Overview Semi Micro 5 pl volume 6 mm cell path length and 120 bar 1760 psi pressure maximum Micro 2 pl volume 3 mm cell path length and 120 bar 1760 psi pressure maximum High pressure 1 7 ul volume 6 mm cell path length and 400 bar 5880 psi pressure maximum 80 nano 0 08 ul volume 10 mm cell path length and 50 bar 725 psi pressure maximum 500 nano 0 5 ul volume 10 mm cell path length and 50 bar 725 psi pressure maximum Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 25 Performance Specifications Agilent 1200 Series DAD and MWD continued Type Control and data evaluation Analog outputs Communications Specification Comments Agilent ChemStation for LC Recorder integrator 100 mV or 1 V output range 0 001 2 AU two outputs Controller area network CAN GPIB RS 232C APG Remote r
171. e 2 2 405e 2 3 863e 2 1 738 RetTime k Area Height Symm Width Plates Resol Signal min mAU s r rise per M e Example Onl ne 1 294 0 15 309 3956 Xampie UNIV 1 2 1 732 0 53 279 8713 1 at D_3 5 445 2 05 332 1787 See your originals 50 6 659 4 D 7 sciiti shipped with the product or handed over by the Customer Engineer SSD ESS EE DE DE DE o DS a Instrument 1 24 Feb 06 5 39 25 PM Page Dn 2 5 Performance Qualification PQ Phase Customer contributed material Agilent 1200 Series Qualification Workbook 5 Performance Qualification PQ Phase Customer contributed material Agilent 1200 Series Qualification Workbook www agilent com In This Book This Qualification Workbook for the AGILENT TECHNOLOGIES 1200 Series systems and modules for LC contains documents of the 4 phases of the entire instrument life in a user s laboratory e Design Qualification DQ e Installation Qualification IQ e Operational Qualification OQ e Performance Qualification PQ Agilent Technologies 2006 Printed in Germany 02 06 G1310 903 90300 ig Agilent Technologies
172. e Agilent ChemAccess C S server which either transfers result data from the Agilent ChemStation to the server for data storage or performs remote real time plot Recommended server configurations are listed in table 7 Note For a ChemStation Plus system which has both ChemAccess and Agile ChemStore modules us Agilent ChemStore C S requirements Disk con may need to be custom to your laboratories on long term storage need Server software requirements e Windows NT 4 0 with Service Pack 6a or Windows 2000 Service Pack 2 e Microsoft TCP IP networking supplied with Windows NT and Windows 2000 Entry level Number of clients supported 1 10 Agilent NetServer model or equivalient LC2000 Processor speed MHz 933 Number of processors 1 Example Only see your originals shipped with the product or handed over by the Customer Engineer Hi end 1 15 LH3000 1 GHz 1 512 MB 2 x 18 GB 3 x 18 GB one and five yes 1 aemAccess C S Agilent ChemAccess C S Product Options and Configurations The complete Agilent ChemAccess C S software is provided on the Agilent ChemStation Plus CD ROM This includes the software listed in table 8 Description ChemAccess server software for remote status monitoring and control of 16 bit ChemStation Includes 10 user licenses for 3D data analysis software and a 2 user license for the GC MS data analysis software ChemAccess client software 5 user license rem
173. e from 4 C to 40 C in 1 increments Temperature accuracy at ambient 1 C to 4 C ata setpoint of 4 C temperatures lt 25 C and humidity lt 50 Temperature accuracy at ambient 1 C to 5 C at a setpoint of 4 C temperatures gt 25 C and or humidity gt 50 Physical Specifications Table 50 Physical Specifications Thermostatted Autosampler Type Specification Comments Thermostat Weight 20 7 kg 45 6 Ibs Dimensions 140 x 345 x 435 mm height x width x depth 5 5 x 13 5 x 17 inches Line voltage 100 120 or 220 240 VAC 10 Automatic selection Line frequency 50 or 60 Hz 5 Power consumption Autosampler 300 VA Maximum ALS Thermostat 260 VA Maximum Ambient operating 4 40 C 41 131 F see User manual temperature Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 50 Physical Specifications continued Thermostatted Autosampler continued Type Specification Comments Non operating altitude Up to 4600 m 14950 ft For storing the autosampler Safety standards IEC CSA Installation Category II Pollution UL EN Degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Agilent ChemStation Specifications Agilent 1200 Series Qualification Workbook e Agi
174. e sum mary The statistical reports may be selected as standard or extended styles The Standard Style is text based and includes the mean standard deviation SD relative standard deviation RSD and standard error for the following parameters tabulated by com pound e retention time e area e height e peak width and e peak symmetry The Extended Style includes graphical trend analyses based on a selection of parameters for sta tistical evaluation The parameters that can be selected include e retention time area height amount peak width at half height by the sigma tangent and tailing meth ods peak symmetry tailing factor capacity factor k F theoretical plates by the y width at half height sign gent and statistic methoc resolution by the peak wi half height sigma tanger statistic methods e selectivity e skew and excess Technique specific parametc sxox liquid chromatography include e peak purity evaluation factors with the diode array spectral evaluation module only and e spectral library comparison fac tor with the diode array spec tral evaluation module only The report includes a separate graphical trend analysis for each selected parameter Sequence summary reports may be output to the printer to file or both The user may select to either print or suppress individual analysis reports together with the sequence Summary Customized Reports
175. e user may automati a selected parameter of d each time a method Je parameters include Amou ivesponse Factor Retention Time and Area DDE standard of the Microsoft Windows platform as both a DDE client and a DDE server The com mand set includes commands to establish and terminate connec tions transfer information in both directions and execute remote functions Data Analysis Integration All files data files methods sequences log files etc created on previous ChemStation Rev A xx xx systems can be loaded and used in the new 32 Bit Rev B 01 0x ChemStation The Rev B 01 0x system converts Rev A xx xx files to a new structure during saving The new structure XML Interface j XML eXtensible Mark Language is a protocc turing data in pure tex XML file contains data embedded structural i and being pure text Il ed with a simple edito Notepad XML has bec flexible and portable format espe cially for exchanging data between different systems Customization The ChemStation can be custom ized using a powerful command set These commands may be grouped to automatically execute a specific function such a group is called a macro Users writing macros may define their own vari ables build in conditional or loop ing constructs perform physical VO including file handling and is not compatible for use with older Rev A xx xx or B 01 0x sys tems The system will warn users to save files with a new
176. e vial Typically lt 0 5 RSD of peak areas from 5 2000 ui Typically lt 1 RSD of peak areas from 2000 5000 ul Typically lt 3 RSD of peak areas from 1 5 pl 1 ul from 5 pl sample in 100 pl microvial or 1 pl from 10 pl sample in 300 ul microvial Typically lt 0 1 lt 0 05 with external needle cleaning 0 2 50 cp 100 x 2 ml vials in 1 tray 40 x 2 ml vials in tray 15 x 6 ml vials in tray Agilent vials only Typically 50 s depending on draw speed and injection volume Design Qualification DQ Phase Physical Specifications Table 18 Physical Specifications Autosampler G1329A G2260A Type Specification Comments 14 2 kg 31 3 Ibs Weight Dimensions height x width x depth 200 x 345 x 435 mm 8 x 13 5 x 17 inches 100 120 or 220 240 VAC 10 Line voltage Line frequency Power consumption apparent power Power consumption active power 50 or 60 Hz 5 300 VA 200 W Wide ranging capability Maximum Maximum 4 55 C 41 131 F Ambient operating temperature Ambient non operating temperature Humidity Operating Altitude Non operating altitude Safety standards IEC CSA UL 40 to 70 C 4 to 158 F lt 95 at 25 40 C 77 104 F Up to 2000 m 6500 ft Up to 4600 m 14950 ft Installation Category Il Pollution Degree 2 For inddor use only see User Manual Non condensing For storing the autosampler
177. e well Then it will slowly move upwards while the fraction is collected The contact control mode enables the micro collector spotter to collect fractions down to 2 ul in well plates or MALDI spots down to 100 nl 4well plates full tray MTP with 384 or 96 well plates standard and conical shape or 4 x 27 Eppendorf tubes 0 5 1 5 2 0 ml MALDI Target Plates e 2x well plates std tray MTP 10 x 2 ml vials 1 half tray with 384 or 96 well plates standard and conical shape or 2x 27 eppendorf tubes 0 5 1 5 2 0 ml 96 Agilent plate for AP MALDI e 100 Applied Biosystems 2x96 Applied Biosystems 192 Applied Biosystems 400 Perseptive Biosystems Micromass 80 96 spots e Bruker Anchor Chips 384 1536 spots 4 3 for Bruker Anchor Chip 1536 Typically 2 ul depending on the fraction collection container 100 5000 nl depending on the MALDI plate 20 spots min 1spot 3s 100 ul min Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 34 Performance Specifications Agilent 1200 Series Micro Autosampler G1364D continued Type delay volumes ul cooling maximum capacity GLP features interfaces Specification 25 um ID fraction collector capillary 0 25 50 um ID fraction collector capillary 1 100 um ID fraction collector capillary 5 Recommended with additional G1330B 2 micro collector spotter connected via 2 Position 6 Port micro valve G1162A
178. each other 66 Non Agilent software e MDAC 2 8 Microsoft Data Access Components 2 8 installed by ChemStore e Adobe Acrobat Reader 5 0 part of standard bundle e Microsoft Internet Explorer 6 0 The Microsoft Data Access Components install a layer to access local databases or central database servers Method Validation Pack uses Microsoft IET database ta save local data Example Only See your originals shipped with the product or handed over by the Customer Engineer other ChemStation Plus modules as outlined above are also user installable for advanced users However Agilent recommends the installation of the ChemStation Plus modules through an Agilent certified service engineer to prevent from any potential installation problems and for inclusion of software familiarization upon installation Client server installation The client server installation must include for the server e installation of Oracle 9i server software version 9 2 0 3 0 e installation of ChemStore server software e creation of the Oracle database e installation of Method Validation Pack software and e creation of Method Validation Pack tablespaces in ChemStore Oracle instance alias HPCS very client the procedure les the installation of acle 9i client software ver n 9 2 0 3 0 emStation software for data juisition emStore or Security Pack tware for data management thod Validation Pack software Piease note that Method
179. eady start stop and shut down signals LAN optional Safety and maintenance GLP features Housing Extensive diagnostics error detection and display through control module and ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas Early maintenance feedback EMF for continuous tracking of instrument usage in terms of lamp burn time with user settable limits and feedback messages Electronic records of maintenance and errors Verification of wavelength accuracy with built in holmium oxide filter All materials recyclable ASTM Standard Practice for Variable Wavelength Photometric Detectors Used in Liquid Chromatography Reference conditions cell path length 10 mm response time 2 s flow 1 ml min LC grade Methanol slit width 4 nm Linearity measured with caffeine at 265 nm For environmental conditions refer to Environment in the User Manual Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Physical Specifications Table 26 Physical Specifications Type Specification Comments Weight 11 5 kg 26 Ibs Dimensions 345 x 435 x 140 mm width x depth x height 13 5 x 17 x 5 5 inches Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60Hzt 5 Power consumption 300 VA 125 W 427 BTU Maximum G1315B 65B Ambient operating temperature 0 55
180. ector s time table The ChemStation includes a diagnosis screen for testing the reference and sample photo diode light paths in the detector The FPD is interfaced to the ChemStation through the digi tal GP IB interface for control and through a dual channel A D inter face for the data acquisition 27 The excitation and emission wave lengths of the HP 1046A Fluorescence Detector FLD can be set from 190 to 800nm in steps of Inm Gain response time gate delay and lamp frequency may also be set Gain and changes in the emission and excitation wave length may be time programmed The excitation and emission wave lengths may be optimized by ana lyzing scans The range and speed may be specified for each scan during the optimization process The scans taken during an analy sis are stored in a Chem spectral file format that them to be displayed an spectral library The HP 1049A Electrocl Detector ECD may be amperometry pre treatn sweep pulse and differe mode The voltage pote limits may be defined be 2 0V and 2 0V in steps Gs u 0u0rv A voltage potential increment between analysis may be defined from 2 0V and 2 0V in steps of 0 001V and the number of repeat analyses at a given increment may be set Drift limits for the detec tor not ready condition may be specified from 0 1 nA to 500 nA in steps of 0 1 nA The user may also specify auto zero control based on the prepare or stop signal or a user defi
181. ed GC columns after an upgrade from G2070AA to G2070BA ChemStation The utility is available on the ChemStation CD ROM in the 5 On nn nant AS re to sex Example Only See your originals shipped with the product or handed over by the Customer Engineer Table of Contents Wildl s NEW IN AU a a en ea readers eue ct de dor cou 1 General Description 2235444 eesmisesanssnarasnnesrsotestuemeseatsecrasvusen 4 Computer HardWare ssi 6 Minimum PC Configuration 6 Maximum Number of Supported Instruments 7 cr us e i 7 Ly 8 Example Only 1 8 i EE senwan sae E 9 See your originals io shipped with the product E NTE E i or handed over by the liana salare 11 GG 5 ARRESTARE 11 Customer Engineer 1 j Data ANalySIS DISPIAY I E 14 Data Analysis Integration 15 Data Analysis Quantification 15 Data Analysis Standard Reporting 17 Data Analysis Specialized Reporting 18 Utilies and Compatibilities 19 ANU IMEN ACG sats arane greece E I awe ire 20 GUSLOMIZATION siii reali pei 20 AULOMAUO a a 21 Good Laboratory Practice 22
182. ed Validation closed Upward 1 13 2004 5 04 50 PM Administratc 1 Saved Validation opened MI 1 13 2004 5 05 33 PM Administratc 3 Unsaved Stability long term Standard Checkpoint copied from va MD 1 13 2004 5 05 33 PM Administratc 3 Unsaved Stability long term Upward Checkpoint copied from va 1 13 2004 5 05 33 PM Administrate 3 Unsaved Stability long term MI Checkpoint copied from va Administratc 3 Unsaved Stability long term MD Checkpoint copied from va Three levels of audit trail with Method Validation Pack software Method Yalidation Pack User Cnickel Chr nickel local login Demonstration Substance Audit Log le Lx Example Only See your originals shipped with the product or handed over by the Customer Engineer Kepo 1 UU C1 10 11 1 unsaved settings 12 2 2002 21 19 26 3 Unsaved CS 12 2 2002 21 29 25 1 Unsaved 14 2 2002 00 04 28 1 Saved 14 2 2002 00 07 12 1 Unsaved Template 14 2 2002 00 17 59 1 Unsaved wizard 14 2 2002 00 18 01 1 Unsaved 19 2 2002 12 05 27 1 Saved 19 2 2002 13 24 52 1 Saved 19 2 2002 13 48 39 1 Saved 19 2 2002 14 33 28 1 Saved 19 2 2002 14 45 05 3 Saved 13 3 2002 10 38 16 1 Saved 13 3 2002 15 23 21 1 Saved 19 2 2002 12 05 48 1 Saved 19 2 2002 12 05 48 3 Saved 19 2 2002 12 06 10 1 Saved 19 2 2002 12 09 55 1 Unsaved Loaded Fox A Start 4DMS Server local IE Method Validation Pa 27 auditing submenu_marked Figure 53
183. ed and Manual _Setup report using Specify eport menu rint an area percent report emonstrate reviewing and reprocessing of data files sing the navigation table in ata Analysis itification oad method DEF_LC M Joad data file ISOCRA D Demonstrate the steps in creating a single level calibration Demonstrate generating a External Standards report Spectral Data Evaluation Q Section Not Applicable O Demonstrate display of spectra and reference spectra Q Demonstrate display of a 3D plot Q Demonstrate display of an Iso absorbance plot Q Demonstrate the creation of a Spectral Library Q Demonstrate creation of an Automated Library Search Report WAD Product Support Page 2 of 3 Agilent 1200 Series Liquid Chromatograph Familiarization Checklist E Demonstrate Peak Purity Purification and Fraction Collection Q Q Section Not Applicable Demonstrate how to reset the tray fill information Demonstrate how to perform a delay calibration Demonstrate fraction collection in the time based and peak based mode Demonstrate the use of the Fraction Preview Demonstrate the Fraction collection in a single Diagnostic Q Explain file management and other software utilities Q Describe the importance of data back up disk checks disk de fragmentation archiving and master disk storage Q Discuss the importance of disabling power management options and utilities that run
184. ed to represent signal intensity Users can define the contour color schemes and retention time and m z ranges for the display Acquired mass spectra can also be displayed as a three dimensional plot of m z against retention time and abundance The display can be graphically adjusted by the user in the time m z and intensity domains The resolution of the plot is selectable and the orienta tion of the plot can be adjusted graphically The plot may be print ed and the color scheme adjusted Agilent 1200 Chip Cube Interface G4240A The Agilent 1200 Chip Cube inter face is designed for LC systems gt sing an Agilent Ion Trap MSD as etector and Bruker Software for ata Analysis The ChemStation rovides software support for this iterface Agilent ChemStation for A D Acquisition with the Agilent The user may also define the units ChemStation for A D for acquisition and their relation G2072BA and the Additional ship to the voltage signal AID Instrument Module G2073BA units volt The Agilent 35900E interfaces offer external event control through digital TTL The A D ChemStation and addi transistor transistor logic signals tional A D interface acquisition each of which are given specific module controls and acquires data state high and low names that from Agilent 35900E dual channel may be time programmed before interface These interfaces allow during and after an analvsis The the ChemStation tu fr
185. ed using LAN Q Use the Configuration Editor and configure your instruments Q Install the Agilent LC Diagnostic software configure Agilent Bootp Service for LAN connection Use the Configuration Editor and configure your instruments Install and Configure Software Add Ons if applicable If present install the PC Image software and create a backup using the Backup Solution User Guide as reference If present install the Agilent LC Diagnostic software Issued Feb 2006 Rev 6 0 Copyright 1995 Agilent Technologies Service if the instrument will be yee Agilent Technologies e 1200 LC Checkout Q Start arun Q Prepare 1 pump s 2 online degasser s if present 3 injection device s 4 column compartment 5 detector s 6 fraction collector s 8 if present Valve s if present recording device LJ Attach results to installation documentation Fill out instrument logbook Verify c onnection to the Agilent LC Diagnostic Tool WAD Product Support Page 5 of 6 Agilent 1200 Series i Liquid Chromatograph Hardware and Software Installation Checklist Service Review Note Password 1s the Registration O Affix any reports generated to number for the software this Checklist Q Record in the instrument logbook date and time install was completed Q Explain Agilent warranty for Hardware Software and return policy for the Instrument Service Center Q Explai
186. elected entry Baseline drawn manually Automatic transfer from batch after detecting different results or d Custom fie alues Man Integ Details Figure 21 Area Difference in Peak 1 02 min Last value was 0 7 Amount Difference in Compound 1 02 min Last value was 0 092591 Current value is 0 091928 Modified data have been set as reference ChemStore is updated List of integration events history for signal DAD1 A Sig 254 4 Ref 550 100 Event No 1 Time Start 0 942071 min Abs Start 0 116093 mAU offset from chromatogram at begin peak Time End 1 191617 min Abs End 0 000818 m amp U offset from chromatogram at end peak Command Draw Baseline Manual integration events documented in ChemStore run audit trail example in an audit situation see also the application note Handling of Electronic records with ChemStation Plus publication number 5988 9643EN which is available under a confidentiality agreement l ChemStation Plus Security Pack Graphical Result Review and Calculation Summary of version manage ment in the ChemStation Plus Security Pack Each time a new result is calculat ed in the ChemStation the appli cation compares the values with the result values of the last reprocessed result copy If it detects a difference it automati cally initializes the data storage in the database Each data transfer of new results creates a new ver sion entry in the da
187. emStation Software Modules G2070BA G2071BA G2072BA G2073BA G2170BA G2171BA G2180BA G2090BA G2710BA G1601BA G2201BA B 02 01 Upgrade Site Preparation Checklist Installation Qualification Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist Agilent LC and CE ChemStation Software G2170BA G2171BA G21 5BA G2180BA G2185BA G211601BA G2172BA G2205BA Software Installation Checklist B 02 0x Familiarization Checklist Agilent 1200 Series Liquid Chromatograph Famliarization Checklist Agilent 1200 Series Liquid Chromatograph Scorp of Work Installation and Famliarization Declaration of Conformity and System Validation Declaration of Conformity According to ISO IEC Guide 22 and CEN CENELEC EN 45014 Declaration of Conformity to mannufacturing Specifications ChemStation Declaration of System Validation ChemStation Installation Verification Report Customer contributed documents fhe Agilent Technologies 3 Installation Qualification 10 Phase For the items marked with a example pages are added It is the responsibility of the user to replace these with the originals The user should feel free to add further documents e g not supplied by Agilent Technologies whenever he thinks this is appropriate Agilent 1200 Series Qualification Workbook Installation Qualification I0 Phase 3 Side Preparation Specification Checklist Agilent 1200 Series Qualification Workbook 3 Installation Qualification
188. ems such as columns vials syringes solvents and buffers required for the successful installation of instruments and systems are available Installation sites should be prepared in i accordance with the following specifications An Agilent custo engineer will call approximately weeks prior to installation to conf site readiness Important Information This checklist is designed to be u in conjunction with the Agilent 1 4 Series LC MSD Site Preparation Manual If you have problems providing any of the following please contact your local Agilent sales office for assistance Assistance with user specific applications may be provided but should be contracted separately Users of the instrument should be present throughout the installation and familiarization otherwise important operational maintenance and safety information may be missed Issued Feb 2006 Rev 2 0 Procedure Checklist Agilent G1956A B Mainframe Tick Boxes fj footprint Depth 62 3cm Width 64 0 cm 24 5 in 25 2 in 4 maximum cabinet dimensions Weight 63 1 kg Height 57 5 cm 138 75 1b 22 6 in Depth 68 83 cm Width 73 0 cm 27 1 in 28 75 in d E1M18 Mechanical Pump Weight 32 0kg Height 23 cm 70 4 Ib 9 2 in O Example Only see your originals shipped with the product _ or handed over by the Customer Engineer Depth 95cm Width 18 0 cm 3 7 in 7 1 in d Agilent G1971A APPI Source Weight 1 7 kg Height 23 cm 3 75 Ib 9 2 i
189. ent shall control Technology Licenses The hardware and or software described in this document are furnished under a license and may be used or copied only in accor dance with the terms of such license Restricted Rights Legend If software is for use in the performance of a U S Government prime contract or subcon tract Software is delivered and licensed as Commercial computer software as defined in DFAR 252 227 7014 June 1995 orasa commercial item as defined in FAR 2 101 a or as Restricted computer soft ware as defined in FAR 52 227 19 June 1987 or any equivalent agency regulation or contract clause Use duplication or disclo sure of Software is subject to Agilent Tech nologies standard commercial license terms and non DOD Departments and Agencies of the U S Government will receive no greater than Restricted Rights as defined in FAR 52 227 19 c 1 2 June 1987 U S Government users will receive no greater than Limited Rights as defined in FAR 52 227 14 June 1987 or DFAR 252 227 7015 b 2 November 1995 as applicable in any technical data Safety Notices CAUTION A CAUTION notice denotes a haz ard It calls attention to an operat ing procedure practice or the like that if not correctly performed or adhered to could result in damage to the product or loss of important data Do not proceed beyond a CAUTION notice until the indicated conditions are fully understood and met
190. enu item to select the desired batch from the pool of pending Agilent ChemStore C S batches to download the runs to the Agilent ChemStation The operator then reviews the data in the ChemStation batch review and makes the necessary changes After completion of the review the modifications can be transferred to the database as new result versions 2 Task flow in the review client Retrieve and review sample Injection datetime 10 6 94 6 19 19 P Control PABS WADPC155 10 6 94 6 28 17 P Control Procaine WADPC135 F 1076794 6 38 07 F Procaine decay WADPC135 k 10 6 34 8 18 22P Procaine decay WW amp DPC135 10 6 94 10 18 25 Procaine decay WAD PC135 JA 10 7 94 1218 21 Procaine decay WADPCT 35 JA 1077794 2 18 20 4 Frocaine decay l WBDPC1 35 Ji 10 7 94 4 18 20 A Control PABS WADPCI 35 Ji 10 7294 420014 4 Control Procaine WADPCI 35 Ii 10 7434 4 38 04 A Procaine de decay l WBDPC1 35 JA 10 7794 6 18 25 Procaine decay WAD PC135 5 f 1077794 5 18 25 A Frocaine decay WADPC135 1077794 10 14 18 Injection date time Procaine decay 10 6 94 12 10 27 Procaine decay 10 6 94 2 18 21 Al Procaine decay 10 6 94 4 4 18 24 Al Procaine decay 10 6 94 6 18 20 Al Procaine decay 10 6 94 9 18 24 Al Control PABS 10 6 94 8 28 18 Al Control Procaine 10 6 94 8 38 13 Al Procaine c decay ie 10 18 17 Procaine decay 10 6 94 12 1
191. er WAD Product Support Agilent Technologies O Replace rotor seal O Replace the needle and the needle seat assembly Q Clean the transport unit rods using a lint free cloth and IPA DON T use any lubricant for the transport unit rods Q Check that the ALS Thermostat unit drain tube is positioned correctly if applicable O Purge Autosampler and Column Compartment with IPA for 5 minutes rite Column Compartment tains a Column Switching ye Cap outlet of ALS with k nut Otherwise Cap outlet of imn Compartment with king nut orm built in pressure test t Pass Fail Pass Fail Z Result G1328B Manual Injector 5065 9922 Prep Manual Injector O 1 Record model number Q 1 Record serial number QO Replace rotor seal Purge Injector and Column Compartment with IPA for 5 minutes Q Ifthe Column Compartment contains a Column Switching Valve Cap outlet of Injector with blank nut Otherwise Cap outlet of Column Compartment with Page 2 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist blanking nut Column Compartment with O Perform built in pressure test blanking nut Q Perform Pressure Test Result Pass Fail G1367B High Performance 1 Result Pass Fail Autosampler G1377A Micro Well PI Sampler 2 Result Pass Fail G2258A Dual Loop Autosampler LUM O 1 Record model number COLUMN UMN Example Only Q 1 Record serial numb See VOUT origin als shipped with the product
192. er Engineer presentation is available only if no e CSV format for spreadsheet applications e XML format as generic file interface excluding graphics nary or regression Statistics a use If regression statistics eing calculated the regres chart and residual chart pre tions replace it Figure 11 is Jrample of a chart contained in the display area Retention time reproducibility 100 runs six days Upper siilival line RT P vvar J Lower warring line IRT P Upper waning line RTL A vedin J Lower critica line RT P i 50 0 run number Figure 11 Chart for retention time reproducibility with warning and critical limits 15 Agilent ChemStore C S Security Data acquisition data analysis and data review are password protected Each user must have a valid user id and a password to log on to the application as shown in figure 12 To be able to transfer data to the database the user must be logged on to the database User validation is done on a per database level and always requires to enter a user name and a password Permissions for several tasks like approval or archival of runs creation of custom fields report templates calculation templates or studies can be assigned to each individual user Four user group templates for permission rights are supplied wi client They can be us starting point for the of the permissions Ni and their security per configured separately Agilent
193. er server ChemStore C S server application software Includes ChemStore C S server software Oracle 8i standard edition software 5 Oracle application specific named user licenses G1411A Qty Required for each named user in the ChemStation Plus networked data system 5 Oracle named user license for Agilent NDS Required for each named user of the ChemStore C S server database G2181BA Qty one per server ChemStore C S client application software Software module to add Agilent ChemStore C S to an existing ChemStation for GC LC LC MSD CE CE MSD or A D ChemStation Plus ChemStore client license G2186BA Includes one online ChemStation Plus license for online data acquisition Oty Number of clients and one ChemStore C S offline data review license Includes 1 license and user information only Requires but does not include ChemStation Plus software client media G2183AA Qty one per server Replaces G2181BA ChemStation Plus Security Pack Adds the secure ChemStore C S relational database add on software module to the ChemStation Plus software for A D GC CE LC and CE LC MSD Supports 21 CFR Part 11 67 Installation Qualification Services and Training Installation and familiarization Agilent Technologies installation and familiarization service ensures that the Agilent ChemStation Plus is installed correctly and in the right environment In addition Agilent offers a range of on going support services to
194. eration of the instrument 3 The IQ phase is finished after the successful installation and the signing of the Installation Qualification Protocols by a trained representative of AGILENT TECHNOLOGIES and the customer Who performs installation qualification IQ for large complex instruments as liquid chromatographs should be performed by vendors Only for small low cost instruments such as pH meters IQ can be performed by users The AGILENT TECHNOLOGIES 1200 Series concept The process is broken into e Installation Qualification for Hardware The installation follows a documented procedure The equipment is checked for completeness and proper function after installation AGILENT TECHNOLOGIES provides field proven protocols for Installation Qualification IQ which is followed filled out and signed by a trained AGILENT TECHNOLOGIES representative during an installation For a system that consists of several modules IQ includes an injection and qualitative evaluation of the isocratic standard sample which verifies the correct installation of all fluid and electrical tubing and cables e Installation Qualification for software and computer systems The installation of software follows a documented procedure Installation of software on a computer is checked for integrity AGILENT TECHNOLOGIES provides installation qualification software for integrity check of the AGILENT TECHNOLOGIES ChemStation software which is executed during insta
195. erent injection volumes the speed of injection and the injector wash procedure The user may also spe cify a complete injector program for sample dilution standard addi tion or sample derivatization The commands available for the injec tor program include draw eject mix wait inject sampler valve and column switch control These can be defined in conjunction with the sample a vial well plate 26 offset from the sample a numbe red vial well waste and air The Agilent bar code reader G2256A is available for selected autosampler configurations It can be used to help build automation sequences and verify the identity of the injected sample matches the name in the sequence table at injection time In LC configura tions it can also be used to mix liq uid samples as a step in an injec tion program The following Agilent 1200 1100 Example Only see your originals shipped with the product or handed over by the Customer Engineer G1367B e Well plate autosampler G1367A e Thermostatted well plate autosampler G1368A e Micro well plate autosampler G1377A with illumination e Thermostatted micro well plate sampler G1378A e Thermostatted micro autosam pler G1387A Preparative autosampler G2260A with illumination e Thermostatted preparative sampler G2261A e Agilent sample capacity extension G2257A for the 1100 Series well plate sampler G1367A and micro well plate sampler G1377A e Ag
196. es and the AGILENT TECHNOLOGIES ChemStation which demonstrate that the equipment functions according to operational specifications The documents must be updated by the user whenever tests have been performed Performance Qualification PQ Phase Definition and frequency Performance qualification is the process of demonstrating that an instrument consistently performs according to a specification appropriate for its routine use 3 Agilent 1200 Series Qualification Workbook 1 Overview The test frequency every day every month or whenever the instrument is used is much higher than for OQ It depends not only on the stability of the equipment but on everything in the system that may contribute to the analytical results e g column and detector lamp The test criteria and frequency should be determined during the development and validation of the AGILENT TECHNOLOGIESLC method Another difference is that PQ always should be performed under conditions that are the same or similar to routine sample analysis Who does performance qualification PQ always should be performed by users because it is application specific and vendors may be unfamiliar with the applications The AGILENT TECHNOLOGIES 1200 Series concept Intelligent system suitability check The AGILENT TECHNOLOGIES ChemStation includes intelligent system suitability testing in which users measure and compare critical key system performance characteristics with d
197. es that are part of the system and fill in the corresponding Serial Number Issued Feb 2006 Rev 6 0 Unpacking and inspection of shipped materials Note Shipping containers should not be opened until an Agilent Technologies representative is present LY Unpack all boxes and place equipment on bench To prevent injury get lifting assistance if needed Q Retain shipping containers and material until installation is complete and performance is verified 1 Natifu ardar fulfillmant nf anw Example Only See vour originals shipped with the product or handed over by the Customer Engineer Q When applicable install computer system and connect all power interconnect cables Q Check for the Agilent LC Diagnostic CD ROM and install this software component Copyright 1995 Agilent Technologies WAD Product Support yee Agilent Technologies e G1322A 79B Degasser Q Section NOT Applicable 1 SN FW 2 SN FW Set up the degasser s solvent inlet outlet Priming each channel with Isopropanol from solvent bottle to pump inlet Dow G1310A 11A 12A Pump Q Section NOT Applicable EW IFW EW et up the pump s solvent inlet outlet waste drain remote control if used O relay contacts if installed O seal wash tubing 1f installed o CAN O Agilent LAN see note Q Priming the pump O prepare solvents turn on purge purge mobile phase monitor the pressure O O O O G13
198. esult management in a relational database Method Validation Pack offers a compound centric design For each Checkpoint planning on page 49 e Partial execution of validation sequences see ChemStation Plus Method Validation Pack e Calculation formula documented e Unlocking of locked validations with an electronic signature see ChemStation Plus Method Agilent ChemStation Plus Method compound it allows to define a set of tests checkpoints according to ICH Pharmacopoeia or DIN guidelines By default each test requires results of at least six repetitive injections in order to use statistics for a quantitative result evaluation In some areas less than six values can be used but then some statistical evaluation methods are omitted The statistical results can visualize whether the analytical results meet their specifications or show any deviation When all tests s ed the compound meets the ments When all compounds e requirements the method seen as applicable or vali ccording to its well defined gt and with the specified t this stage the validation ocked the full validation is and the validation study for hod can be archived Validation Pack provides all required statistical functions and calculations stores all results with their raw and meta data displays the statistical results graphically and captures all actions in automatic user independent audit trails Further it allows to map the key ste
199. evision System o y O Module Model o _____ Serial Firmware Revision System o SOSY Module Model o Serial Firmware Revision System o Module Model o ______ Serial Firmware Revision System LO LO V UOISIASEH LL 900C 0 C0 SADE 5 JOQUINN JUBWINDOG 01U09 abueyI Ag asp 404 uoneoiijeno UOI EDIIENH UOI EDIJIENH panoJddy Jo Synsay JO uoseoy Jo sjie19qg abueyy jo sjiejag Agilent 1200 Agilent 1200 Series Qualification Workbook 000 ee 1 Ogee Overview amp Introduction Agilent s line of proven qualification products and services This chapter gives you a short introduction to this workbook Fip Agilent Technologies 1 Overview Introduction Proper functioning and performance of equipment plays a major role in obtaining consistency reliability and accuracy of analytical data Therefore equipment qualification should be part of any good analytical practice 1 The term qualification as previously applied for qualification of computer systems by the U S Pharmaceutical Manufactures Association has been broken down by Freeman and coworkers 2 into four areas which describe the entire life of the equipment Design qualification DQ for setting functional and performance specifications operational specifications e Installation qualification IQ for performing and documenting the installation
200. ew result is calculat ware automatically c new run result with t result in the register results changed the rare detects the difference between the most recent and the current result and creates a new result version For proper documentation of the changes the application software creates a second file in a human readable format that stores the results of the comparison and documents the changes The file is named sec_trac txt and is stored along with the raw data in the d subdirectory as shown in figure 20 Both the registry and the text file are also stored in the database along with the raw data and they can be restored to disk with the data file if necessary These changes including manual integration events are also docu mented in the Manual Integration Events section of the ChemStore audit trail as shown in figure 21 The audit trail as well as the sec_trac txt can be used in order to regenerate the result from raw and meta data at any time for sec_Trac txt Notepad File Edit Search Help Bi Start of compare 6 8 66 Operator cnickel Datafile 665 6162 D 12 29 24 PM Compare of Signal DADI A Sig 254 4 Ref 556 166 Calib Peak Dimethylphthalate at ExpRT 6 7476 not found Calib Peak Diethylphthalate at ExpRT 1 6219 not found Peak with RT 3 4363 not found in previous results Modified data have been set as reference ChemStore is updated Calib Peak Dimethylphthalate at ExpRT 6 7476 not found
201. extended to allow for multiple instrument systems by purchasing CE Instrument data Acquisition and ation module d on software G2201BA for G1946X e Additional 35900E Analog to Digital Converter A D Instrument Control and Data Acquisition software G2073BA ChemStation License to use software on another PC Once an initial core ChemStation software product has been pur chased it is possible to purchase licenses to use that software on another PC The available license products are e License to use 2D LC ChemStation software on another PC G2175BA e License to use 3D LC ChemStation software on another PC G2185BA e License to use GC ChemStation software on another PC G2075BA e License to use CE ChemStation software on another PC G2205BA e License to use A D ChemStation software on another PC G2077BA ChemStation Data Analysis Only Software There are three data ChemStation softwa These products are data evaluation only example in an office and should not have configured The thre sis only software prc e ChemStation Data ATTY DIS software for LC G2190BA e ChemStation Data Analysis software for GC G2090BA e ChemStation Data Analysis software for LC MSD G2730BA ChemStation Plus Add On Software Modules Agilent provides a range of add on software modules which extend the capabilities of the Chem Station base software The modu lar architecture ensures that you can control y
202. f one peak splitting a peak and integrating manually with a negative baseline Access to tasks with a user dependent creation of new results is the only difference in the result management between the ChemStation Security Pack manager level and the ChemStation xt operator level Ut version in the 1e same for both id user dependent shipped with the product or handed over by the Customer Engineer J Chromatograms M Spectra for Quantified Peaks MW Sequence N Method V RawData V Delete raw data from file system after transferring to database Cancel Help Figure 18 Default configuration of data storage in database 3 Instrument 1 offline 1 Data Analysis cnickel File Graphics Integration Calibration Report Batch a Chemotore 005 0105 0 Data Analysis aja Figure 19 Manual revision management TIA View Abort Help Setup Custom Field Values me Trans fer Data to Databas e Single Aur User independent automated result version management The data storage includes an application controlled version management that is based on the creation of a result reference file Prior to reprocessing the applica tion software creates a binary result registry file called save_sec reg for each file This save_sec register is si with the raw data It numeric results of th result revision in a bi such as amount com tion time and so on n
203. ft Windows operating environments Core ChemStation 2D Software Five core 32 Bit ChemStation 2D software products are available Each core software product pro vides data acquisition instrument control data analysis integration quantification and reporting automation and customization for a single analytical instrument A single instrument may collect data from a number of different detec tors simultaneously The fivecore 2D software products are e Agilent 32 Bit ChemStation for 2D Liquid Chromatography LC systems G2170BA e Agilent 32 Bit ChemStation for Example Only see your originals additional instrument control soft ware It is possible to configure up to four chromatography instru ments per ChemStation PC The four additional instrument control software products are e Additional LC Instrument Control and Data Acquisition software G2171BA e Additional GC Instrument nd Data Acquisition G2071BA LC MS Instrument ata Acquisition and ation software shipped with the product or handed over by the Customer Engineer Converter A D systems G2072BA ChemStation 3D Software Module The capabilities of the core 2D LC software may be expanded to allow for 3D data through the pur chase of the additional LC 3D Spectral Module G2180BA ChemStation Additional Instrument Control Software The instrument control capabili ties of the core Agilent ChemStation software may be
204. g Concept of ChemStation Data Demonstrate mouse actions in the various tables and graphic items Explain Full Short menu and view structures Explain the user access levels Configure Instruments Where necessary e g for samplers and fraction collectors used trays and vessels E Configure wellplates and test tubes 1f applicable For fraction collectors only Q Configure delay volume Issued Feb 2006 Rev 4 0 See your originals shipped with the product or handed over by the Customer Engineer Q Demonstrate status monitors and on line signal display Edit Sequence Q Load sequence DEF_LC S Q Explain usage of the sequence preferences Q Explain how to create sequence templates and demonstrate the data storage based on this definition Q Demonstrate preparation of a sequence using the Sequence Parameters and Sequence Table menus Q Runa single injection sequence using the checkout sample Q Demonstrate Partial sequence and Sequence Save Copyright 1995 Agilent Technologies yee Agilent Technologies e Data Analysis n O LI Demonstrate use of the navigation pane Explain navigation table and demonstrate table options Demonstrate the various ways to load a signal and how to get signal specific information Load data file ISOCRA D found in X CHEM32 1 DATA DEMO Manipulate graphics windows Zoom print window etc Integrate signal Automat
205. g section 13 Agilent ChemStore C S Reporting Agilent ChemStore C S offers a powerful report generator The following are key customizable features of the reporting enabling users to easily create and generate final summary reports The preview function helps to interactively develop the desired report without requiring test print outs Agilent ChemStore C S comes with a set of built in tem plates to cover the most common needs for summary reporting These templates can be used as a starting point to bui customized reports Following is a list o reports e Analysis Results e Audit Trails rep e Compound Amor for individual res Instrument and Peak Details repo Kinetic Decay reports Sample Summary reports with numeric tables of the result information e Sequence summary report a complete report for GMP requirements including summa ry Statistics graphics of chro matograms and spectra and result charts with control limits for each compound type grouped by the sample type e System Suitability summary reports including statistics over replicate injections 14 e display of the selection criteria of the query e display of all custom calculations that have been used in the data section of the report e anoverall report header displayed on each page that allows to include graphic items such as a company logo e table information Example Only see your originals shipped with the p
206. ght wake up drug rs Test method batch Data type gt Test criterion According to ICH Units Run Number Additional header info Meas sys HPLC QS Number fantasy Header Re zl Device type Agilent 1100 Header line 2 v Device No for serial numbers see further header data Header line 3 Comment no comment Header line 4 v Ten d s Header line 5 GG Determination method Precision Pr Ta Precision Nominal value CY a D Precision It describes the extent of conformity between results obtained during repeated use of a set analytical Stability test I ICHQIA Study durati oO method under recurrent and comparable conditions a mena 10 Monitoring the precision will record random errors Initial value standard fo IO De Repeatibility conditions Repeated application ofthe Specification Value IV in o same analytical method to the same sample by the Minimum storage duration fo same operator with the same instruments inthe same laboratory within a short period oftime DIN 51848 Number of values 5 ISO 5725 Y Units Reproducibility conditions Repeated application ofthe E PSN same analytical method to the same samople by Se different operators with different instruments in TT Multiple injection Number per value fi different laboratories interlaboratory tests DIN 51848 ISO 5725 TT Multiple determination Number per value fi Calculated parameters are but not limited to Comment OK Cancel
207. gning see your originals outs The configur tons allow fc views Addit sent if additi modules hav certain instrument COmigurations that support instrument diagnos tics and verification procedures The ChemStation Companion view offers an easy to use interface specifically designed for the pro duction operator and routine labs Instrument operators can run sam ples from an easy to use precon figured table Each view consists of a set of standard user elements including menus and toolbars 12 shipped with the product or handed over by the Customer Engineer d analysis tasks including integra tion calibration reporting repro cessing annotation signal com parison and additional specialized tasks if the appropriate modules are installed Each of these sepa rate data analysis modes are sup ported with a task specific toolbar of its own The Report Layout view allows the user to graphically define the layout of a specific report style in a graphical object orientated fash lon It too uses a set of toolbars specific to this task Data Acquisition The status of the instrument is continually monitored and up dated on the display along with the elapsed run time of the analy sis both when the software is a visible window and when it is iconized The transactions that occur during the analysis includ ing any errors and the instrument conditions at the start and x of the analysis are recorde
208. gs 0 20 mm 0 008 Stator 20 ports 27 2 nl 45 ports 30 5 nl rotor seal 25 0 nl groove 41 MPa 408 bar 6000 psi 0 1 100 pl Agilent 1200 Series Qualification Workbook 2 Design Qualification DQ Phase Miscellaneous Specifications G1322A Vacuum Degasser Performance Specifications Table 43 Performance Specifications Agilent 1200 Series Vacuum Degasser Type Specification Maximum flow rate 10 ml min per channel Number of channels 4 Internal volume per channel Typically 12 ml per channel Materials in contact with solvent PTFE PEEK pH range 1 14 Analog output AUX For pressure monitoring range 0 3 V The G1322 Vacuum Degasser has been tested for evaporation of solvents into the atmosphere by an independent institute with approved methods The tests were performed with Methanol BIA Nr 7810 and Acetonitrile NIOSH Nr 1606 Evaporation of these solvents into the atmosphere when operating the degasser was below the limits of detection Physical Spesificarions Table 44 Physical Specifications Type Specification Comments Weight 7 kg 15 4 Ibs Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 44 Physical Specifications continued Dimensions width x depth x height Line Voltage Line Frequency Power consumption Ambient Operating Temperature Ambient Non operating Temperature Humidity Operating Altitude Non operating Altitude S
209. h user setable limits and feedback messages Electronic records of maintenance and errors Verification of wavelength accuracy with built in holmium oxide filter All materials recyclable ASTM Standard Practice for Variable Wavelength Photometric Detectors Used in Liquid Chromatography Reference conditions cell path length 10 mm response time 2 s flow 1 ml min LC grade Methanol slit width 4 nm Linearity measured with caffeine at 265 nm For environmental conditions refer to Environment in the manual Agilent 1200 Series Qualification Workbook Design Qualification DO Phase Physical Specifications Table 28 Physical Specifications Type Weight Dimensions width x depth x height Line voltage Line frequency Power consumption G1315C G1365C Ambient operating temperature Ambient non operating temperature Humidity Operating altitude Non operating altitude Safety standards IEC CSA UL EN Specification 11 5 kg 26 Ibs 345 x 435 x 140 mm 13 5 x 17 x 5 5 inches 100 240 VAC 10 50 or 60 Hz 5 160 VA 160 W 546 BTU 0 55 C 32 131 F 40 70 C 4 158 F lt 95 at 25 40 C 77 104 F Up to 2000 m 6500 ft Up to 4600 m 14950 ft Installation category II pollution degree 2 For indoor use only Comments Wide ranging capability Maximum Non condensing For storing the detector Agilent 1200 Series Qualification
210. hat can be used in conditions or expressions these include addition subtraction multiplication division absolute value count exponential logarithm natural logarithm mean value minimum maximum relative standard d square square root standard deviation sum variance le Multiple calculations can be defined within a single template based on any table or subtable All calculations are strictly column based operations and easily allow any kind of cross compound calculation for example for the determination of relative retention times as required in some regula tory methods for confirmation of a successful identification or for calculating relative responses The transpose wizard converts a table for doing cross run calculations such as the comparison of results to a reference run The group wiz ard provides for the ability of grouping a set of results by criteria Set Expression e x Table barbital Peak Time Table Alloharhital Peak Retention Info Walid expression r Data ltems H Available Data FA Tables Sd to Feness Example Only See your originals shipped with the product or handed over by the Customer Ines R ER i tai es et serve as a data s source for further calculations The IF condition wiz ard integrates with the expression builder and can filter result data based on virtually any condition The output can be reported according to the specific labo
211. he Agilent 1200 Series multi ple wavelength detector MWD SL G1365C support 80 Hz full spectral data acquisition The G1315C and G1365C support up to 80 Hz data acquisition of up to 8 signals additional instrument curves and offer data buffering on a built in Compact Flash Card to provide data never lost insur ance The cells and UV lamp uti lize RFID tags to capture and store lamp and cell information The improved Temperature Management System provides ambient rejection and stable cell temperature The ChemStation software can simultaneously acquire five chro matographic and reference signals each with an independent band width from the Agilent 1100 Series diode array detector G1315A or G1315B The system can simultaneously acquire up to a total of eight chro matographic and reference signals from the HP 1090 with an inde pendent bandwidth The detectors have a graphical test for signal intensity and wavelength tion All DADs may have the parameters changed during y a time based program zan program wavelength ectral acquisition mode s in the time table parameters that may be the DADs include signal ngths and reference ngths spectral acquisition mode signal sampling rate and autobalance The HP 1090 filter photometric detector FPD may be pro grammed with parameters to set the lamp current response time and the filter The filter may be changed during an analysis through events in the det
212. hem Station The Agilent ChemStation can dis play graphically the oven tempera ture inlet temperature inlet pres sure auxiliary channel pressure and column flow programs The Agilent ChemStation also can con trol through a timetable a maxi mum of eight valves or relays following sections each relating to a specific technique Bossa TH im de Ill a Sampling The Agilent 7673C and Agilent 7683 Series automatic samplers oHe lt r complete automation of introduction in single ngle rear or dual injector ations ector configurations 6890 Series 5890 II and rCs allow individual or nous injections Each ic sampler allows a 3 vial vial turret or 100 vial access f a sample tray is fitted 6890 and 5890 Series only The 6850 GC also supports the G2880A 22 27 positions tray The Agilent ChemStation allows ran dom sample access and priority sample injection The following autosampler para meters may be controlled e number of syringe pumps e number of syringe washes e the injection volume e the bottle number for each injection a viscosity delay on column injection setup syringe size depth of needle penetration e multiple injections per run in cooperation with PTV for large volume injection e For the Agilent 7683 Series plunger speed may be controlled from a maximum of 100 pl sec to a minimum of 5 pl sec when using a 10 pl syringe
213. hermostatted Column Compartment G1330A Autosampler Thermostat Agilent ChemStation Specifications Agilent ChemStation Plus Specifications Compliance Customer contributed documents Installation Qualification IQ Phase Side Preparation Specification Checklist Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification Agilent 1200 Series LC MSD G1956A B G2908BA G3218AA G3218BA Site Preparation Specification Agilent 1200 Series Qualification Workbook Contents Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G21 70BA G2171BA G2180BA Software Site Preparation Specification B 02 01 Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2073BA G2170BA G2171BA G2180BA G2090BA G2710BA G1601BA G2201BA B 02 01 Upgrade Site Preparation Checklist Installation Qualification Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist Agilent LC and CE ChemStation Software G21 0BA G2171BA G2175BA G2180BA G2185BA G211601BA G2172BA G2205BA Software Installation Checklist B 02 0x Familiarization Checklist Agilent 1200 Series Liquid Chromatograph Famliarization Checklist Agilent 1200 Series Liquid Chromatograph Scorp of Work Installation and Famliarization Declaration of Conformity and System Validation Declaration of Conformity According to ISO IEC Guide 22 and CEN CENELEC EN 45014 Declaration of Conformity to mannufacturing Specifications
214. http whadmin cos agilent com sear ch AdvPubForm asp by searching for GC IQ Attachment It is recommended to upgrade to the minimum firmware listed in the table using the GC Firmware Update Utility Copyright 2006 Agilent Technologies CHE Agilent Technologies Revision 6890N GC Firmware gt N 05 05 System LAN assembly 04 7B3 6890Plus Firmware gt A 03 08 6890A 6850 GC Firmware gt A 05 04 serial gt LAN assembly US10243001 04 7B3 6850 GC Firmware gt A 03 03 serial lt 9003200 Firmware gt A 05 04 Firmware gt E 01 02 Firmware gt A 03 02 Firmware gt A 06 00 1e GC Firmware Update Utility is ovided on the ChemStation 02 0x CD ROM under the Support directory Please check the Agilent Technologies website for the latest firmware http www chem agilent com script s cag_firmware asp Series II For CE systems only O If the firmware is not current ask the customer to upgrade to the minimum firmware Mainframe 2 3 DAD 1 2 WAD Product Support Page 2 of 3 Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2073BA G2170BA G2171BA G2171BA G2180BA G2090BA G2710BA G1601BA G2201BA B 02 01 Upgrade Site Prep Checklist ChemStation Solutions Check for installed Add On Solutions Before installing the Add On solution verify the correct revision of the Add On Solution Products for ChemStation B 02 01 using the using the link to the
215. i Device No for serial numbers see checkpoint header Header line 3 no comment 7 Header line 4 X row Header line 5 r Planning data r Sample data Number of samples i Sample Number of values Lab Capability Y Units p 1 6 Lower specification fo Upper Specification fo TT CalculateXb b fo B Same number of values per Multiple determination TT Multiple injection Number per value F Multiple determination Number per value e Lab capability is concerned with the relationship between the dispersion of values caused by the measuring process and the requirement such as specification Lab capability occupies a special position among validation concepts because it does not exclusively refer to the analytical method Comment WE F Cancel Figure 40 Planning dialog of checkpoint Lab Capability 53 The following results are always calculated for robustness ruggedness testing e standard statistics such as mean value RSD repeatbility and reproducibility along with confidence intervals for repeata bility and reproducibility and e variance homogenity according to Bartlett Linearity Linearity calculates a linear regression using the least square error for the model y a bx Linearity calculations can be carried out for multiple injections and multiple determinations Figure 41
216. ies ta and tb e t distribution e Method comparison e comparison of mean values Selectivity Specificity Selectivity means that an analytical method can distinguish the substance to be determined from other substances in the sample Example Only See your originals shipped with the product or handed over by the Customer Engineer Est Criterion Accoraing to ILA Units Run Number Meas sys HPLC QS Number fantasy Device type Agilent 1100 Device No for serial numbers see further header data Comment no comment m Planning data Number of values CE Y Units CT Nominal value resolution R i Chromatogram ee i crsSS m Multiple determination 1 1 Multiple injection Number per value Multiple determination Number per value Comment Figure 45 OK Cancel point selectivity The selectivity is determined from the resolution values calculated by the ChemStation Available calculation methods are tangent according to USP EP and ASTM sigma halfwidth and statistical Planning data e Number of values e Y units e Nominal value for the resolution R e Add chromatogram bitmap Vlultiple injections possible put settings available data including the ained resolution values are wn Miti x Station Plus Method Validation Pack Planning J ation method tangent USP EP ASTM 3d y F tangent USP E
217. iew also allows for a fast review of samples Batch Review is an additional mode of data analysis that pro vides automation by allowing a fast and easy first pass review of a batch of samples The batch con sists of all or a selection of runs from a sequence You can check the calibration accuracy and the individual integrations before approving the results All chro matogram specific modified inte gration parameters can be saved for data traceability Once data is accepted the entire batch can be reprocessed to generate reports with one keystroke 21 Good Laboratory Practice The 32 Bit ChemStation is devel oped to internationally recognized design and development standards and has a number of features specifically to help users operat ing in a regulated environment These features help users validate and specify methods verify that methods are fit for their intended use verify system performance and operation and ensure the traceability integrity and security of the data Development Process The Agilent Certificate of Validation shipped with ware package documer ware development and steps executed as part development cycle The ment process is registe ISO 9001 quality standa documented together w revalidation protocols i Validation CD ROM Method Specification and Use Global methods the complete instrument and data analysis specification is stored in one place Methods include individ ual c
218. ilable validations displays when selecting to open an existing validation The user Server Current DMS local ma Figure 50 Selection dropdown window for database connection selects the validation from the list with a simple click on the actual validation If users open older revisions of a validation the validation is opened in a locked status as read only Only saving it as the latest revision removes the Example Only See your originals shipped with the product or handed over by the Customer Engineer Pack data is stored under the Method Validation Pack root directory on the PC hard drive The Document Management System is located in a separate subfolder of the Method Validation Pack program directory The folder name is DMS This folder is protected with Windows file and Method Validation Pack User Ute Bober local login File Edit Validation Component Checkpoint Report View Security Utltes Window Help ai ca A Ei cry Ej El fa English report language Ci tor bel 2 ie Overview Figure 51 folder permissions It offers write only access to all authenticated users and only an administrative user has full access to the DMS directory Understanding and using file security is particularly important in standalone installations where aL is stored in the local data n a client server installation ault storage location should Oracle database that is stored parate server and that is not
219. ilent dual loop autosampler G2258A with illumination e Agilent thermostat option G1330A B e Agilent fraction collectors G1364A B C D e Agilent 1200 1100 Series barcode reader G2256A for the sample capacity extension G2257A Solvent Delivery Systems All the solvent delivery systems have a set of initial parameters including pressure limits initial flow and composition that are complemented by a time table for amming changes in flow position and pressure limits parameters can be viewed ically Users can define a in time for column equilibra lowing Agilent 1200 1100 it delivery systems are sup 1 atic pump G1310A e Binary pump G1312A e Binary pump SL G1312B e Quaternary pump G1354A G1311A e Preparative pump G1361A G1391A with gradient extension e Capillary pump G1376A pump only G1382A with degasser e Agilent 1200 1100 nanoflow pump G2226A pump only G2225A with degasser Column Compartments The Agilent 1200 Series ther mostatted column compartment SL G1316B can be set between 10 C and 100 C and provides post column cooling capability The Agilent 1100 Series ther mostatted column compartment can be set between 10 C below ambient and 80 C The tempera ture is programmable during the run through a timetable The HP 1090 column oven temperature can be set to a constant tempera ture 20 C above ambient to 100
220. in the DMS system The required space for an individual VDB file was discussed in the previous section Database parameter have been chosen for unattended operation tablespaces and datafiles extend automatically until their maximum file size has been reached Nevertheless you should keep in mind that frequent database maintenance and administration is ssary to ensure optimum brmance and correct and re operation backup tasks checks etc Your database inistrator may manually ind your database if necessary e is no known database size ation in Method Validation 7 Ve Large VDB data Database MB Database MB Database MB Initial size 30 Initial size 600 Initial size 1200 Maximal size 300 Maximal size 1200 Maximal size 2400 File growth 15 File growth 30 File growth 60 Comments Comments Comments Initial size 100 Initial size 1400 Initial size 2800 Maximal size 700 Maximal size 2800 Maximal size 5600 File growth 40 File growth 70 File growth 140 DMS data Database MB Database MB Database MB Initial size 20 Initial size 500 Initial size 2000 Maximal size 200 Maximal size 1000 Maximal size 4000 File growth 5 File growth 25 File growth 100 BLOBS BLOBS Initial size 180 Initial size 4500 Initial size 18000 Maximal size 1800 Maximal size 9000 Maximal size 36000 File growth 45 File growth 225 File growth 900 Table 13 Preconfigured database sizes for Method Validation Pack in a client server configuration using an Oracle relational d
221. in the selected user environment e Operational qualification OQ for testing the equipment in the selected user environment to ensure that it meets the previously defined functional and performance specifications e Performance qualification PQ for testing that the system consistently performs as intended for the selected application Agilent 1200 Series Qualification Workbook Overview 1 Qualifications Time Line Design Installation Operational cvalification qualification qualification deo IQ OQ PV PQ Calibrations Calibrations DO gt a Q gt lt Q _ PQ gt is Phase Phase Phase Equipment qualification _ gt User s responsibility Vendor assistance ies LE ME EE er Documentation Personal support SOPs Software Software Figure 1 Qualifications time line Agilent 1200 Series Qualification Workbook Overview Design Qualification DO Phase Definition and frequency Design qualification defines the functional and operational specifications of the equipment and details the conscious decisions in the selection of the supplier 3 The DQ phase is finished with the purchase of the equipment Who performs design qualification The user always should perform DQ The instrument s functional and performance specifications from the vendor can be used as a source for information The AGILENT TECHNOLOGIES 1200 Series concept All Agilent Techn
222. include element yn such as one might get tive detectors to nar row seaich results further Users can create edit import and export RTL libraries The RTL Pesticide Library prod uct number G2081AA includes the retention times for pesticides and suspected endocrine disrupters To use this library the RTL soft ware product G2080BA must be installed Peak identification is performed by comparing the reten tion time of the unknown peak with that of a standard included in the library table Agilent ChemStation for LC Systems Instrument Control and Data Acquisition with the Agilent ChemStation for LC Systems G2170BA and the Additional LC Instrument Module G2171BA The Agilent ChemStation for LC and additional LC instrument module controls and acquires data from the Agilent 1200 1100 Series modules and systems for LC the HP 1090 Series liquid chromatog raphy systems with either the fil ter photometric detector FPD or built in diode array detector DAD the stand alon diode array detector HP 1046A fluorescenc FLD the HP 1049A ical detector ECD al Agilent 35900E dual c faces All the samplin and detector options Agilent 1200 1100 Seri and systems for LC a HP 1090 Series liquid matographs can be controlled Sampling Systems The injection systems may be manual or automated with an autosampler or well plate auto sampler All automatic injectors may be programmed for diff
223. indoor use only Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Valves Specifications G1157A Agilent 1200 Series 2 position 10 port valve Performance Specifications Table 36 2 position 10 port valve Liquid contacts Stainless Steel and PEEK Port size Accepts 10 32 male threaded fittings Flow passage diameters Stator and stator face assembly 0 6 mm 0 024 rotor seal 0 6 mm 0 024 Volume in flow passage Stator includes stator face seal 2 1 pl hole rotor seal 0 7 ul groove Maximum pressure 41 MPa 408 bar 6000 psi Recommended flow range 0 2 100 ml min Physical Spesificarions for all Valves Table 37 Physical Spesificarions for Agilent 1200 Series Valves Type Specification Weight 1 9 Kg 4 2 Ibs Dimensions 92 x 84 x 200 mm height x width x depth 9 2 x 3 3 x 8 0 inches Power supply 24 Volts DC 1 7 amps Ambient operating temperature 4 to 55 C 39 to 131 F Humidity lt 95 non condensing Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 37 Physical Spesificarions for Agilent 1200 Series Valves continued Type Specification Safety Standards IEC CSA UL EN Installation category Il pollution degree 2 For indoor use only Revision Agilent 1200 Firmware A 05 04 and higher Control Module Firmware G1323B B 03 11 and higher Agilent ChemStation Software A 09 03 and higher Agilent 1200 Series Qualification Wo
224. ion to thooc mits for example 100 ids could have 20 levels calibration capability gt user to group calibrat into a named group and antitative results for both dual group members and Itself j i ra a Data Analysis Standard Reporting A standard set of user definable report styles for sample reporting are selectable from the report specification screen Every stan dard report type contains standard information groups and a series of optional information groups The standard groups include e A header with the originating data file and sample name e A footer with the instrument name operator name print time and page number in page x of y format e A sample information block that includes sample na number method an information operat instrument name al information text e A quantification res containing retentio the integration or q table depending on tion scheme choser can be formatted eli retention time or by signal Users may select from a series of optional information groups by specifying a particular style for the analytical report These groups include e A front page that can include user defined text Repetition of the sample infor mation block on every page e Instrument conditions The analytical column for LC and LC MSD systems The run logbook e The chromatogram with annota tion options that include selec tion from peak retention times compound names
225. ion of the validation in the ES Method Yalidation Pack User Ute Bober local login 18 x Eile Edit Validation Component Checkpoint Report View Security Utilities Window Help ID eW amp ry or os oe a i da E English report language gt Overview Arial lt 10 E AC Demonstration Substance A ME Stability short term Lower Upper None a EY Stability long term Standard Upward MI MD MI MD E ME Main Peak g gt Short report Modem TORE CEE F 9 10 11 12 13 114 115 16 17 18 LA gt 4 4 ofA TC 4 4 3Sign andrelease Sign and release n k r Electronic signature MICI Impurity A Time Cancel Linearity Precision repeatability Mm Precision reproducibility same site Precision reproducibility 2nd site Limit of detection quantification Recovery by spiking MIC Impurity B Linearity Precision repeatability Precision reproducibility same site ee SE Logon Precision reproducibility 2nd site Name ubober Recovery by spiking Carica a ME Total imps Precision repeatability Help _Sglect Change Pwd None Stability ChemStore C S Log On 4 x Password Precision reproducibility same site Precision reproducibility 2nd site Precision soln stability demo El RIC Unknown Impurity RAT 2 62 Precision sol stability Database MIMD Stability Line 42 Column 0 75
226. is installed automatically during the oo Example Only see your originals shipped with the product or handed over by the Customer Engineer Tecnnologies to maten analyte retention times between and among Agilent GC systems RTL is essentially based on void time matching through an empirically determined pressure retention time calibration curve RTL cali bration curves are specific to the analyte chosen pick one analyte in your standard the best choice is a peak well separated from other peaks and in the middle por tion of the chromatogram type of column used stationary phase type phase ratio and column dimensions carrier gas type and oven temperature program used in the method Once the calibration has been done for an initial original method the method and its associated RTL calibration can be transferred to another instrument with the same column type and carrier gas type RTL software in Agilent ChemStations assists with the process of deter mining and using RTL calibrations To lock a new system to the origi nal system carrier gas head pres sure is adjusted using the RTL cali bration curve The retention time of a target compound same one used to generate the RTL calibra tion can be locked onto the desired retention time value All lyte retention times will match those of the rare also provides the to search retention s Searching unknowns is narily on retention times uso
227. isions e Monitor the status of the Agilent ChemStation and instrument modules Details are shown in figure 15 21 Working with Agilent ChemAccess C S Data storage and organization Agilent ChemAccess C S enables the Agilent ChemStation results raw data methods and sequences to be securely stored on the Agilent ChemAccess Windows NT server The results can be transferred automatically at the end of each run or interac tively through the data analysis Agilent ChemAc view of the Agilent ChemStation If the same results are retrans ferred to the server Agilent ChemAccess C S employs data versioning to ensure that an entire record of the analysis is recorded Example Only See your originals Client hardware re Agilent ChemStatio ChemAccess C S The PC client should the requirements as Serre Agilent ChemStation Specifications Agilent publication number 5988 9925EN In addition to these requirements further 8 MB memory is required for network connectivity software and Agilent ChemAccess C S software Agilent ChemStation ChemAccess and ChemStore C S Configure the client using the Agilent ChemStore C S client hardware requirements specified in this document Client software requirements The ChemAccess C S client module can be added to the Agilent ChemStation The ChemAccess C S module is supported with the following ChemStation software packages 22 shipped with the product or handed over b
228. ith user settable limits and feedback messages Electronic records of maintenance and errors Housing All materials recyclable Physical Specifications Table 10 Physical Specifications Preparative Pump Type Weight Dimensions height x width x depth Line voltage Line frequency Power consumption Ambient operating temperature Ambient non operating temperature Humidity Operating Altitude Non operating altitude Safety standards IEC CSA UL Specification 15 0 kg 200 x 345 x 440 mm 8 x 13 5 x 18 inches 100 240 VAC 10 50 60 Hz 5 250 VA 4 40 C 41 104 F 40 70 C 4 158 F lt 95 at 25 40 C 77 104 F Up to 2000 m 6500 ft Up to 4600 m 14950 ft Installation Category II Pollution Degree 2 Comments Wide ranging capability Maximum Non condensing For storing the preparative pump for indoor use only Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase G1376A Capillary Pump Performance Specifications Table 11 Performance Specification Agilent 1200 Series Capillary Pump Type Hydraulic system Settable column flow range Recommended column flow range Column flow precision Optimum composition range Composition precision Delay volume Pressure range Compressibility compensation Recommended pH range Specification Two dual piston in series with proprieta
229. itved teri again in a custom sequence Alternatively partially executed and not finalized MVS sequences can be reloaded and re run after the already executed sequence lines have been manually deleted Finalizing a MVS sequence will also lock the validation and prevent it from further modification A validation can only be unlocked by an authorized user and requires an electronic signature MVS sequences are created with a specific command Create Study and MVS for ChemStation Plus in the Method Validation Pack software They are automatically built according to the validation configuration in the Method Validation Pack software no user interaction is required The MVS Example Only See your originals shipped with the product or handed over by the Customer Engineer robustness testing A convenient way to quickly fill in the method name is the sequence filldown wizard of the ChemStation Additional information is stored in protected custom fields This information displays the check point name the component name and a unique run ID for easy identification in the sample information text dialog These fields can only be configured and edited by the Method Validation Pack software sequence template is stored as a text document with the validation in the Document Management System DMS of the Method Validation Pack software Each injection translates into one line in the sequence table repetitive injections of the s
230. ity that the product as originally delivered Product Name 1200 Series Isocratic Pump 1200 Series Quaternary Pump Model Number G1310A G1311A Product Options This declaration covers all options of the above products complies with the essential requirements of the following applicable European Directives and carries the CE marking accordingly Low Voltage Directive 73 23 EEC amended by 93 68 EEC EMC Directive 89 336 EEC amended by 93 68 EEC and conforms with tha fallaine nraediint ctandarzia EMC Example Only mit See your originals oup 1 Class B shipped with the product Seli or handed ove r by the T Customer Engineer DV og dine 1 kV ne ground I 0 15 80 MHz PP ECONO FOTO ee cycle 20ms 100 Australia New Zealand AS NZS 2064 1 Canada ICES NMB 001 1998 The product was tested in a typical configuration with Agilent Technologies test systems 1200 Series module with LAN Communication Interface attached Safety IEC 61010 1 2001 EN 61010 1 2001 Canada CSA C22 2 No 1010 1 1992 A2 1997 USA UL3101 1 Supplementary Information This ISM device complies with Canadian ICES 001 Cet appareil ISM est conforme la norme NMB 001 du Canada This DoC applies to above listed products placed on the EU market after December 19 2005 4 bre Date Wolfgang Wilde Quality Manager For further information please contact your local Agilent Technologies sales office agent or distributor or Agilent Technologies Deutschland G
231. ized Reporting provide a means to test methods for robust ness The extended format reports for user selected criteria are reported as trend charts and may be used to determine the realistic operation limits These limits can then be incorporated in the method to ensure through the analysis of control samples that the method is operating within specifications 1 Operation emStation software verifi kit that is part of the stan ftware automatically for the correct operation lata evaluation parts of the e by comparing results ed when a test is executed pre recorded known val e verification test allows users to define their own data files and methods to be the basis of the test Data Traceability Integrity and Security e The run time logbook provides a transaction log of the complete system It also records any unusual events such as errors or parameter changes made during a run as well as the instrument conditions before and after each analysis A copy of the relevant logbook extract is saved with each data file e The actual instrument condi tions such as pressure flow and temperature that occurred during each analysis are also recorded if the configured instrument supports this capa bility This data can be subse quently displayed graphically with the chromatogram to show the actual instrument condi tions during that particular analysis These graphics may be included on ea
232. k Performance Qualification PQ Phase 5 Agilent 1100 1200 Series LC MSD Quad Major Preventive Maintenance Checklist Agilent 1200 Series Qualification Workbook Agilent 1100 1200 Series LC MSD Quad Major Preventive Maintenance Checklist Purpose of Procedure Preventive maintenance is a factory recommended procedure designed to reduce the likelihood of electro mechanical failures Failure to perform preventive maintenance may reduce the long term reliability of certain instruments and systems Two PM s per year are recommended the Major PM service will be performed annually with a Interim PM performed 6 months after the Major PM This checklist documents the Major PM service for the Agilent 1100 1200 Series LC MSD Quad instruments Customer Responsibilities Customers should ensure that all necessary operating supplies consumables and usage dependent items such as gases vial syringes calibrant solution and solv required for the successful preventi maintenance are available A customer representative should bi available while the preventive main procedure is being performed Important notice for customers The customer should complete the following before the Support Provic arrives on site LA O Perform a dual polarity Autotune and retain the printed tune report Parts required 6040 0834 Rough pump fluid 1L 1535 4970 Mist filter element BHT 4 Nitrogen gas filter 0100 2051 Inlet filter Sum fri
233. k in a clieni version The product nu listed in the table next ti along with the required 38 Description ChemStation Plus Security Pack Adds the secure ChemStore C S relational database add on software module to the ChemStation Plus SW for A D GC CE LC and CE LC MSD Supports 21 CFR Part 11 Includes user documentation licenses and media License to use G2183AA on another PC Includes license and user information only Supports 21 CFR Part 11 Must be on same order as G2183AA or requires a valid license for G2183AA ChemStation Plus client upgrade software Upgrades a single ChemStation Plus client to the latest software revision Requires valid software licenses and ChemStation upgrade software G1656A Example Only see your originals shipped with the product i or handed over by the Customer Engineer tware tabase ChemStation Plus Security Pack Adds the secure ChemStore relational database add on software module to the ChemStation Plus client server SW for A D GC CE LC and CE LC MSD Supports 21 CFR Part 11 ChemStation Plus ChemStore client license Includes one online ChemStation Plus license for online data acquisition and one ChemStore C S offline data review license Includes license and user information only Requires but does not include ChemStation Plus software media License to use G2183AA on another PC Can be used as additonal copy for standalone installations or as additional Securi
234. l ChemStore C S databa on a per study basis F the transfer of a set of also include chromato spectra and the raw d and sequence file used wo produce those results Custom fields allow additional information or result fields to be linked to each set of results run They are used to store additional information that is not accessible from the Agilent ChemStation method or results that is informa tion which may reflect other mea surements for example LIMS ID sample pH patient weight dosage and so on or may be used to organize the data for example the identification code of the test patient from whom a serum sam ple was obtained These custom fields may be configured as required or optional For the former a value must be specified before results can be transferred to the database or a sequence can be executed Custom fields can also be used in later queries for reports custom calculations or charts Study and custom field configuration A custom field and its type are defined globally per database as shown in figure 3 The available field types are e True False selection e Configurable selection list e Integer value 1 Peal value Example Only See your originals shipped with the product or handed over by the Customer renames eee Se uyu er eee fields can be flagged as required Create Field byiCustomeield Data type True f False Mame
235. l and plastic cap in the outlet ball valve 2x Q Change the frit located in the filter in front of the EMPV O Perform the EMPV test procedure Result Pass Fail O Perform built in pressure test Result D Pass F ail e If the system is used in mi mode perform the Micro pressure test Pressure value e If the system is used in nor mode perform the Normal mode Slope of pressure test Pass Fail Pressure ramp Pressure Pass Fail value Final Pressure drop Pass Fail G1361A Preparative Pump For a binary setup perform these steps for both pumps Q 1 Record serial number O 2 Record serial number Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies Q Remove and disassemble pump head Q Remove and clean plungers Clean support rings Remove old seals clean piston chambers and replace seals Q Reassemble pump head and install on metering drive O Replace the filter cup in the Multi Assy O Pump 200 ml of IPA through the pump Replace the SST filter assembly Replace the seal wash pump cartridge and tubings m Perform the FMPV cleanino DU Example Only see your originals shipped with the product or handed over by the Customer Engineer 1 Result Pass Fail 2 Result Pass Fail SAMPLERS G1329A Autosampler G2260A Prep Autosampler Q 1 Record model number Q 1 Record serial number O 2 Record model number Q 2 Record serial numb
236. l substance typically 24 48 hours In both cases the study duration the initial value initial amount or response of a freshly prepared standard and the specification limit in percent acceptance 52 interval are entered For long term stability a minimum storage duration as acceptance period is additionally specified Precision can be performed with multiple injections as well as multiple determinations Figure 38 shows the planning dialog for checkpoint precision Planning data e Determination method e Precision IN 4 e a Example Only See your originals shipped with the product or handed over by the Customer Engineer UOIILIUETICE IFILET Val e Error of result e Trend test according to Neumann e Outlier test according to Dixon Grubbs e Normality check Sharpiro Wilk Test e Method standard deviation e Mean value e Correlation coefficient Robustness Ruggedness Robustness is defined as the inde nce of an analytical result gt hanges in other parameters could influence the result dness of an analytical id is given if the deviation oratory mean values is not cantly different from the ion of all measured values dness should show the Hity of an analysis with t to the influence of transferring a method to another Headers m ChemStation Plus Method Validation Pack Planning Product Late ni
237. lates MTP 10 x 2 ml vials 108 x 2 mL vials in 2 x 54 vial plate plus 10 additional 2 mL vials 30 x 6 mL vials in 2 x 15 vial plate plus 10 additional 2 mL vials 54 Eppendorf tubes 0 5 1 5 2 0mL in 2 x 27 Eppendorf tube plate Typically lt 30 s using following standard conditions Default draw speed 4 ul min Default eject speed 10 ul min Injection volume 0 1 ul Typically lt 0 05 using the following conditions Column 150 x 0 5 mm Hypersil ODS 3 um Mobile phase Water Acetonitrile 85 15 Column Flow rate 13 ul min Injection volume 1 pl caffeine 25ng caffeine 1 ul water to test carryover Outside wash of needle before injection 20 sec with water using flush port 2 Design Qualification DO Phase Detectors Specifications G1314B Variable Wavelenght Detector and G1314C Variable Wavelenght Detector SL Performance Specifications Table 23 Performance Specifications Agilent 1200 Series Variable Wavelength Detector Type Detection type Light source Wavelength range Short term noise ASTM Drift Linearity Wavelength accuracy Band width Specification Comments Double beam photometer Deuterium lamp 190 600 nm 0 75 x 10 AU at 254 nm See NOTE on page 31 3 x 107 AU hr at 254 nm See NOTE on page 31 gt 2 AU 5 upper limit See NOTE on page 31 1nm Self calibration with deuterium lines verification with holmium oxide filter 6 5 nm typical Agilent 1200 Series Qualification
238. lease ask your local Agilent Technologies representative for details e LAN communication with the Agilent 1100 Series requires a minimum firmware revision of A 06 02 The G1315C DAD SL and G1356C MWD SL detectors require a minimum firmware Customer Engineer LAN interface cards are used to connect analytical instruments to the LAN Jet Direct or G1369A LAN cards are required The mini mum firmware required for LC systems used with the G1369A LAN card is Rev A 01 05 or higher For non LC systems 85900E ADC 6890 GC and 6850 GC a minimum Firmware Revision of C 03 00 is required Additional details are available in the Agilent G1369A LAN Interface manual Communication Protocols Instruments are controlled over LAN using industry standard TCP IP Transmission Control Protocol Internet Protocol It is necessary to verify correct com munication between the PC and analytical instruments connected over the LAN The Microsoft TCP IP protocol needs to be installed and configured as a net work protocol on the PC The boot strap protocol is used to gt ure the JetDirect or G1369A ard The Boot strap proto uires a BootP service to the readme Agilent no supports the Bootp 2 The Agilent BootP 2 Program uses the LAN unication parameters speci the Configuration Editor to sh communication The t BootP Service Program can be used for central adminis tration and distribution of IP addresses and settings Fixed IP A
239. lent instruments RQ provides documented evidence that proper techniques and procedures are utilized This is accomplished through ISO trained technicians who use traceable documented tools and equipment to ensure that the work they do meets all facets of compliance Performance Qualification PQ maximizes uptime and productivity PQ is a method for a lab to perform ongo ing self validation and is an excellent way to head off potential problems before they occur Small problems can be identified and remedied before they become costly In addition consistent PQ allows formal compliance procedures to move much more rapidly because there are traceable paths of documentation demonstrating prior inspections and service To support a lab s PQ program Agilent offers preventive maintenance services to ensure maximum instrument uptime and extended life Agilent s service professionals can perform a documented list of maintenance procedures on your instrument prior to performing a qualifica tion procedure Preventive maintenance can be scheduled to coincide with PQ to minimize instrument downtime A lab s validation plan or change control program should define when it needs to qualify instruments and software to ensure compliance with quality and regulatory requirements Compliance solutions for all Agilent software Accurate data management is critical to a lab s total compliance agenda Agilent Otters a range of produ
240. lent 1200 Series 12 position 13 port selection valve Table 40 12 position 13 port selection valve Liquid contacts Port size Flow passage diameters Volume in flow passage Maximum pressure Recommended flow range Stainless steel and PEEK Accepts 10 32 male threaded fittings 1 0 mm 0 040 Stator includes stator face seal 6 4 ul hole rotor seal 4 0 ul groove 21 MPa 207 bar 3000 psi 0 2 100 ml min at high pressures after the pump 0 2 10 ml min at low pressures in front of the pump Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase G1162A Agilent 1200 Series 2 position 6 port micro valve Table 41 2 position 6 port micro valve Liquid contacts Port size Flow passage diameters Volume in flow passages Maximum pressure Recommended flow range DuraLife processed stainless steel stator and vespel rotor seal Accepts M4 male threaded fittings 0 20 mm 0 008 70 nl port to port 41 MPa 408 bar 6000 psi 0 1 100 ul Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1163A Agilent 1200 Series 2 position 10 port micro valve continued Table 42 2 position 10 port micro valve Liquid contacts Port size Flow passage diameters Volume in flow passages Maximum pressure Recommended flow range DuraLife processed stainless steel stator and vespel rotor seal Accepts M4 male threaded fittin
241. lent 1200 Series sample capacity extension for further expansion of the sample capacity Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 20 Performance specifications Agilent 1200 Series High Performance Autosampler and Agilent 1200 Series High Performance Autosampler SL continued Injection cycle time Typically lt 30 s using following standard conditions Default draw speed 200 ul min Default eject speed 200 ul min Injection volume 5 pl Carry over Typically lt 0 01 using the following conditions Column 125 x 4 mm Hypersil ODS 5 um Mobile phase Water Acetonitrile 80 20 Flow rate 1 ml min Injection volume 1 pl caffeine 1 mg ml 5 ul water to test carryover Outside wash of needle before injection 20 sec with water using flush port Physical Specifications Table 21 Physical Specifications sampler G136 B C G1377A Type Specification Comments Weight 15 5 kg 34 2 Ibs Dimensions 200 x 345 x 440 mm height x width x depth 8 x 13 5 x 17 inches Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption apparent 300 VA Maximum power Power consumption active 200 W Maximum power Ambient operating temperature 4 to 55 C 41 to 131 F Ambient non operating 40 to 70 C 4 to 158 F temperature Humidity lt 95 at 25 to 40 C Non condensing 77 to 104 F Agilent 1200 Series Qualific
242. lent ChemStation for cee GC LC LC MSD CE and A D Systems 00 Rev B 02 01 Specifications Example Only What s New in Rev See your originals shipped with the product or handed over by the Revision B 02 01 is the n in active development ol C u sto Mer E yg Neer Agilent ChemStation Its User Interface addresses cus e New and improved tomer s growing needs for faster ChemStation User Interface acquisition and review of data A design modern tree view along with a e New tree and table based navi new navigation table allows easy gation providing fast and flexi finding sorting and review of ble Data Handling within vari multiple sample data It adopts ous ChemStation views new Microsoft technologies while e Improved data review and maintaining well known reprocessing capabilities using ChemStation concepts to avoiding the Data Analysis Navigation need of re training Table e Flexible storage locations for Note Rev B 02 01 Agilent data methods and sequences ChemStation software release e New packaging concept for does not relate to UV VIS or sequence data guaranties con GC MSD instrumentation These sistency of all methods and instruments are controlled and results within a sequence supported by separate Agilent e Additional signal options give ChemStation software products possibility to assign method HE Agilent Technologies May 2006 lc signal options to ve data review _dility to save manual int
243. les and sample audit trail The sample e adetailed change documentation audit trail creates for each result of manual integration events change one new line in the audit e all approval events including trail table It displays both the the name of the approver date interactive manual changes and amp timestamp approval com the system generated entries each ment and the level of approval in a separate line Examples for i Opened Logbook File BATCH LOG BATCH S completed 17 41 58 06 08 00 Sequence ChenStore Data spooled to hpcs 17 41 57 06 08 00 Method Method conpleted 17 41 57 06 08 00 CP Macro Analyzing rawdata 007 0301 D 17 41 43 06 08 00 Method Method started line 5 vial 7 inj 1 17 41 43 06 08 00 ChenStore Data spooled to hpcs 17 41 41 06 08 00 Method Method completed 17 41 41 06 08 00 CP Macro Analyzing rawdata 006 0201 D 17 41 27 06 08 00 Method Method started line 4 vial 6 inj 1 17 41 27 06 08 00 ChenStore Data spooled to hpcs 17 41 26 06 08 00 Method Method conpleted 17 41 25 06 08 00 CP Macro Analyzing rawdata 005 0103 D 17 41 13 06 08 00 Method Method started line 3 vial 5 inj 1 17 41 12 06 08 00 ChenStore Data spooled to hpcs 17 41 11 06 08 00 Method Method completed 17 41 11 06 08 00 CP Macro Method BATCH M updated after recalibration 17 41 11 06 08 00 CP Macro Recalibration done 17 40 55 06 08 00 CP Macro Analyzing rawdata 005 0102 D 17 40 52 06 08 00 Method Method started
244. lification Workbook 000 eoee 5 Performance Qualification PQ Phase Preventive Maintenance Checklist Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist Agilent 1200 Series Liquid Chromatograph Scorp of Work Preventive Maintenance Agilent 1100 1200 Series LC MSD Quad Major Preventive Maintenance Checklist Agilent 1100 1200 Series LC MSD Quad Major Interim Preventive Maintenance Checklist System performance and noise Customer contributed material For the items marked with a example pages are added It is the responsibility of the user to replace these with the originals The user should feel free to add further documents e g not supplied by Agilent Technologies whenever he thinks this is appropriate Fip Agilent Technologies 5 Performance Qualification PQ Phase Preventive Maintenance Checklist Agilent 1200 Series Qualification Workbook Performance Qualification PQ Phase 5 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist Agilent 1200 Series Qualification Workbook Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist Purpose of Procedure Preventive Maintenance is an Agilent Technologies recommended procedure designed to reduce the likelihood of electro mechanical failures Failure to perform preventive maintenance may reduce the long term reliability of certain instruments and systems Customer Responsibilities
245. line Planning data Selects the calculation method from a pool of possible calcula tions available for this check point m Headers Product Number of samples and y unit Defines the number of independent samples used for calculations Note By default minimum number must be six and the system will show missing values either as Zero or as MV in case the configuration allows 0 as valid data input Each sample translates into a separate sequence line and thus sample vial Multiple injections or determinations Multiple injections means renetitive inieetiane from the Example Only See your originals shipped with the product or handed over by the Customer Engineer late night wake up drug batch Test criterion rion According to ICH Dimension Run number Meas sys HPLC fantasy Agielnt 1100 for serial numbers see checkpoint header no comment _ Device type Device No m Planning data Determination method Comparison with nominal value Nominal value p 2 Method comparison with joined sample Method comparison Nominal value CV 0 Standard addition Number of values with matrix Oo Extended spiking method Addition z fol C Recovery Accuracy by recovery Nominal value CV Number of samples 6 Y Units Multiple determination TT Multiple injection Number per value M Multiple determination Number per value
246. llation Agilent 1200 Series Qualification Workbook 1 Overview Contribution of the Qualification Workbook The chapter Installation Qualification IQ Phase contains documents showing current installation qualification The chapter must be updated by the user if a change happens to the system e g when a new software revision is installed Operational Qualification 00 Phase Definition and frequency Operational qualification is the process of demonstrating that an instrument will function according to the operational specification in the selected environment 3 This process is called Operational Qualification 0Q in the Pharmaceutical FDA environment and Performance Verification PV in the ISO EN Accreditation environment The tests have to be performed by the user on a regular basis In general users should select time intervals between the tests so the probability is high that all parameters still are within the operational specifications Typically the respective tests should be performed e After installation e After a change to the system e After a major repair e At defined time intervals For AGILENT TECHNOLOGIESLC equipment the interval is typically one year Who performs operational qualification performance verification OQ can be performed either by vendors or users Business or economics needs rather than technical concerns determine this choice The decision mainly depends on the resources available a
247. lly through users with administrative rights in the ChemStore C S database and is automatically applied on all connected ChemStation Plus clients The session lock allows to lock each instrument session individually and independently so users sharing computers with two or more instruments connected to one computer can operate with a clear user distinction and unique user identification The name of the current user and the instrument session are always shown in the title bar The instrument sessions can be locked either e privately allowing only the user who locked the session or an administrator to unlock it or e non privately allowing all users with a valid user ID in the data shipped with the product or handed over by the Customer Engineer Administer Users User Create new user User dd Change display name Deactivate User D Print user profile Permigsione granted Clear password IT User permissions Individual permissions Administer custom fields gt Administer user settings Administer users Approval configuration Assign Studies to Users delp HPH Figure 16 User Management in ChemStation Plus Security Pack ur LOT ILE amp Instrument 1 offline 1 Method amp Run Control Instrument Operator File RunControl Instrument Method Sequence ChemStore View Abort Help Method and Run Control J BATCHM fe 1 Method and Run
248. ly reflected in all the others This mode allows graphical selection and modifica tions of the calibration data Quantification is based on Normalized External standard External standard Internal standard and Internal standard calculations calculated on either peak area or height Calibrations may be multilevel and include multiple internal standard defini tions Calibration histories are automatically saved and can be used to weight the recalibration calculations e tangent skim processing including solvent peak defini tion commands e the ability to define individual front tail tangent skim calcula tions event tables for all chro matographic signals e the ability to use baseline cor rection parameters non signal related e integrator control commands defining retention time ranges for the integrator operation pulder allocation the use of second 7e or degree of curva culations and d sampling of non ant data points for bet yrmance with DAD LC s that are reconstructed D spectra The following calibration point weighting options are available Equal All calibration points have equal weight in the curve Linear Amnt A calibration point with the amount x has the weighting 1 x normalized to the smallest amount so that the largest weight factor is 1 Normalization is done by multiply ing the weight with the smallest amount For example the weight of a calibration point with
249. m G2070AA to G2070BA ChemStation instruments and modules are appropriate for ChemStation B 02 01 User defined column entries in the GC Column catalog are not transferred automatically during an upgrade from G2070AA to G2070BA ChemStation If Firmware is not current ask customer to upgrade to minimum Firmware A 06 02 B 01 02 required with Rev B 02 01 ChemS Please use the record outli 1100 1200 IQ Attachmer This document is availabli EPI Warehouse http whadmin cos agilen ch AdvPubForm asp by se for 1100 1200 PM Check 1100 1200 IQ Attachment AND the 1100 1200 PM will be retrieved The 110 Attachment Form is to be 5m once The FW upgrade process is described in the manual coming with the FW upgrade tool placed on the ChemStation CD ROM m For LC MS systems only E Update the LC MSD firmware by running the executable c Chem32 MS FIRMWARE msupdate exe while connected to the LC MSD Before upgrading the LC MSD ChemStation to revision B 02 01 perform a dual polarity Autotune to verify instrument tune performance and to generate a record of current tune parameters Issued Feb 2006 Rev 1 0 The GC Column Database Utility can be used after the upgrade to transfer the user defined GC Columns Example Only see your originals shipped with the product or handed over by the Customer Engineer SIA o 2 eS Se Se eS es ee ee ee aV ve y aa U a w from the EPI Warehouse
250. mAccess Rev 4 02 0 a ER cues See your originals Tr na shipped with the product or handed over by the Customer Engineer DOD Diskspace D 18 01 GB Instrument Sef System Status Not Ready Method DEF_GC M 2 Instrument 2 E System Status Run in Progress M eth D d D E FLC hd WaADC21 45 Diskspace 4 Li Press F1 for help Figure 15 Agilent ChemAccess C S remote status and control user interface matically and securely stored onto the Agilent ChemAccess C S server This functionality is largely superceded when com bining or adding Agilent ChemStore C S to a Agilent ChemAccess C S system An Agilent ChemAccess C S data system contains Agilent ChemStation clients the Agilent ChemAccess C S software and a oft Windows NT server ChemAccess C S is com with both the multi tech gilent ChemStation and alysis versions enabling and cost effective remote nonitoring control and from locations which are 1 away from the laborato trumentation Remote status and monitoring and control From any Agilent ChemAccess C S client an authorized user can remotely perform the following tasks on a remote instrument e Start and stop the method or sequence currently running e Assign a method or sequence e Real time plot of the instrument signals e Execute a remote Agilent ChemStation command e Monitor the status of the remote PC s resources disk space memory and software rev
251. may require additional connecting capillaries Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 4 of 8 Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification edite Agilent Technologies Figure 1 Recommended 1 Stack Configuration Example Only See your originals shipped with the product or handed over by the umn Gee Customer Engineer Solvent cabine Pump INS terne Pilot Autosampler or Micro Autosampler or Preparative Autosampler Column compartmeht Detector Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 5 of 8 Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification Ro Agilent Technologies Figure 2 Recommended 2 Stack Configuration with Thermostat Example Only See your originals shipped with the product ama or handed over by the compartment Customer Engineer Detector Solvent cabinet Autosampler Vacuum degasser Thermost Pump Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 6 of 8 Agilent 1200 Series Liquid Chromatograph dl Agilent Technologies Hardware Site Preparation Specification Figure 3 Recommended 2 Stack Configuration with Fraction Collector Analytical Scale System I Solvent bottles II Degasser
252. mbH Herrenberger StraRe 130 D 71034 Boblingen Germany ment No G1311 Docu 1311 90510 AM EMA NU AU UN NT AU AU Revision 3 Installation Qualification 10 Phase Declaration of Conformity to mannufacturing Specifications Agilent 1200 Series Qualification Workbook pp Agilent Technologies Declaration of Conformity to manufacturing specifications We herewith inform you that the product G1311A with serial number DE60555268 has successfully passed all our production quality tests During final instrument performance verification the following functional characteristics were Example Only see your originals shipped with the product or handed over by the Customer Engineer Operational Test V1 February 20 2006 4 Signature Test Technician Sven Buggermann casa TIM pesesss268 A TI Installation Qualification I0 Phase 3 ChemStation Declaration of System Validation Agilent 1200 Series Qualification Workbook HE Agilent Technologies Declaration of System Validation We herewith inform you that the software product system Product Number ChemStation for GC G2070BA G2071BA G2075BA B 02 0x G2090BA where x ranges from 0 to 9 ChemStation for LC G2170BA 2171BA G2175BA B 02 0x ages from 0 to 9 ChemStation Example Only ChemStation see your originals shipped with the product ges rome or handed over by the ages from 0 to 9 Customer Engineer liges from 0 to
253. med the Major PM Ign Vacuum i O heck lly that have t i This checklist documents the Interim PM mae an d Ha ae Q Affix the PM Sticker to the service for the Agilent 1100 1200 Series p 2 l 1100 1200 LC MSD Quad system or LC MSD Quad instruments in the customer logbook as specified Q Vent the instrument by the Customer Customer Responsibilities Note The purpose of generating tune reports Customers should ensure that all rx operating supplies consumables a ECO i s functional in positive and dependent items such as gases vi Exa m p i e O n ly des Autotune should NOT be syringes calibrant solution and so required for the successful preven 5 ee Vo UTO FI y Na S maintenance are available Le u otune should be run after the A customer representative should shipped with the product has been allowed to thermally available while the preventive ma ate for at least 11 hours procedure is being performed OF ha n ded over by th e ng a system vent During this is not unusual for the Important notice for customers C U sto mer F I g Neel ent to exhibit mass assignment The customer should complete the i Door peak shapes and or poor following before the Support Prov arrives on site tive maintenance is to verify that t this time O Verify system line voltage meets O Perform a dual polarity Autotune and instrument specifications retain the printed tune report Q Service Order SO Number O Meas
254. method vali guidance documents In oi method validation is the of evaluating and docum performance of an analy method to ensure that th is suitable for its intende ensuring compliance wit or method requirements outcome should provide confidence in the result with a particular method The analytical purpose of the method validation experiments is to provide a master method with a master chromatogram for all con secutive separations of this partic ular sample Method validation testing must compare results of multiple runs it is inter chromato graphic in order to answer the question is this method suitable for the separation task The com parison must give a qualitative and quantitative answer to this question based on the analytical results A comparison typically involves a human judgement so how can a comparison provide a user inde pendent and quantitative result This is the most difficult task in the method validation process because proper execution requires 1 The definition of general good quality criteria for a method to address the qualitative require ments and 2 The definition of specific requirements for the individual analytical problem to address the quantitative question Eventually it requires an answer to the question does this method provide good results based on independent requirements For step 1 ICH and FDA used the definition nf seneral cand aialityw Exam
255. more than one checkpoint Mark the checkbox if you wantto use the data of one checkpoint in others M Share Data between checkpoints Replace IDs This validation has already been exported and there is data for it in Chemstore available Overwriting the existing IDs makes another import of these data impossible PIONEER CREER Arersessnrone senese za ninnenasnanenetanzansanitoonsenesnneti Choose Operator Please choose operator name for this MVS job Select for an all user job Ute Bober Done Generate MVS Figure 32 Options for generation of Method Validation sequence ChemStation Plus system Method method validation sequences Validation Pack transfers the theo MVS The user has three options retical validation planning into a during sequence generation list of analytical runs by creating As shown in figure 32 the validation one or multiple ChemStation Al can be transferred into BEE EJ Method Validation Pack User Cnickel Chr nickel local login Elle Edit Yelidston Component Checkpoint Hepat Vi ew Security Ufities Window Help e asingle sequence for the D bed SQ i Ds se e oh E El E German report language IE 2 N HOE PEINE x complete validation e one sequence per component e or a set of user defined custom sequences The custom sequence option allows to define as many sequences as required in any combination of the i
256. moving target and a significant source of stress for those Involved in the process Let Agilent remove the stress of compliance and take the heat off you and your lab once and for all Then your lab can focus on analytical results not extinguishing the flames of non compliance Agilent s line of proven qualification products and services takes the heat off you and your lab Agilent provides the most complete line of compliance products and services available allowing labs to select service for Agilent instruments Agilent software and even products trom other manufacturers Agilent offers a complete compliance program that enables lab managers to make one call for any or all of their needs no matter what the brand no matter what the service Agilent offers customer focused products and services for all stages of an instrument s life cycle From installation and upgrade to operation and repair Agilent provides the resources and tools necessary to ensure compliance is not a burning Issue When compliance heats up Agilent keeps you cool Compliance products and services for Agilent instruments An investment in Agilent instruments ensures maximum productivity To maintain the highest level of operation a suite of products and services is available These products and services take into account the various phases of an instrument s life cycle and allow the lab to customize a compliance program based on specific needs F
257. mp Safety standards IEC CSA UL Installation Category II Pollution Degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase G1311A Quaternary Pump Performance Specifications Table 3 Performance Specification Agilent 1200 Quaternary Pump Type Hydraulic system Setable flow range Flow range Flow precision Flow accuracy Pressure Pressure pulsation Compressibility compensation Recommended pH range Gradient formation Composition Range Composition Precision Control and data evaluation Analog output Communications Specification Dual plunger in series pump with proprietary servo controlled variable stroke drive floating plungers and active inlet valve 0 001 10 ml min in 0 001 ml min increments 0 2 10 0 ml min lt 0 07 RSD or lt 0 02 min SD whatever is greater based on retention time at constant room temperature 1 or 10pul min whatever is greater Operating range 0 40 MPa 0 400 bar 0 5880 psi up to 5 ml min Operating range 0 20 MPa 0 200 bar 0 2950 psi up to 10 ml min lt 2 amplitude typically lt 1 at 1 ml min isopropanol at all pressures gt 1 MPa 10bar User selectable based on mobile phase compressibility 1 0 12 5 solvents with pH lt 2 3 should not contain acids which attack stainless steel Low pressure quaternary mixing gradient capability using proprietary high speed proportioning v
258. mperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the quaternary pump Safety standards IEC CSA UL Installation Category II Pollution Degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase G1312A Binary Pump Performance Specifications Table 5 Performance Specification Agilent 1200 Binary Pump Type Hydraulic system Setable flow range Flow range Flow precision Flow accuracy Pressure Pressure pulsation Compressibility compensation Recommended pH range Gradient formation Composition range Composition precision Composition accuracy Control and data evaluation Analog output Communications Specification Two dual piston in series pumps with proprietary servo controlled variable stroke drive floating piston design and active inlet valve Setpoints 0 001 5 ml min in 0 001 ml min increments 0 1 5 0 ml min lt 0 07 RSD or lt 0 02 min SD whatever is greater based on retention time at constant room temperature 1 or 10ul min whatever is greater Operating range 0 400 bar 0 5880 psi up to 5 ml min lt 2 amplitude typically lt 1 at 1 ml min isopropanol at all pressures gt 1 MPa User selectable based on mobile phase compressibility 1 0 12 5 solvents with pH lt 2 3 should not contain acids which att
259. mples and user defined report layouts System Suitability Reports System suitability reports enable users to report system perfor mance parameters for individual analyses There are three tions or styles of these ri The Standard Performar prints parameters for un methods that include retention time capacity factor k peak area peak height symmetry true peak width at half n ignt efficiency in plates resolution and selectivity For calibrated methods the com pound name and amount replace the peak area height and selectivi ty columns The report header includes the standard header and footer sam ple information block the analyti cal column parameters and optionally a plot of the chro matogram The Performance and Noise style adds an evaluation of the signal noise in up to seven user defined evaluation ranges to the data from the performance report style The noise parameters are reported as a signal to noise ratio for each peak or calibrated compound and a noise table for each signal Each noise table includes noise calcu lated by the six times standard deviation peak to peak and ASTM methods as well as the wander and drift The Extended Performance style adds plots of each individual peak showing graphically the peak start and stop times half width and Example Only see your originals shipped with the product or handed over by the Customer Engineer e Statistical Moments
260. n DO Phase Table 1 Performance Specification Agilent 1200 Isocratic Pump continued Safety and maintenance Extensive diagnostics error detection and display through control module and Agilent ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas GLP features Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase with user settable limits and feedback messages Electronic records of maintenance and errors Housing All materials recyclable For use with flow rates below 500 pl min a vacuum degasser is required Physical Specifications Table 2 Physical Specifications Type Specification Comments Weight 11 kg 25 Ibs Dimensions 140 x 345 x 435 mm height x weight x depth 5 5 x 13 5 x 17 inches Line voltage 100 120 or 220 240 VAC Wide ranging 10 capability Line frequency 50 or 60 Hz 5 Power consumption 220 VA Maximum Ambient operating temperature 4 55 C 41 131 F Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 2 Physical Specifications continued Non operating altitude Up to 4600 m 14950 ft For storing the isocratic pu
261. n Depth 13 0cm Width 18 0 cm 5 1 in 7 1 in J Agilent G1978A Multimode Source Weight 2 29 kg Height 23 cm 5 05 Ib 9 2 in Depth 13 0cm Width 18 0cm a 5 1 in 7 1 in The footprint dimensions represent the minimum dimensions of the supporting surface This surface must also be relatively vibration free and capable of supporting at least 65 kg 143 Ibs Maximum cabinet dimensions are for an Agilent G1956A B with an Agilent G1947A APCI G1971A APPI or G1978A Multimode source installed At least 30 cm 1 ft to the left of the cabinet and at least 55 cm 1 8 ft above the cabinet must be added to these dimensions to provide adequate instrument access Copyright 2005 Agilent Technologies LC MS Technical Marketing Page 1 of 3 Agilent 1200 Series LCIMSD G1956A B G2908AA G2908BA G3218AA G3218BA pp Agilent Technologies Site Preparation Specification Environmental Conditions Temperature 15 to 35 C 59 to 95 F Tick Boxes at constant temperature variations lt 3 C hr Humidity lt 95 relative non condensing CI Power Americas amp Japan 200 to 220 VAC 1100 VA max Europe amp Asia Pac 220 to 264 VAC 1500 VA max G1971A APPI Source 110 240 VAC 15 VA max O G1978A MM Source 110 240 VAC 15 VA max N Generator 90 110 VAC 15 VA max 108 132 VAC 15 VA max 207 253 VAC 15 VA max All power 50 60 Hz 5 Single outlet for LC MSD See LC MSD Site Preparation Manual G1956 900
262. n revision 1 or later at ChemStation for ary electrophoresis mass ive detection revision 1 or later gt ChemAccess C S remote instrument control revi sion A 02 01 and e Agilent ChemStation Plus Method Validation Pack A 02 01 Technique Average file size kB 2D GC LC 50 3D LC 60 3D LC MS 750 3D CE 600 Table 5 Average raw data file size by technique Agilent ChemStore C S Working with Agilent ChemStore C S 1 Data transfer The Agilent ChemStation Plus concept consists of different soft ware components designed for the various tasks in the chromato graphic laboratory The Agilent ChemStation manages data acqui sition and data analysis and the Agilent ChemStore C S database offers advanced data and result management along 7 sample informatior such as data organiz result calculations and archiving This a clear separation and advanced resul offers unmatched c and traceability by data history Res ChemStore can onli review or after review COMDPIELION locked and pending for archival while results in ChemStation are under rework It is therefore very important to have a secure and documented data transfer between the software application The specifications will offer a detailed outline of the data transfer including security measures for both directions To further manifest this separation between rework and review results can be locked from further modification when giving an approval
263. n Plus Security Pack The ChemStation Plus Security Pack G2183AA is a module of the Agilent Plus Series designed to support the requirements of 21 CFR Part 11 In the Agilent ChemStation the ChemStation Plus Security Pack modifies data analysis and provides advanced data management with regard to Network The softwar ly tested for standard ne of the Wind software wl as other net computer aj and adherin to arerecommrere ed programming practices of the Microsoft Windows operating environments These products enable the ChemStation to share physical devices such as plotters and printers with other laboratory computers as well as sharing infor mation such as data files and methods supporting the requirements for electronic records and elec tronic signature The specificati ons for this product can be found in the Agilent Chem Station Plus Specifications Note This module requires ChemStation B 2 01 SR1 Example Only see your originals shipped with the product or handed over by the Customer Engineer TOO EE WTA the centralized software installa tion relieves the burden of man aging many copies of the same Agilent ChemStation installation in one work environment Documentation The documentation set has spe cific components designed for e installing the Agilent ChemStation software using the Agilent ChemStation software understanding the principles of how the software works and
264. n contained in this document is subject to change without notice Agilent Technologies makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose Agilent Technologies shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material Agilent 1200 Series Qualification Workbook Overview 1 Agilent s line of proven qualification products and services Agilent has been a worldwide Compliance leader for two decades The unmatched experience of our experts goes into each of our compliance services Agilent can provide you with the compliance tools knowledge service and support necessary to keep your lab operatiing smoothly and efficiently For an overview refer to the brochure Can you take the heat Dont get burned by compliance On the next pages you find the brochure Agilent 1200 Series Qualification Workbook Can you take the heat Don t get burned by compliance AS Agi Ag 7 The one source solution for qualification and validation Compliance is a necessary and demanding load on a lab s resources If not well managed and implemented it can become a growing inferno which can lead to severe penalties and financial consequences In addition compliance standards are constantly evolving and therefore create a
265. n how to log an instrument service call Q Sales Order Number Q Service Order SO Number Q Date completed i Cd CN ER Q Explain support serv Advise customero Example Only QI pace e cecil 5 29 YO DI sie le S following useful Ag shipped with the product a or handed over by the asi few Customer Engineer Exclusive offers www agilent com chem exclusiveoffers Library http www agilent com chem library Education www agilent com chem education eSeminars www agilent com chem eseminars Software Status Bulletins and Patches www agilent com chem techsupport Supplies www agilent com chem supplies Tech Support www agilent com chem techsupp Issued Feb 2006 Rev 6 0 Copyright 1995 Agilent Technologies WAD Product Support Agilent Technologies Page 6 of 6 3 Installation Qualification 10 Phase Agilent LC and CE ChemStation Software G21 0BA G2171BA G2175BA G2180BA G2185BA G211601BA G2172BA G2205BA Software Installation Checklist B 02 0x Agilent 1200 Series Qualification Workbook Agilent LC and CE ChemStation Software ES Agilent Technologies G2170BA G2171BA G2175BA G2180BA G2185BA G1601BA G2172BA G2205BA te Software Installation Checklist B 02 0x Purpose of Installation 1 Installation Checklist generic 2b Installation Checklist To ensure that instruments and systems Non Bundle system if applicable are correctly installed and functioning Unpack and verify c
266. n of requirements quantitative limits for the statistical results of the tests by the responsible validation person This step must be repeated for each new validation and will require different limits for each validation experiment Method Validation Pack maps this step with a set of advanced statistical calculations The calculations offer simple summary statistics RSD RSD and linear regression statistics as well as a set of advanced calculations for outlier detection trend tests and many more For each criterion a different set of statistical calculations on the result values is performed based on the test requirement The administrative user defines the calculation limits transferring analytical requirements into 39 quantitative result criteria Method Validation Pack offers tests such as Neumann trend tests and Outlier tests e g according to Dixon and many more to provide and document an assessment of the quality of analytical separations Method validation is an iterative process Through the course of the validation it might turn out that some acceptance criteria need to be revised or even that the whol method of analysis is not suitable for solving the analytical problem si To support this approac Validation Pack allows and manage multiple ve the same validation Step 3 is to construct tl validation report includ validation data results statistics graphics and information such a
267. n revision A 10 01 or later e Microsoft Internet Explorer 5 5 or later e Microsoft data access compo nents MDAC 2 8 will be installed on your system If you already use a later version of MDAC or for compatibility reasons require a previous ver sion please contact your Agilent support representative for compatibility information Example Only see your originals shipped with the product or handed over by the Customer Engineer J e the Store in Addition settings of the study to which the run is assigned see table 4 on page 7 and e use of custom fields e database backup requirements Approximate size minutes per run KB 6 10 30 40 6 80 6 190 6 300 Client storage requirements for result only data storage Typical runs use approximately 10 KB for a short report with four peaks and use up to 300 KB per run for an extended performance report with 20 peaks Table 1 helps calculate the amount of hard disk space requirements Additional information on this topic may be found in the Agilent ChemStore C S Installation man ual and the Concepts Guide Note 5 tandalone database size is d to 800 MB due to some size limitations in the under file format To ensure opti performance for later data v Agilent strongly recom s not to exceed this data size limit If a larger single ase is required Agilent umends that the client server _n of the product be pur chased The client server d
268. n up to four user defined spectral libraries based on peak or target com pound identification Interactive Spectral Processing Users may graphically select spec tra from a chromatographic signal for visual inspection and printing The spectra are displayed in a sep arate spectral window and may be overlaid for comparisons The user can select spectra in the fol lowing modes e individual spectrum e peak apex spectrum see your originals shipped with the product or handed over by the Customer Engineer interactively ON a peak Dy peak basis for all the peaks from a cer tain data file or automatically at the end of each analysis as part of the method Users may optimize peak purity processing for accura cy or performance by setting pref erences relating to e the number of spectra used over a peak e the wavelength range used for the purity determination e the reference spectra e the purity threshold e spectral processing including logarithmic smoothing and splining factors and derivative order The purity components are calcu lated and displayed These include the spectra the spectral differ ences the signals a signals based ratiogram similarity and threshold curves Similarity curves give the most detailed information about a peak s purity User selected or average spectra are compared with all the other spectra acquired during the peak s elution and the resulting spectral comparison fac t
269. nal for shutdown of pumping system Low voltages in major maintenance areas Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 7 Performance Specifications of the Agilent 1200 Series Binary Pump SL continued Type Specification Comments GLP features Early maintenance feedback EMF for continuous tracking of instrument usage in terms of seal wear and volume of pumped mobile phase with pre defined and user settable limits and feedback messages Electronic records of maintenance and errors Housing All materials recyclable For use with flow rates below 500 pl min or for use without damper and mixer a vacuum degasser Is required All specification measurements are done with degassed solvents Physical Specifications Table 8 Physical Specifications Type Specification Comments Weight 15 5 kg 34 Ibs Dimensions 180 x 345 x 435 mm width x depth x height 7 x 13 5 x 17 inches Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption G1312B 160 VA Maximum Ambient operating temperature 0 55 C 32 131 F Ambient non operating 40 70 C 4 158 F temperature Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase Table 8 Humidity Operating altitude Non operating altitude Safety standards IEC CSA UL EN Physical Specifications continued lt 95 at 25 40 C
270. nals GIATTA Oty number of named users 5 included with the Ag ChemStore C S serve OT han ded OVET by the i i a ui Refer to table 6b for Custo mer En gineer ERA ui 20 Qty number of clients connected to the server 1 line data acqui sition Lnemstation plus an additional ottline Lnemstore license for offline data review ChemStation Plus client upgrade software upgrades a single ChemStation G1657A Plus client to the latest software revision Requires valid software licenses and ChemStation upgrade software G1656A ChemStation Plus server upgrade software G1655BA Upgrades ChemStation Plus server software to the latest revision Includes G1656A ChemStation software upgrade Requires valid software license Table 6b Agilent ChemStore C S client server version i Agilent ChemAccess C S Product description HP 1090 Series and 1050 Series Agilent ChemAccess C S is a Agilent 1100 Series Agilent CE client server application which system Agilent 5890 6850 6890 facilitates the secure and con ae i trolled integration of Agilent ChemStations into a networked system Agilent 1100 LC MSD environment by enabling users to system Agilent 35900 A D converter e provides flexible centralized data organization features which allows Agilent ChemStation files to be auto e monitor and control instru ments from any client on the network for the following instrument modules Example Only E Che
271. name when performing the one time conversion from Rev A xx xx in the new system To maintain backwards compatibility it is rec ommended to save converted files with a name different to the origi Example Only see your originals shipped with the product or handed over by the Customer Engineer data into the ChemStation sequence This process can be automated using the ChemStation macro language In addition the user interaction nest their macros and schedule and exchange data with other MS DOS or Microsoft Windows appli cations More information on customiza tion is available in the Macro Programming Guide within the Agilent ChemStation online help nal Rev A xx xx file or B 01 0x This preserves the original Rev A xx xx file which can continue to be used with ChemStation Rev A xx xx or B 01 0x systems if desired ce allows manual or fully ated export of sample and information The XML a files provided with the re allow an easy adaptation interface for a specific or knowledge Management A1 More information is avail able in the Agilent ChemStation XML interface users guide G2170 90223 Automation The ChemStation can execute multi method sequences All data generated during a sequence is stored in a unique sequence container along with the actually used methods The pat tern used for naming of the sequence container can be config ured to contain a combination of for example date time
272. nce and errors Housing All materials recyclable Physical Specifications Table 14 Physical Specifications Type Specification Comments Weight 17 kg 39 Ibs Dimensions 180 x 345 x 435 mm height x weight x depth 7 x 13 5 x 17 inches Line voltage 100 120 or 220 240 VAC 10 Wide ranging capability Line frequency 50 or 60 Hz 5 Power consumption 220 VA Maximum apparent power 75 W Maximum Power consumption active power Ambient operating 4 55 C 41 131 F temperature Ambient non operating 40 70 C 4 158 F temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Non operating altitude Up to 4600 m 14950 ft For storing the binary pump Safety standards IEC CSA Installation Category II Pollution UL Degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Injection Systems Specifications G1329A Autosampler 100 ul metering head Performance Specifications Table 15 Performance Specifications Agilent 1200 Autosampler G1329A Valid when standard 100 ul metering head installed Type GLP features Communications Safety features Injection range Replicate injections Precision Minimum sample volume Carryover Sample viscosity range Replicate injections per vial Sample capacity Injection cycle time Agilent 1200 Series Qualification Workbook S
273. nd systems are available Installation sites sk be prepared in accordance wil following specifications Important Information If you have problems in providing any of the following please contact your local Agilent office for assistance Assistance with user specific applications may be provided but should be contracted separately Users of the instrument should be present throughout the installation and familiarization otherwise important operational maintenance and safety information may be missed Additional Information For detailed steps to perform an upgrade installation refer to the Upgrade Preparation Guide for Rev B 02 01 ChemStation P N G2170 90226 Issued Feb 2006 Rev 1 0 Procedure Checklist Software Requirements QI E E E Windows 2000 Professional SP4 or Windows XP Professional SP2 Administrator logon required to the ChemStation PC TEMP variable points to an existing directory e g TEMP C TEMP Check if a printer driver is installed Example Only see your originals shipped with the product or handed over by the Customer Engineer QI Microsoft Windows compatible pointing device Pentium IV processor operating at 1 5 MHz or higher for LC LC MS and GC systems At least 512 MB of RAM for 2D instrument configuration 3D instrument configuration LC MS instrument configuration instrument configuration with ChemStore C S CD ROM DVD ROM drive Hard disk with
274. nd well plates with closing mats Droplet setup mode The tip of the fraction collector needle will initially move down to the bottom of the well Then it will slowly move upwards while the fraction is collected The droplet setup mode enables the fraction collector to collect small fractions without bubbles 4x well plates full tray MTP e 2x well plates std tray 10 funnels with external containers 1 half tray e 2x well plates std tray MTP 10 x 2 ml vials 1 half tray 100 x 2 mlin std tray 1 half tray 3x40 x2 mlin half tray e 3x40 funnels in half tray 3x15x6mlin half tray Full tray with 40 test tubes 30 mm OD max height 48 mm 20 ml vol e Full tray with 60 test tubes 25 mm OD max height 48 mm Full tray with 126 test tubes 16 mm OD max height 48 mm e Full tray with 215 test tubes 12 mm OD max height 48 mm Installed trays are automatically detected and identified Installed plates and vials can be detected when operating in the needle into location mode max height can be extended by using the short needle assembly G1364 87202 2 Agilent 1200 Series Qualification Workbook Design Qualification DO Phase Table 33 Performance Specifications Agilent 1200 Series ANALYTICAL SCALE Autosampler G1364C continued Type maximum tube plate height Maximum tube volume Maximum flow rate delay volumes ul delay calibration sensor diverter valve cooling
275. ndependent institute with approved methods The tests were performed with Methanol BIA Nr 7810 and Acetonitrile NIOSH Nr 1606 Evaporation of these solvents into the atmosphere when operating the degasser was below the limits of detection Physical Spesificarions Table 46 Physical Specifications Type Specification Comments Weight 7 kg 15 4 Ibs Dimensions 345 x 435 x 80 mm width x depth x height 13 5 x 17 x 3 1 inches Line Voltage 100 120 or 220 240 VAC 10 Wide ranging capability Line Frequency 50 or 60 Hz 5 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 46 Physical Specifications continued Power consumption 30 W Maximum Ambient Operating 0 45 C 32 113 F see User manual Temperature Ambient Non operating 40 70 C 4 158 F Temperature Humidity lt 95 at 25 40 C 77 104 F Non condensing Operating Altitude Up to 2000 m 6500 ft Non operating Altitude Up to 4600 m 14950 ft For storing the instrument Safety Standards IEC CSA Installation Category II Pollution for indoor use only UL Degree 2 This temperature range represents the technical specifications for this instrument The mentioned temperatures may not be suitable for all applications and all types of solvents Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase G1316A Thermostatted Column Compartment G1316B Thermostatted Column Comp
276. ne should NOT be performed at this time Q An Autotune should be run after the system has been allowed to thermally equilibrate for at least 11 hours following a system vent During this time it is not unusual for the instrument to exhibit mass assignment shifts poor peak shapes and or poor resolution Issued Nov 2005 Rev 3 0 Copyright 2005 Agilent Technologies LC MS Technical Marketing Page 3 of 3 5 Performance Qualification PO Phase Agilent 1100 1200 Series LC MSD Quad Major Interim Preventive Maintenance Checklist Agilent 1200 Series Qualification Workbook Agilent 1100 1200 Series LC MSD Quad Interim Preventive Maintenance Checklist Sul des Agilent Technologies Purpose of Procedure G1956A B and G1946A B C D Q Check manually that you have tune Preventive maintenance is a factory peaks in positive and negative mode recommended procedure designed to D Record instrument model no Generate tune reports in positive and reduce the likelihood of electro mechanical mm negative mode failures Failure to perform preventive maintenance may reduce the long term Q Record instrument serial no O Add results to PM documentation reliability of certain instruments and systems Two PM s per year are recommended the Major PM service i Service Review IL b f d llv with Q Record current vacuum readings ee O Rough Vacuum Q Record in the Instrument Logbook Interim PM performed 6 months after ne hatan Interi PM wasperior
277. ned drift value full scale detector output at 0 05 mA or 500 mA the signal polarity and the temperature of the solvent ther mostat 20 to 60 C The Agilent 1200 1100 Series variable wavelength detector VWD may be programmed with a single detection wavelength Data acquisition rates may be pro grammed for peak widths from lt 0 12 up to 8 00 seconds The VWD can be programmed with a timetable to change the wave length and perform wavelength scans during the course of an ana lysis The Agilent 1200 Series multiple wavelength detector MWD SL INTOREON naan npn 3 nes accorti Example Only see your originals shipped with the product or handed over by the Customer Engineer LCLLLUCLALULLY The Agilent 1200 1100 Series multiple wavelength detector MWD G1365A or G1365B can simultaneously acquire up to five chromatographic signals each with independent reference wave lengths and bandwidths The sig nal acquisition rate may be set for peak widths between 0 1 and 16 seconds During the course of an analysis the MWD can be pro grammed with a timetable to change wavelengths bandwidths and peak widths for all five wave lengths The optical unit temperature of the Agilent 1200 1100 Series refractive index detector RID can be set between 20 and 55 C The signal acquisition rate may be adjusted for peak widths from lt 0 12 up to 8 seconds During the course of an analysis the RID can be programmed with a
278. neer Q Setup the universal interface box CAN Analog In if used O O O O GPIO Analog In if used Relay Contacts if used Note Agilent LAN connection is made between one 1 of the Agilent 1200 Series System modules and the Agilent ChemStation PC If a detector is installed connect the LAN to this module Issued Feb 2006 Rev 6 0 Copyright 1995 Agilent Technologies WAD Product Support Page 4 of 6 Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist G2408 Instant Pilot Q Section NOT Applicable SN FW Q Set up the control module O Connect via CAN to Q Section NOT Applicable Software Installation Un Bundled Q Section NOT Applicable Software Product available instrument module Software Software Installation Bundled Software Product Software Revision QI E D Start Windows Start ChemStations Licenses and add tk numbers You find numbers in the Sof Certificate and Reg Packet envelopes Configure TCP IP iv instrument will be connected using LAN If necessary install and Configure IO Libraries LC MS If necessary install and Revision Q Start Windows Q Install ChemStation using the ChemStation Installation guide for reference LY Check if a printer driver is Example Only see your originals shipped with the product or handed over by the Customer Engineer CONTIEUT AGILENT BOO connect
279. ng is completed users can start with the data entry This is the first step involving experimental result data and following the planning phase Method Validation Pack offers three types of data input 1 Automated data upload from the ChemStore database Users select to load study data from te ChemStore study created r the validation and all data e automatically imported as onfigured in the planning nase and described in the revious section ata import for all result data at is not created by the hemStation and managed in ne ChemStore database e g ata from non Agilent instru ments generated during rugged ness testing The system comes with an import filter function allowing for an automated data import For details see the separate section on data import below 3 Manual data entry for all data that are not created on a computer system e g pH values the system allows for a manual data entry Data import Data import uses an import assis tant which helps users to import data from external result summary files typically in spreadsheet formats It imports various file formats such as CSV TXT Microsoft Excel and any other ASCII formats where the file extension has to be specified if it differs from ASC or TXT The import assistant displays a definition dialog enabling Method Validation Pack to automatically load this summary data to its data input grids The following definitions can be made e name
280. njection valve and mn Compartment if installed gt purge valve rm built in leak test Pass Fail Pass Fail Pass Fail G1376A Capillary Pump G2226A Nano Pump E Record serial number Firmware IQ attachment form must u Remove and disassemble pump be filled out and appended to the head s a lead instrument IQ Q Remove and clean plungers beads Q Clean support rings Firmware Updated __ YES O Remove old seals clean piston ci Mn chambers and rep lace seals Q Remove old seals clean piston O Ifthe seal wash option is installed chambers and replace seals Q Check instrument logbook and remove and replace wash seals and D Reassemble pump heads and install exclude maintenance on recently gaskets Replace the seal wash on metering drive serviced items pump cassette if the NEW active a Coiothe Normal Mode and QO Perform general inspection of each seal wash is installed perform a seal wear in procedure LC module Q Reassemble pump head s and for standard seale ONLY Q Check that each waste tray and install on metering drive O Replace PTFE Frit gold seal and interface is properly mounted O Perform seal wear in procedure for plastic cap in purge valve if the standard seals ONLY Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 1 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist pump is used in Normal Mode Q Replace the sieve gold sea
281. nly see your originals shipped with the product or handed over by the Customer Engineer 1 SN FW 2 SN FW 3 SN FW Q Setup the autosampler s O solvent inlet outlet waste drain must be in a straight line down no bends kinks or curves large volume tube if installed BCD output if installed remote control if used relay contacts if installed CAN O O O O O Copyright 1995 Agilent Technologies WAD Product Support yee Agilent Technologies e O Agilent LAN see note The following section applies if a G1330B ALS Thermostat is installed together with any of the well plate autosamplers or fraction collectors to generate a G1329A G1330B Thermostat ALS G1364B C D G1330B Therm Fraction Collector G1367B G1330B Thermostat High Performance Autosampler G1377A G1330B Thermostat Micro WPS G2260A G1330B Thermostat Preparative ALS 30B ALS Thermostat Section NOT Applicable N FW N FW N FW Setup the ALS Thermostat s underneath the module s that has have to be thermostatted WARNING Do not connect the ALS thermostat cable while the line power is connected to the any of the modules This would damage the sampler or fraction collector and the thermostat electronics O air channel adapter and plate O ALS thermostat cable O ALS thermostat waste drain G1316A Column Compartment Q Section NOT Applicable SN FW Page 2 of 6
282. nstrument e A maximum of three instru ments are supported per PC when ChemStore is installed e A maximum of three instru ments are supported per PC when spectroscopy instruments are configured e An Agilent 1200 1100 Series LC MSD system only allows one additional Agilent 1200 1100 or 1090 Series II HPLC instrument Example Only see your originals shipped with the product or handed over by the Maximum Nu The guideline for the maximum number of modules that may be configured per Agilent Chem Station PC is 18 Approximately 12 analytical modules can be config ured but this depends on the exact configuration Note Please contact your Agilent Technologies representative to confirm whether configurations approaching this 12 module limit are possible Customer Engineer Out of these 18 modules up to six CAN slave modules can also be configured e g values or UIB interfaces For correct configura tion of specific instruments and modules please contact your Agilent Technologies representa tive The ChemStation Plus Ordering Guide provides additional details on supported configura tions instrument may be configured on the same PC No additional instruments are supported on the CE MS ChemStation sys tem CE ChemStation can co reside with a second system either LC or CE ChemStation however coexecution of the software is not supported IEEE 488 GP IB Support Matrix Instruments Supported on GP IB
283. ntry Storage of external documents Users can store any external document with the validation The document must be available as a file with an extension that allows direct read out and data display This is particularly useful for adding master methods sample preparation and other method related information to the validation During printing all external documents can be integrated into the final validation report The storage capability of external documents in the method validation database allows using the Method Validation Pack soft ware as a container for all method validation related data see also the section on the DMS on page 62 Store method Store method allows adding the method as a text file to the validation database The method must be in file format and can not be a folder or anything else that can not be opened with a standard editor Component configuration ckpoint configuration level under the top level mponent level The nt typically relates or in ChemStation ogy to a compound in a m but it allows having components for one peak _ rform result comparison or result copies Usage of multiple components per peak is mainly used during method development During component configuration the user may specify a unique name for the component along with the checkpoints that will be executed for this component Checkpoints are either created according to a user selection or can be based
284. nvididual checkpoints During the submission the sequence can be assigned to a specific owner or made available to all users To minimize the an necessary data and some checkpoints suitable the same 1 This function can b the MVS export opt For the ease of use Validation Pack prc that proposes whic suitable for sharing decide per checkpc _ not to share the result data as shown in figure 33 Method Validation Pack transfers these sequences to the ChemStation for data acquisition and data analysis The sequences can load into an Agilent Method Validation Pack ChemsStation system and run similar to other sequences in the Agilent ChemStation The results of the method validation sequences are stored automatically in the ChemStore database Each validation corresponds to a separate ChemStore study If a validation sequence failed it can be resubmitted and rerun Or if only parts of a validation sequence need to be repeated for example 42 E Overview gt a MICI final test 3 MS Giethylphthalate Precision Tecision MYS Status Create study and MVS for ChemStation plus Validation Name final_test Study name r Cnickel User Data Wizard Source checkpoint Available Checkpoints destination Copy of diethylphthalate Precision Copy of diethyIphthalate Accuracy settings A EE Son a Lul nev Example Only See your
285. o distinct identi HW Run time 11 5 2003 3 22 31 PM Sample Name lsocratic Std 1 fication components such as an identification code and a password Uriginal path C AHPCHEMM ADATA DEMO005 0103 D Number of runs to be approved 1 Approvallevel First level fe Second level Approval of results pm Reason for anno vino A run The ChemStation Plus Pack protects all activit Examp a O n ly create modify or delete SAN n records with user privil See VO UT or y ina 5 electronic signatures S Eee x RES approval is a privilege Shipped with the product be configured and grani E Specie ay ms system administrator al DI h an d ed OVET by th fore limited to certain u Cu stomer Engineer Signing runs for approv rejection always promp or re identification and password confirmation of the signer for each ee ee Preconfiqured approval comments run plus a mandatory comment for eee ene ee M Mult level approval the sign off as shown in figure 23 The signer has to be the currently logged on user And Runs will be locked ChemStation Plus provides three never levels of approval tied to two mice separate user permissions to support the typical approval work on thirdlevel approval flow in an analytical laboratory It Re can be configured on a study level The Lims export will start whether multiple approval levels never should be applied or not The after first level approval ap
286. o install more than one instrument repeat the preceding Q Start ChemStation gt Add Licenses step and add the license numbers You find these numbers in the Software UJ Use the Configuration Editor and Certificate and Registration Packet configure your instruments envelopes Install Agilent LC Diagnostic Tool Q Install the Agilent BootP Service program if the instrument if Q Close all Windows applications necessary for LAN connection or close Windows and restart the computer LJ Install the IO libraries if the instrument will be connected using GP IB Q Use the Configuration Editor and configure your instruments Q Install Agilent LC Diagnostic Tool Issued Feb 2006 Rev 5 0 Copyright 1995 Agilent Technologies WAD Product Support Page 1 of 2 Agilent LC and CE ChemStation Software ES Agilent Technologies G2170BA G2171BA G2175BA G2180BA G2185BA G1601BA G2172BA G2205BA Pi Software Installation Checklist B 02 0x 3 Installation Checklist generic LJ Start ChemStation gt Installation Qualification to ensure correct installation L If there is an online instrument start the appropriate Online Instrument ChemStation L If there is no online instrument start the appropriate Offline Instrument ChemStation Q Start the Agilent Ld 4 Tool and verify con Example Only 4 If Familiarization is see your Ugn als performed shipped with the product or handed over by the L Explain how to use I
287. ocumented preset limits For example users could inject a well characterized standard five or six times and then compare the standard deviation of the amounts with a predefined value If the limits of detection and quantitation are critical users should test the lamp s intensity profile or the baseline noise Maintenance Checklists Early Maintenance Feedback and Maintenance Logbooks Users of equipment are required to develop an ongoing maintenance and calibration program The idea of the preventive maintenance is to avoid instrument failures If in FDA regulated pharmaceutical quality control laboratories a specific analysis is out of specification for any reason it is no longer acceptable to just adjust a few parameters to repeat the analysis and average the results For each out of specification analysis a failure investigation has to be done 4 Therefore laboratories do their utmost to maintain instruments such that false results are avoided Agilent 1200 Series Qualification Workbook Overview 1 The AGILENT TECHNOLOGIES 1200 Early Maintenance Feedback EMF system informs the user when actual usage level have exceeded their user specified limits Examples are e usage of detector lamps e mobile phase usage and wear counts e number of injections In addition maintenance activities can be performed by trained customer engineers on a timely basis The maintenance activities should be documented in the electronic loog
288. ods The control file for this operation is called a sequence and holds the Example Only see your originals shipped with the product or handed over by the Customer Engineer DS ULEIILEILL SUCIL ds Ue Udld LIE name injection date and time sample name and tables Tables are used to hold different types of data as one block of information For example the quantification process in a calibrated method constructs a quantification table that contains peak numbers com pound names compound amounts and retention times Like other parts of the registers tables may be user defined and have the functionality of database tables with the additional benefit of being directly associated with the base piece of analytical infor mation from which they were derived Each register may hold informa individual sample information as well as references to the appropri ate methods user for data acquisi tion data analysis and automatic recalibration specifications 1 lences and methods and definition for the lon software lifferent purposes As nalytical data the regis ter data model is used for holding configuration information and analytical methods They may be saved as files on non volatile stor age and reloaded into the ChemStation memory printed and plotted to the screen or a hard copy device Their binary format means they are not editable out side the ChemStation and each data item may also be protected
289. of user display name along with the user name the database name and the PC host e name Each revision of each file e can be recreated and reopened Server Current DMS local ical Created by O press ai Change Ute Bober Document Creation date M2 Demonstration Substance ID Demonstration Substance c SI e Robe A DOC OVERALL REPORT C vers 00001 11 42 53 AM 6 2 2004 GMT 01 00 saved by Ute C vers 00002 7 02 56 PM 6 2 2004 GMT 01 00 saved by Ute B D Md DOC OVERALL SUMMARY REPORT C vers 00001 6 51 44 PM 6 2 2004 GMT 01 00 saved by Ute B sia PDF C vers 00001 6 53 50 PM 6 2 2004 GMT 01 00 saved by Ute B Dt MVS DEMONSTRATION SUBSTANCE AE ve vers 00001 10 32 53 AM 6 7 2004 GMT 01 00 saved by Ute Ml O vers 00001 La 33 sione Abi ll Ie li ae a Ute vers 00002 10 34 36 A T 01 00 by Demonstration Substance Figure 49 DMS Server local A bi reason for check in check in date and date of parent entry i e base node entry Document Demonstration Substance EEE Original path E Program Files amp gilent Technologies Method Validat Purpose Name Label manual revision Properties Version 2 Login from local UB CLIENTI Type VDB Username Ute Bober Size 786432 Reason Validation data updated Chk 7103 Checkin 70 34 36 AM 6 7 2004 GMT 01 Status normal Parent date 10 33
290. ollowing consumables only if a column switching valve is installed G1316A 055 1200 Series 2PS 6PT or G1316A 057 1200 Series 2PS 10PT Valve options x Agilent Technologies 1x Rotor seal 0100 1854 Tefzel for valve opt 055 or 1x Rebuild Kit 0101 1359 Rotor Seal and Stator Face for valve option 057 G1157A G1158A G1159A G1160A G1162A G1163A 1200 Series Valves This maintenance procedure requires the following consumables Ix Rebuild kit na ne cui 1x Rebuild kit E 0 A 1x Rebuild kit xample UNIV A lx Rebuild kit see your originals A 1x Rotor seal x i 1x Rotor seal shipped with the product or handed over by the Detectors G13 i MWD G1321A FLD and G1362A Ri Customer Engineer The maintenance procedure requires NO consumables G1364B C D Fraction Collector This maintenance procedure requires the following consumables Inlet waste tubing and valve to needle tubing kit G1364 68712 for AS fraction collectors G1364A 050 and G1364C or G1364 68711 for PS fraction collectors G1364A or G1364B Capillary assembly for G1364D Micro Fraction collector G1364 87304 25 micro m ID or G1364 87305 50 micro m ID or G1364 87306 100 micro m ID Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 11 of 11 5 Performance Qualification PO Phase Agilent 1200 Series Liquid Chromatograph Scorp of Work Preventive Maintenance Agilent 1200 Series Qualification Workboo
291. olmium Oxide Glass Filter Type Hoya HY 1 Part No 79880 22711 meets the following specification of absorbance maxima positions Number Wavelength Accuracy Bandwidth 361 0 nm 1 nm 2 nm 418 9 nm G1306A 105C G1315A 110 Mat G1315B C 110 Example Only G1600 A VI int STA see your origin als shipped with the product G1314A B C 1100 or handed over by the 6 nm Customer Engineer 6 nm The variation in Measured wWavelengtn aepenas on the dirierent Opucal Bandwidth Agilent Technologies guarantees the traceability of the specified absorbance maxima to a National Institute of Standards amp Technology NIST Holmium Oxide Solution Standard with a lot to lot tolerance of 0 3 nm The wavelength calibration filter built into the Agilent Technologies UV VIS detectors is made of this material and meets these specifications It is therefore suitable for wavelength calibration of these detectors within the specified wavelength accuracy of the respective detector over its wavelength range January 13 2006 Engineering Manager Quality Manager Revision E 2s Agilent Technologies P N 89550 90501 A ITA Effective by Jan 13 2006 Operational Qualification 00 Phase 4 Customer contributed material Agilent 1200 Series Qualification Workbook 4 Operational Qualification 00 Phase Customer contributed material Agilent 1200 Series Qualification Workbook Agilent 1200 Agilent 1200 Series Qua
292. ologies liquid chromatography systems are developed and produced in compliance with the International Organization for Standardization quality standards ISO 9001 refer to ISO 9001 certificate in chapter Design Qualification DQ Phase and in accordance with the specifications of AGILENT TECHNOLOGIES Life Science and Chemical Analysis Group life cycle document The life cycle concept for product development and validation is common in many engineering and manufacturing fields and was proposed by the American National Standards Institute ANSI the Pharmaceutical Manufacturers Association PMA the US Environmental Protection Agency EPA and the International Organization for Standardization ISO Software products are in addition developed and produced in compliance with ISO 9000 3 as a guide refer to itgs certificate in chapter Design Qualification DQ Phase Prior to shipment to the customer each AGILENT TECHNOLOGIES 1200 Series hardware module is verified in the factory and is shipped together with a e Declaration of Conformity figure 2 which declares that the instrument has successfully passed all production quality tests Declaration of Conformity according to ISO IEC Guide 22 and EN 45014 This document states that the product conforms to the safety and electromagnetic conductivity specifications and carries the CE marking Agilent 1200 Series Qualification Workbook Overview eS Aoi DECLARATION OF CONFORMITY
293. om any kind of delimited text file Example Only see your originals shipped with the product or handed over by the Customer Engineer e Calibration samples are used to recalibrate the quantification component of the method as described below and e Control samples are evaluated against the limits for each com ponent defined in the method If the results lie outside any specified parameter range the execution of the sequence will be halted Calibration samples may be defined as simple cyclic or brack eted Simple recalibrations mean a recalibration occurs each time a calibration sample is defined in the sequence Cyclic recalibra tions occur at defined intervals during analysis of a series of unknowns In bracketing a series of unknown samples are analyzed between two calibration sets The quantitative reports for the unknown samples are then calcu lated using a calibration table averaged between the two calibra tion sets When re evaluating data already acquired users can specify whether reprocessing uses the original sample quantification data or new data entered in the sequence s sample table ences may be paused to run 2 injection priority samples other method then restarted put disrupting the automation les can be added to the ance table while the sequence ecuting the sequence and partial ence tables may be printed Stepping even automatically through the navigation table in Data Analysis V
294. om instruments t capable of being ir data acquisition th system or LAN On signals per instru configured if only other is available f another instrumen another timebase acquired at up to 1 Example Only see your originals shipped with the product or handed over by the Customer Engineer Additional Data Evaluation Modules The data processing capability of the ChemStation may also be expanded through the purchase of additional data processing mod ules for specific applications e LC diode array detector DAD spectral evaluation module G2180BA e Agilent ChemStore sample orga nization and results database module G2181BA LC Diode Array Detector DAD Spectral Evalu Module G2180BA e average spectrum over a graphi cally defined retention time range e range of spectra and e all spectra over a peak The user may also select how the spectra are processed when they are extracted The available options include e setting the subtracted reference spectrum or spectra e limiting the extracted wave length range e customizing the spectral and Example Only UV visible spectra acqui a diode array detector n graphically selected fror matogram signal for visu tion and comparison or used for peak purity det tions wavelength optimi and component identific through spectral libraries rre spectral library functionality can be extended to automatic identifi cation of components i
295. ommended for maximum performance and protection of your data For backup operation of the database the required disk space must be duplicated that is a 54 GByte RAID 5 configuration should have an additional 54 GByte of disk space available for database backup When calculating server memory requirements calculate 8 MB of additional memory for each Agilent ChemStore C S client For more details on setup and Create Study J Custom fields General Store in Addition m Store in Addition to Result M Chromatograms M Raw Data M Sequence MW Method Example Only see your originals shipped with the product or handed over by the Customer Engineer server soitware requirements e Windows 2000 Server with Service Pack 4 e Microsoft TCP IP network protocol e Microsoft Internet Explorer 5 5 or later for admin client only e Internet Information Server version 3 or greater IIS is integrated into Windows 2000 Server e Oracle 9i Standard Edition version 9 2 0 3 0 included with ChemStore C S server software MW Spectra for Quantified Peaks M Delete raw data from file system after transferring to database Assign Study Approval 5 x Cancel Help abase se size abase size is selected at ion time and should be hreful consideration as this wurauuect the total number of runs which can be accessed online and the frequency of archive dearchive operations Archive wi
296. ompound range specifica tions to check that quantifica tion results are not applied out side the calibrated range The method change history log allows users of a validated method to automatically record how and when a method was changed Users may add a rea son for the change to the 22 change history log The change history log is automatically stored as part of the method To prevent unauthorized access to the records it is protected by the user access scheme described below The change history log may be viewed and printed Limits may be assigned on a compound by compound basis in each method for a number of chromatographic and system performance parameters as described in the data analysis quantification section Results exceeding these parameter Example Only see your originals shipped with the product or handed over by the Customer Engineer NN SEE VOU EN EE EEES AT cCWVI 1 55 ured for restricted access through two user access levels an operator and manager level The manager level may be pass word protected and allows access to the complete Chem Station functionality The opera tor level restricts the user to key functionality and to execut ing defined analytical methods The operator level is intended for use in routine laboratories and specifically prevents users from modifying and creating new methods Method Robustness Sequence summary reports see section Data Analysis Special
297. ondition and as designed in the customer s facility completeness of shipment Install the IO libr aries if the Correct installation is the first step in ae instrument will be connected using QI Check license numbers and fill in GP IB or ensuring that instruments and systems installation documentation S N operate reliably over an extended lifetime fields if dI You find these Q Install the Agilent BootP Service numbers in the power Certificate program if necessary for LAN and Registration Packet envelopes communication Customer Responsibilities The customer should ensure that the mone ae OCR 008 installation site is prepared in numbers consist of 10 Q Start the ChemStation installation accordance with the specific 7 starting setup exe from the contained in the site preparat a gilent ChemStation CD ROM installation manual and that Exa m P 0 n ly ote A previously installed necessary operating supplies S ee yo Uro ri g na S nemStation will be updated consumables and usage depe 3 Heirs items such as paper pens et eh p d with th p ro d uct noose the installation directory available A customer repres E 1e default is C CHEM32 should be present at all times or han ded over by th pal the installation lect the instrument number to be C U sto mer M g INBET stalled the desired software for Jis Instrument and type in the Bundle system if applicable ucense number U Start Windows LJ If you need t
298. or B 02 01 ChemStation Pub ber G2170 90226 WAD Product Support Page 3 of 3 3 Installation Qualification 10 Phase Installation Qualification Installation Qualification Agilent 1200 Series Qualification Workbook Installation Qualification I0 Phase 3 Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist Agilent 1200 Series Qualification Workbook Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation Checklist Hardware Software Installation Purpose To ensure that instruments and systems are correctly installed and functioning as designed in the customer s facility Correct installation is the first step in ensuring that instruments and systems operate reliably over an extended lifetime Customer Responsibilities The customer should ensure that the installation site is prepare accordance with the speci contained in the relevant preparation document anc necessary operating suppl consumables and usage di items such as vials paper etc are available A custo representative should be f all times during the instal Note Typical installation time is 1 5 hours for a system and 30 minutes for a module If installation time was not sold for any section check that section as not applicable Installation Checklist Q Section NOT Applicable Note If one section contains multiple choices for installed Hardware please encircle all modul
299. ors are plotted as the similarity curve For a perfectly pure peak larity curve will be a line corresponding to a cally pure compound es will cause a deviation s ideal line The similarity re plotted with reference eoretically pure line and defined purity threshold larity curve gives the best on of any impurities that lin the peak as it eluted The deviation of the similarity curve from the ideal theoretically pure value is influenced by both compound impurities and spectral noise The user defined purity threshold may be replaced by a system calculated threshold curve based on the signal to noise ratio of the peak in question The noise sample may be user selected and if truly representative of the spec tral noise when the peak eluted compensates for any deviation of the similarity curve from the theo retically pure value attributable to spectral noise Wavelength Optimization using the Iso absorbance Plot UV visible spectra acquired con tinuously during an analysis can be used to determine the optimum signal wavelengths and band widths for routine detection by a signal based method The iso absorbance plot displays the acquired spectra as a color con toured map of wavelength against retention time together with areas for the display of both signals and spectra defined by the position of the cross hairs on the i lt c absorbance plot The iso absorbance ma used in four modes The iso absorbance
300. ortant Information If you have problems in pre any of the following please your local Agilent office fo assistance Assistance with specific applications may b provided but should be con separately Users of the instrument should be present throughout the installation and familiarization otherwise important operational maintenance and safety information may be missed Issued Feb 2006 Rev 6 0 Procedure Checklist Software Requirements Q Windows 2000 SP4 or Windows XP Professional SP2 Q Administrator logon required to the ChemStation PC Q TEMP variable points to an existing directory e g TEMP C TEMP Q Check if a printer driver is installed on the system O Verify that the regional settings are set to English US Hardware Requirements a All PC hardware needs to be listed Example Only see your originals shipped with the product or handed over by the Customer Engineer I dl ICdaSt J14 IVID UL KAJI LOL d SHIBIC instrument 2D or 3D configuration O CD ROM drive QO hard disk with at least 40 GB free capacity Q SVGA or better graphics adapter and monitor recommended resolution 1280 x 1024 True Color Q 82350A B GP IB card available with one free IRQ on the PC and one free PCI slot or Q LAN interface with TCP IP protocol installed and LAN card J4100A JetDirect card or G1369A LAN card for instrument available Copyright 1995 Agilent Technologies Agilent Technologies Q A p
301. ote status monitoring and control client software for 16 bit ChemStation ChemStation Plus server upgrade software Product No G1494A G1495A G1655BA Upgrades ChemStation Plus server software to the latest revision Includes G1656A 16 bit ChemStation software upgrade Requires valid software license Table 8 Agilent ChemAccess C S software 23 3 Agilent ChemStation Plus Security Pack What s new Please refer to the section on new features in ChemStore C S on page 2 Product Description The ChemStation Plus Security Pack is a module of the Agilent ChemStation Plus Series designed to support the requirements of 21 CFR Part 11 In the Agilent ChemStation the ChemStation Plus Security Pack modifies data analysis and provides advanced data management with regard to supporting the requirements for electronic records It also of procedure to sign off runs w electronic signature To supy the typical approval workflo regulated laboratory the Sec Pack optionally provides for levels of approval which can combined with run locking offers an easy upgrade for al existing ChemStation install The Agilent ChemStation Plus Security Pack is compatible with the following ChemStation modules e Agilent ChemStation for GC LC A D CE CE MS and LC MS for instrument control and data analysis e Agilent ChemAccess C S remote instrument control e Agilent ChemStore C S data organization and data storage module e
302. our enhanced system from the same familiar user inter face ChemStation Plus is a fully scaleable solution that enables you to expand your data system from single PC to instrument con figurations right through to dis tributed multi technique configu rations and client server function ality Users instruments and applications can be added with out disruption Note Some combinations marked with require ChemStation B 02 01 SRI e Agilent ChemStore Standalone Client G2181BA ChemStore Server G1410A NL CN Example Only see your originals shipped with the product or handed over by the Customer Engineer DUUULIUY LAUN Ua LOYJLALA Y Compliance with regulatory guidelines such as the FDA s 21 CFR Part 11 Dedicated Solutions for Specific Applications e High Throughput Purification Purify soft ware modules Advanced high capacity preparative LC for large num bers of samples e Agilent ChemStation Companion Provides a simple single screen user interface for GC routine analysis Automatically installed with ChemStation GC software e Retention Time Locking G2080BA Retention Time Locking soft ware for the G2070BA GC ChemStation e Integrated Headspace Con trol Software G2924AA Requires G2070BA GC ChemStation software e Analyst Software G2731AA For LC MSD data analysis Pequires LC MSD ChemStation ftware ptide Tools G2720AA MSD Deconvolution amp oanalysis SW
303. ower Users group Stores data files re loaded from Chem Store database to ChemStation batch review All members of local Admini strators or Power Users group le set by the ChemStation Plus delete full all permissions Application Security assigned individually and is not tied to any ChemStation user level See figure 16 A detailed documentation of the data review user privileges in the ChemStore C S database is in the ChemStore C S concept guide Security pack operator ChemStation operator no no yes no yes yes yes yes only in batch review no only in batch review no only in batch review no no no yes yes yes no no no Comparison of user privileges in the ChemStation Plus Security Pack and the standalone ChemStation Application security The Security Pack only allows users with a given user ID to log on to the ChemStation Plus application as shown in figure 12 Users need to be set up by the administrator to gain access At initial login users must specify their initial password in order to keep it unique to each user Protecting the application software from ur _ I during operation o separate session dali lates I see your originals e an interactive sioni should be ena before leaving unattended e or shift chang e for enhanced based automa session for other periods of short term absence from the computer The time based session lock is configured centra
304. p Lab Number of rows Number of values Y Units 1 2 6 Same number of values per lab Example Only See your originals shipped with the product or handed over by the Customer Engineer L EpCdlaADIUWY COILUILIOILS e Range of confidence reproducibility conditions x _ gt ChemStation Plus Method Validation Pack Planning Data type Height bd Additional header info Header line 1 Po Header line 2 GG Header line 3 Po Header line 4 Header line 5 Po Ring Experiment Here is tested wether the deviation of the values from the lab mean values is coincidentally and therefore there is delimitation between coincident deviations and not coincident deviations possible i Th a I ettings are preconfigured ation to useful defaults AS long as you do not have the need to enable special settings there is no need to change anything ChemStation Plus Method Validation Pack Interaction with other ChemStation Plus modules As described in previous sections Method Validation Pack interacts with ChemStation for data acquisi tion and ChemStore for result and data management Interaction with ChemStation for data acquisition If Method Validation Pack is installed in a ChemStation Plus data system ChemStation will offer additional functionality to run and execute method valida 58 tion sequences It includes two additional Method Validation menu
305. parate spectral libraries Search criteria may be specified for each library separately through a library search template that allows users to constrain the search both in the retention time and library entry identification parameters One of three search modes may be selected e Standard search mode identifies each integrated peak in the chromatogram from the library e Target analysis from the calibra tion table limits the library search to those library entries identical tion tabl further c use of th restrict such as I dow Aft tion qua accordin ibration e Target ar uses the library entries to iden tify peaks in the chromatogram that are within the RT window specified for the particular library entry This mode differs from the standard search mode in that it excludes peaks whose retention times are not covered by library entry time windows Consequently it is typically faster than the Standard search espe cially if there are many more peaks in the sample than there are entries in the library After posi tive identification quantification proceeds according to the data in the calibration table The calculation of the peak purity factor may be included as part of the library search Report styles can be selected to produce simple library search reports or a combination of library search and standard performance reports described above Spectral Data Import and Export The ChemStation spectr
306. partment temperature 35 C Agilent 1200 Series on line vacuum degasser pump and thermostatted column compartment Instrument equilibrated for 2 hours Physical Specifications Table 30 Physical Specifications Agilent 1200 Series Refractive Index Detector Type Specification Comments Weight 17 kg 38 Ibs Dimensions 345 x 435 x 180 mm width x depth x height 13 5 x 17 x 7 inches Line voltage 100 240 VAC 10 Wide ranging capability Line frequency 50 or 60Hzt 5 Power consumption 160 VA Maximum Ambient operating temperature 0 55 c 32 131 F Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Table 30 Physical Specifications Agilent 1200 Series Refractive Index Detector continued Ambient non operating temperature Rel Humidity Operating altitude Non operating altitude Safety standards IEC CSA UL EN 40 70 C 4 158 F lt 95 at 25 40 C Non condensing 77 104 F Up to 2000 m 6500 ft Up to 4600 m 14950 ft For storing the detector Installation category Il pollution For indoor use only degree 2 Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Fraction Collectors Specifications G1364B Fraction Collector preparative scale Performance Specifications Table 31 performance Specifications Agilent 1200 Series PREPARATIVE SCALE Autosampler G1364B Type Specification trigger modes Time
307. peaks in the sample to libraries of spectra derived from analytical standards The ChemStation allows users to use libraries both interactively and automatically The ChemStation can manage an unlimited number of spectral libraries each with up to as many entries as there is available system memory typical ly hundreds of entries Libraries may be loaded and searched by selecting individual spectra from a chromatogram and searching the library for the best matches The library search may be constrained by specifying a search template that allows the user to define a retention time window and include the informational data associated with each library entry Kar evample the applicable reten ne can be constrained to he library retention time entry names must start e letter B The search may be displayed on the and printed nay build their own s by analyzing known sub p under defined analytical s ra Ons creating a new library and entering the individual spectra and the information fields to describe the entry into the library Library entries may be added deleted edited viewed or printed Details of each spectrum in a library including absorbance and wavelength data may be exam ined Automated Spectral Library Search Reports Automated spectral library search reports allow users to automati cally identify and quantify unknown samples based on the positive identification from up to four se
308. pecification Early maintenance feedback EMF electronic records of maintenance and errors Controller area network CAN GPIB IEEE 448 RS232C APG remote standard optional four external contact closures and BCD vial number output Leak detection and safe leak handling low voltages in maintenance areas error detection and display 0 1 100 ul in 0 1 pl increments Up to 1500 ul with multiple draw hardware modification required 1 99 from one vial lt 0 25 RSD from 5 100 ul lt 1 RSD 1 5 l variable volume 1 ul from 5 pl sample in 100 ul microvial or 1 ul from 10 pl sample in 300 ul microvial Typically lt 0 1 lt 0 05 with external needle cleaning 0 2 50 cp 1 99 100 x 2 ml vials in 1 tray 40 x 2 ml vials in 4 tray 15 x 6 ml vials in 4 tray Agilent vials only Typically 50 s depending on draw speed and injection volume Design Qualification DQ Phase Physical Specifications Table 16 Physical Specifications Autosampler G1329A G2260A Type Weight Dimensions height x width x depth Line voltage Line frequency Power consumption apparent power Power consumption active power Ambient operating temperature Ambient non operating temperature Humidity Operating Altitude Non operating altitude Safety standards IEC CSA UL Specification 14 2 kg 31 3 Ibs 200 x 345 x 435 mm 8 x 13 5 x 17 inches 100 120 or 220 240 VAC 10 50 or 60
309. pients can CE be defined separately as well as a User Text ACCOUNT OF THE USER ABOVE HAS BEEN LOCKED PLEASE TAKE APPROPRIATE ACTION user defined message text and subject Pa EN j This function requires an Example Only J server to be running in the Sa HE i The e mail message can be See VO UF Origin als JD x ferred to the e mail server hi 4 RE IS EN i l af Vu we vo AIB Simple Mail Transfer Prote S Ip p ed with t e p ro d U ct Sent Mon 11 18 2002 7 10 PM SMTP For example this han pears Ste serve for the purpose of ir or han ded OVET by the notification on unauthoriz Cu stomer E ngineer attempts to access the dat An e mail message can be Lsseree User Ubober Ute Boner i by account lockout events in the Clienti R view Glisnt ChemStore C S database logbook ER MAREAREN figure 30 ACCOUNT OF THE USER ABOVE HAS BEEN LOCKED PLEASE TAKE APPROPRIATE ACTION This message was generated automatically by ChemStore C S Server Please do not reply fe Figure 30 Setup of e mail notification 37 ChemStation Plus Security Pack Product Options and Configuration Standalone version The standalone version provides the ChemStation CD ROM revision A 10 01 or higher and the ChemStation Plus CD ROM revision B 03 01 or higher as described in the table next to this text Client server version The client server versioi product consists of a se components that are rec implement ChemStation Security Pac
310. ple Only see your originals shipped with the product or handed over by the Customer Engineer SE e linearity e calibration function Based on the compound type all or a subset of these criteria must be met Most common compound types are e main compound e side compound e known impurities e unknown impurities It is obvious that it is not necessary to determine the limit of detection for the main compound as the amount of the main compound will always be closer to saturation than to limit of detection A detailed list of compound types and appropriate test criteria can be found in ICH and USP literature Method Validation Pack uses built in tem plates to automatically configure the method validation according to the guideline under consideration The ICH has also published a guidance on Stability Testing in New Drug Substances and Products to define the required amount of information and procedures for the submittal in a registration application for products ICH Topic Q1A The purpose of stability testing is to provide evidence on how the quality of a substance varies with time under the influence of a varietv nf environmental factors emperature humidity and to establish a re test r the substance and nded storage conditions alidation Pack does ests for short term and 1 stability testing according H guideline these test criteria step 2 comme lt ecuted This is an indi vidual definitio
311. pr does not require any user int tion such as Save Results or similar action It is complete user independent and covers following reanalysis steps e All functions in the batch review that calculate or change results such as reintegration recalibra tion method modifications for example changing compound names execution of predefined methods including manual reintegration e In the data analysis view Integrating printing reports and recalibration excluding manual reintegration Sequence reprocessing as well as all initial review tasks loading a batch from disk initial loading of a run into the interactive data analysis view always create new result versions These reanalysis tasks cover all activities of the ChemStation operator thus ensur ing that all reanalysis steps at the ChemStation operator level include a user independent versioning 30 In addition ChemStation Plus managers can perform manual result manipulation interactively in the Data Analysis view without using the batch review user interface The user independent revision management does not cover the manual reanalysis of results in the standard ChemStation data analysis view The user creates new result versions in this review function using the manual Transfer Data to Database command figure 19 Example Only See your originals command to create a new result version e drawing a manual baseline deleting a peak tangent skimming o
312. pressure chemical ionization APCI and atmospheric pressure photo ionization APPI modes of operation An extensive set of manual tune capabilities is also provided for users who wish to manually tune the Agilent 1200 1100 Series LC MSD Agilent 1200 1100 Series LC MSD Instrument Verification Computer aided operational quali fication and performance verifica tion OQ PV tests and procedures can be used to verify that system performance is acceptable on an ongoing basis Early maintenance feedback EMF tracks the status of system maintenance items and provides notification when a pre ventive maintenance procedure is due On line diagnostics enable system troubleshooting using inte grated tests System logbooks pro vide date and time stam records of runs errors lt tenance events Series LC MSD can be called directly within the diagnosis view from the Agilent 1200 1100 Series LC MSD Maintenance and Repair CD ROM The procedures include parts and materials breakdowns and clear animated step by step graphics and multimedia clips for each repair procedure Early Maintenance Feedback EMF automatically notifies the user when maintenance is required for key system compo nents such as rough pumps cali brant delivery system spray chamber and electron multiplier Example Only see your originals To perform instrument v it is first necessary to pu the relevant service fron Technologies The requi metho
313. pro vides a laboratory wide remote status and control client server data system for networked Agilent ChemStations pages 21 23 July 2004 t ChemStation Plus ty Pack designed to sup gt requirements of 21 CFR It uses a relational data ised on the ChemStore C S se for secure result data data review and elec lly signing off runs pages Fi Agilent ChemStation Plus Method Validation Pack advanced statistics module to cal culate the quality of analytical results including configuration design and execution of method development and method valida tion experiments It provides an automated printout of a complete method validation report as requested by ICH and Pharma copoeia guidelines All validation data are stored with versions in a built in relational database for full data security and data integrity and to support FDA s 21 CFR Part 11 pages 39 67 DE Agilent Technologies 1 Agilent ChemStore C S What s New With the latest revision users can benefit of new functionality in many areas as listed below Workflow e Up to three configurable levels of approval linked to separate user privileges see Agilent ChemStation Plus Security Pack Electronic signatures and password settings on page 33 Optional locking of runs after approval to prevent them from further modification see Agilent ChemStation Plus Security Pack Electronic signatures and password settings on page 33 New ch
314. proval configuration is part after aaa approval of the study settings For new after third level approval studies the settings from the global approval configuration template are m a Tm copied to the study The approval SS Canc H configuration is shown in figure 24 Figure 24 Global approval configuration template 39 The operator will typically give the first level approval when reviewing his results To allow for peer reviews the application sup ports multiple first level approvals The second level approval lies in the responsibility of the laboratory manager when signing off the results and pre vents a signed run from further first level approvals unless the run is rejected The third level approval equals a 2nd second level approval can serve as the final sign off by the qua department It requires user to have the seconc approval permission third level approval no natures can be applied run is rejected Options can be locked from rea after the approval see Which level finally lock configurable The admi assigns the permissions tor the different approval levels to the users Preconfigured approval comments The ChemStation Plus Security Pack provides the ability to globally define approval comments These comments consist of two components a short fixed text that cannot be modified nor deleted by the signer and a pre defined default text that can be changed during the signing The
315. ps in validation experi ments planning and definition of expected results experiment exe cution and result evaluation as separate tasks tied to different user permissions All steps are documented in audit trails and are fully traceable Method Validation Pack is equipped with a fully fea tured document management sys tem DMS that is used to retain and manage all versions of a vali dation including all attachments The DMS provides a powerful search engine further complement ed by the ability to tag validations with additional keywords Agilent ChemStation Plus Method Validation Pack Work Flow Configuration The configuration of validation experiments is hierarchical figure 51 The top level represents the complete validation experiment This level may include standard operating procedures SOP for sampling sample preparation description of quality and grades of solvents testing materials a description of the analytical method and so on Such information can be directly added as validation comments or enclosed as document attachments to the validation The next level introd Fa Method Validation Pack User Ute Bober local login E File Edit Validation Component Checkpoint Report View Security Deel amp 23 ct DE DES English reportla Overview lt Es d MA Sulfamethizole ME Precision RT ME Precision Area ME Calibration Function ME Linearity ME Limit of
316. r LC PC based software for control and data evaluation Analog outputs Recorder integrator 100 mV or 1 V output range selectable one output Communications Controller area network CAN GPIB RS 232C LAN APG Remote ready start stop and shut down signals Safety and maintenance Extensive diagnostics error detection and display through control module and ChemStation leak detection safe leak handling leak output signal for shutdown of pumping system Low voltages in major maintenance areas GLP features Early maintenance feedback EMF for continuous tracking of instrument usage with user selectable limits and feedback messages Electronic records of maintenance and errors Automated operational qualification performance verification 00 PV Housing All materials recyclable Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Table 29 Performance Specifications Agilent 1200 Series Refractive Index Detector continued Type Specification Comments Environment 0 to 55 C constant temperature at lt 95 humidity non condensing Dimensions 180 mm x 345 mm x 435 mm 7 x 13 5 x 17 inches height x width x depth Weight 17 kg 38 lbs Based on ASTM method E 1303 95 Practice for Refractive Index Detectors used in Liquid Chromatography Reference conditions optics temperature 35 C response time 4 s flow 1 0 mL min LC grade Water restriction capillary column com
317. r handed over by the Customer Engineer Agilent ChemSto urv The standalone version of Agilent ChemStore C S is user installable from the ChemStore C S CD ROM and can be added to an existing ChemStation installation Agilent ChemStation software family CD ROM version A 10 01 or higher The Agilent ChemStore C S Oracle client server version includes e ChemStore C S server software included on the ChemStation Plus CD ROM e Oracle 9i standard edition version 9 2 0 3 0 included in ChemStore C S server software on a set of separate CD ROMs EBIIUUIIUUIUII UILU SPY uumy e ChemStation Plus CD ROM and e ChemStore C S client software on ChemStation Plus CD ROM Agilent ChemStore C S data base migration The Agilent ChemStore C S sys tem includes a migration utility which enables you to migrate your Agilent ChemStore C S data in the following ways e Migrate Agilent ChemStore A 01 03 or B 0x 0x data stand alone to Agilent ChemStore C S B 03 01 standalone Approval configuration 4 Freconfigured approval comments Approval configuration M Multi level approval Runlockng Ap e Migrate Agilent ChemStore C S B 03 01 data to Agilent ChemStore C S server data If you are currently running Agilent ChemStore A 01 03 on your system and you wish to migrate your data to the Agilent ChemStore C S server Oracle data base you will need to migrate in two steps First migrate to the B
318. r reports exporting data into the native file format Agilent ChemStore C S also offers clipboard cut and paste for both tabular and graphical data figure 10 Report outputs can be in a file format allowing convenient publishing of reports for example HTML for internet and intranet publishing Agilent ChemSt m Section f Compound list C Chart i MS Excel 7 Ok Clipboard i Export result data to Cancel Help Figure 10 Interactive data export from Agilent ChemStore C S into other applications ChemStore C S allows printing in the following file formats e HTML format for review with an Internet browser excluding graphics Example Only See your originals The Agilent ChemStc client offers the user toolkits data reviev administration The described in the next Sample and compound review Within the data review toolkit the user has a choice of whether to see data organized by analysis also referred to as run or sample or by compound In the table layout view data is displayed in configurable tables either sample or compound centric Chromatogram spectrum presentation In the review layout view the display area can contain both graphics and a table The details differ for sample and compound review The chromatogram viewer provides for dynamic zooming and rescaling capabilities allowing a shipped with the product or handed over by the Custom
319. r version of MDAC or require bility reasons a pr please contact yo support represeni compatibility info e A printer must be configured in Win e The hard disk par that is used for in Method Validatior be formatted witl Hard disk space Standalone installation Method Validation Pack needs approximately 40 MB hard disk space for the installation files The validation database files VDB typically require 250 1000 KB each The exact size strongly depends on the size of embedded graphics If possible use vector graphics WMF format rather than bitmap graphics BMP to reduce the validation file size Using large bitmap graphics in validation comments also has an impact on the DMS size Hard disk requirements for the Oracle data base are discussed in the following Ad paragraph Client server installation The client server version of Method Validation Pack is based on an Oracle relational database The application supplies three pre defined schemes for the data base installation small medium and large The databases are separated into multiple tablespaces for better performance and administration In particular the tables storing the validation data comments can contain large graphics and those reserved for Example Only see your originals shipped with the product or handed over by the Customer Engineer versions changes to one VDB file are stored as a new version new VDB files create a new entry
320. rail optionally e a flag in the footer of the report indicating that the validation was done with a reduced level of audit trail development vali dation see page 47 Available report styles Method Validation Pack offers two report types e Normal report standard report containing detailed information e Short report compact report containing only the most important sections and omitting for example statistical details Both reports can be compiled in two different styles e Classic report standard report look e Modern report different appearance using color coded results passed fail Finally the software offers a concise summary report providing a one page summary of the gt plete validation results It tains only the checkpoint ies and the test result passed statements ort customization following elements can be figured within the Method dation Pack application port language German or nglish report fonts and sizes e graphics section line style background color for data color of axis and display of limits axis annotations and e text sections title page validation comment page report header and default planning and execution comment All text sections can also include graphics such as company logos Method Validation Pack uses a Microsoft Word based reporting engine If further customization is required it allows to open the entire method validation report as a MS Word
321. ratory or regulatory requirements for example for limit checking a sample result lying outside of a specified interval can be flagged as out of spec During the development the custom calculation is documented in a scripting window as shown in figure 8 This protocol is stored in the database as the calculation template Each new version of a template is stored with version Retention Time Functions dates 7a LI n Absolute value o E E E Count Exponential 4 5 6 Briggs logarithm Natural logarithm 2 3 1 Mean Minimum kaximum Relative stdew Square ND rn wN oT Square root Standard deviation i zzz di NULL arance i MEA ES ES i String compare LIKE OK Cancel Help nation Optionally it can be led in the report to fully ment the calculation F at Any part of the calculation or the complete template can be tested on sample data obtained by a database query Any error or inconsistency is identified and documented in the error window The related calculation piece is highlighted in the protocol for convenient and simple trou bleshooting Calculation result tables as well as charted calculation results can be integrated into ChemStore reports The user may choose whether to base a report on the latest version of a calculation or any earlier one The reporting capabilities of ChemStore C S are outlined in the followin
322. rdware erations The hardware requirements of the Agilent ChemStore C S server will Standard level Highend level 1 15 gt 15 1 1 1 2 1024 2048 2 2 2x18 GB RAID1 2x18 GB RAID 1 Controller 1 Controller 1 5 x 18 GB RAID5 5x36 GB RAID 5 Oracle Controller 2 Data Contoller 2 2 x 18 GB RAID 1 Index Log Files Rollback Seg ments Controller 1 yes yes DAT DLT tape drive DAT DLT tape drive yes yes Recommended server configurations for Agilent ChemStore C S vary based on the size of the data base selected at installation time and the number of concurrent connections the number of active instruments acquiring samples to the database and Agilent Chem Store C S review clients and the backup requirements for the serv er database Table 2 shows three recommended server configura tions In a very small networked installation with less than three clients and no need for advanced security using RAID the Chem store C S Oracle database can also run on a high end PC usi Microsoft Windows 200 software as operating s Note Planning the server dis ration is very important 12 GByte for small dat 54 GByte for large dat hard disk RAID 5 confi is recommended Using hard disk configuration ceaure dancy and striping yields less free hard disk space than RAID 0 no redundancy For example 3 disks of 9 GByte each using RAID 5 yields 18 GBytes while using RAID 0 yields 27 GByte RAID 5 is rec
323. re registered trademarks of Microsoft Corporation The information in this publication is subject to change without prior notice Copyright 1995 2006 Agilent Technologies All Rights Reserved Reproduction adaptation or translation without prior written permission is prohibited except as allowed under the copyright laws Published May 1 2006 Publication Number 5989 5055EN whee Agilent Technologies 2 Design Qualification DO Phase Agilent ChemStation Plus Specifications Agilent 1200 Series Qualification Workbook eo General Description This document provide tions for Agilent Chem Agilent ChemStation PI Pack Agilent ChemAcc Agilent ChemStation Plu Validation Pack which 2 the Agilent ChemStationi With the Agilent ChemStation Pius family you need to purchase only the features you require This can be the fully featured software package for the most advanced capabilities or you can exclude features that you may not want now and add them later as your needs change Agilent ChemStation Plus Specifications Example Only See your originals shipped with the product or handed over by the Customer Engineer Specifications Agilent publication number 5988 9925EN Agilent ChemStore C S data organizing and storage mod ule that provides a scalable in process chromatographic data organization system for Agilent ChemStations pages 2 20 Agilent ChemAccess C S remote access module that
324. re services chromatography columns packing reagents and consumables This Certificate is valid until June 1 2006 This Certificate is valid as of February 10 2006 Certified for the first time February 1 1994 Weve K L H Pierre Sall President KEMA Registered Quality The method of operation for quality certification is defined in the KEMA General Terms And Conditions For Quality And Environmental Management Systems Certifications Integral publication of this certificate is allowed KEMA Registered Quality Inc Accredited By 4377 County Line Road ANAB Chalfont PA 18914 Ph 215 997 4519 Fax 215 997 3809 CRT 001 073004 KEMAX Affiliate with the N V KEMA in the Netherlands member of the International Network for Quality System Assessment and Certification IQNet ADDENDUM To Certificate Number 510014 045 ISO 9001 2000 of February 1 1994 Valid as of October 27 2005 Valid until June 1 2006 Page one of two The Quality System of Agilent Technologies Inc Life Sciences and Chemical Analysis Group Waldbronn Analytical Division Hewlett Packard Strasse 8 Waldbronn Germany 76337 Yokogawa Analytical Systems Inc 9 1 Takakura Cho Hachioji Shi Tokyo Japan initial certification date December 28 1994 Agilent Technologies Shanghai No 412 Ying Lun Road Shanghai PRC Little Falls Site 2850 Centerville Road Wilmington Delaware Newport Site 101 First State Blvd Newport Delawar
325. rements for this application VV BEEUAWY VY Service Pack 4 or Windows XP Profession Service Pack la e Agilent ChemStation revision A 10 01 or later e Microsoft Internet Explorer 5 5 or later e Microsoft data access components MDAC 2 8 will be installed on your system If you already use a later version of MDAC or require for compatibility reasons a previous version please contact your Agilent support representative for compatibility information e A local or network printer must be installed and configured e The hard disk partition that is used for installation of Security Pack must be formatted with NTFS The standalone database size is limited to 800 MB due to some WD VJJ AI L1LWVI 7 _1I _1L1UKIKIL YY LULL e Complete change control documentation for methods and manual integration changes e Four levels of audit trails for data acquisition data analysis application tasks and security violations e Electronic signatures for each result version following the guidelines of 21 CFR Part 11 e Three configurable levels of approval _ Optionally locking of runs upon the approval to prevent them from further modification trict size limitations in the under lying file format To ensure opti mum performance for later data review Agilent strongly recom mends not to exceed this database size limit A configurable size checking tool automatically launches a warning message when the specified
326. rinter supported by the current version of the ChemStation For further information please contact your local service representative O The voltage setting of the computer system and the power cables have to be correct Detailed information on how to set up Windows XP Professional for optimal ChemStation usage is located on the ChemStation CD ROM under the manuals installation Configure and Maintain your Agilent Computer yectory lease verify if the instrument yports GPIB connection WAD Product Support Page 1 of 1 Installation Qualification 10 Phase Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2073BA G2170BA G2171BA G2180BA G2090BA G2710BA G1601BA G2201BA B 02 01 Upgrade Site Preparation Checklist Agilent 1200 Series Qualification Workbook Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2073BA G2170BA G2171BA G2171BA G2180BA G2090BA G2710BA G1601BA G2201BA B 02 01 Upgrade Site Prep Checklist Purpose of Procedure To assure that the upgrade of Agilent instruments and systems can be completed successfully by careful preparation and evaluation of the installation site and by ensuring the availability of appropriate utilities consumables and supplies Customer Responsibilities Customers should ensure that necessary operating supplies consumables and usage deper items such as columns vials syringes and solvents require the successful installation of instruments a
327. rior written permission is prohibited except as allowed under the copyright laws Published in Germany July 1 2004 Publication Number 5989 1390EN HE Agilent Technologies Design Qualification DQ Phase 2 Compliance Agilent has been a worldwide Compliance leader for two decades The unmatched experience of our experts goes into each of our compliance services Agilent can provide you with the compliance tools knowledge service and support necessary to keep your lab operatiing smoothly and efficiently For an overview refer to the brochure Can you take the heat Don t get burned by compliance see Agilent s line of proven qualification products and services in Chapter 1 Overview Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Customer contributed documents Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase Customer contributed documents Agilent 1200 Series Qualification Workbook Agilent 1200 Agilent 1200 Series Qualification Workbook 3 Installation Qualification 10 Phase Side Preparation Specification Checklist Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification Agilent 1200 Series LC MSD G1956A B G2908BA G3218AA G3218BA Site Preparation Specification Agilent ChemStation Software Modules G2070BA G2071BA G2072BA G2170BA G2171BA G2180BA Software Site Preparation Specification B 02 01 Agilent Ch
328. rkbook Design Qualification DQ Phase G1158A Agilent 1200 Series 2 position 6 port valve Performance Specifications Table 38 2 position 6 port valve Liquid contacts Port size Flow passage diameters Volume in flow passage Maximum pressure Recommended flow range Stainless steel PEEK and alumina ceramic Accepts 10 32 male threaded fittings Stator and stator face assembly 0 4 mm 0 015 rotor seal 0 5 mm 0 018 Stator includes stator face seal 0 7 ul hole rotor seal 0 3 ul groove 41 MPa 408 bar 6000 psi 0 2 100 ml min Agilent 1200 Series Qualification Workbook 2 Design Qualification DO Phase G1159A Agilent 1200 Series 6 position selection valve Table 39 6 position selection valve Liquid contacts Stainless steel and PEEK Port size Accepts 10 32 male threaded fittings Flow passage diameters Stator 0 6 mm 0 024 stator face assembly and rotor seal 0 4 mm 0 015 Volume in flow passage Angled ports 1 2 5 15 6 pl Radial ports 2 4 6 18 8 pl Maximum pressure 35 MPa 345 bar 5000 psi Recommended flow range 0 3 40 ml min The G1159A Agilent 1200 Series 6 positions selection valve can be used at flow rates up to 100 ml min but without valve switching In most cases e g column selection the valve switches during the postrun or prerun when the flow can be reduced Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 G1160A Agi
329. roduct or handed over by the Customer Engineer one data section to group data logically for example around a vial number a sample type or any other item that the user requires e restriction capabilities to focus on an adequate subset of the data that is one peak within a chromatogram and e statistical calculations selected interactively at any time during the data review from the ChemStore C S user interface e inclusion of custom calculation result tables charts of calculated values and full documentation of the custom calculations including calculation formula and calculation errors The ChemStore C S application offers an additional functionality to print the current view This func tion gives access to an immediate printout of the actual screen including all graphics without any formatting or configuration tasks For system suitability reports the calculation of system suitability parameters can be triggered independently of the ChemStation gt 10d during sample or sequence p by enabling the Calculate lt Performance checkmark run or sequence line see re 2 Agilent ChemStore C S Data Export into Other Applications Agilent ChemStore C S allows an easy export of selected database information selection by records and data fields to third party applications notably MS Excel The user has control over which fields are included and in which order This can be done based on queries o
330. rom installation to ongoing support Agilent has compliance covered Installation Qualification 10 provides validation upon delivery IQ ensures that new Agilent hardware and software is installed correctly from the moment it is unpacked to the point it is ready for operation documenting the completeness of shipping the operating environment and the components of the system Recommended times for IQ Moving an instrument to another laboratory Adding components to an instrument Installing hardware or software Installing a software patch update or other application Operational Qualification 00 ensures basic accuracy from the beginning After IQ OQ is performed to verify and document an Agilent instrument s ability to meet specified performance criteria after it is installed OQ involves a comprehensive test of the complete system using established conditions and known sample characteristics A key benefit to this procedure is to ensure the basic accuracy and precision of the instrument or system and to uncover any potential problems before they occur Agilent recommends preventive maintenance for OQ Recommended times for 00 Installing hardware or software Repairing a major piece of hardware Any software change that affect system security data Integrity or administrative controls Repair Qualification RO restores equipment validation RQ is a must for any service or maintenance performed on Agi
331. romatogram vie providing dynamic ZOO and rescaling capabiliti Agilent ChemStore C S Interface on page 15 Direct Read access to ChemStation Method s Agilent ChemStation P Security Pack Audit and Change Document on page 36 Le Variables in advanced queries for operator names and dates see Agilent ChemStore C S Working with Agilent ChemStore C S on page 10 New database field for area results from ChemStation Reporting e Powerful custom calculator for advanced calculations reporting and charting of calculation results based on fully versioned calculation templates see ChemStore C S Working with Agilent ChemStore C S Custom calculations on page 12 e Optional peak performance cal culation per run or sequence line see ChemStore C S Reporting on page 14 Open system connectivity e File less LIMS interface see ChemStore C S LIMS Connectivity on page 18 Administration e Email notification enhancements see Agilent ChemStation Plus Security Pack E Mail Notification on page 37 Configurable command line access see ChemStation Plus Security Pack User Management and Application Ca nasnea tas DOW WD OO DON Example Only See your originals shipped with the product or handed over by the Customer Engineer a aa CERZOIe It provides a means to easily organize review and approve analytical data based on study and sample information Agilent ChemStore C S supports the
332. roven qualification products and services Agilent 1200 Series Qualification Workbook Agilent 1200 Agilent 1200 Series Qualification Workbook 000 ee 2 Design Qualification DO Phase j amp r Iso 90001 Valid June 2006 Certificate e Specifications Pump Specifications Injection Systems Specifications Detectors Specifications Fraction Collectors Specifications Valves Specifications Miscellaneous Specifications Agilent ChemStation Specifications Agilent ChemStation Plus Specifications Compliance Customer contributed documents The user should feel free to add further documents e g not supplied by Agilent Technologies whenever he thinks this is appropriate Fip Agilent Technologies 2 Design Qualification DO Phase Iso 90001 Valid June 2006 Certificate Agilent 1200 Series Qualification Workbook KEMAX Affiliate with the N V KEMA in the Netherlands A member of the International Network for Quality System Assessment and Certification IQNet CERTIFICATE Certificate Number 510014 045 With two page addendum The Quality System of Agilent Technologies Inc Life Sciences and Chemical Analysis Group Americas Europe and Asia Pacific Including its implementation meets the requirements of the standard ISO 9001 2000 Scope Design development manufacture marketing distribution and support of analytical instrumentation systems and microarray systems including related softwa
333. rs not detected along with a graphical representation of the results in charts Data management and audit trails All configuration and result data along with the MVS files and vali dation reports form the valida tion It is stored in a relational database for full data integrity and to ensure data security Every vali dation modification or configura tion change is stored in the DMS database as a new version of the existing validation All changes and modifications are documented either in the program audit trail for program related events such as logon or in the validation audit trail In a server based instal lation all validation data is stored in additional Oracle tables of the same database instance as used by the ChemStore database In the Example Only See your originals ChemStation I shipped with the product or handed over by the Compatibility wi ChemStation Plu Agilent ChemStation Plus Method Validation Pack A 02 01 is compatible with the following ChemStation Plus modules e Agilent ChemStation for GC LC A D CE CE MS and LC MS for instrument control and data analysis e Agilent ChemAccess remote access and module e Agilent ChemStore data organi zation and data storage module For result management in a rela tional database Method Validation Pack requires the ChemStore data base or ChemStation Plus Security Customer Engineer application The standalone data
334. ry servo controlled variable stroke drive floating piston active inlet valve solvent selection valve and electronic flow control for flow rates up to 100 ul min 0 01 20 ul min 0 01 100 ul min with the extended flow range kit 0 001 2 5 pl min with the electronic flow control bypassed 1 20 ul min 10 100 l min with extended flow range kit 0 1 2 5 ml min with the electronic flow sensor bypassed lt 0 7 RSD or 0 03 SD typically 0 4 RSD or 0 02 SD at 10 l min and 50 l min column flow based on RT default setting 1 to 99 or 5 Ul min per channel primary flow whatever is greater lt 0 2 SD at 10 ul min 20 pl flow sensor 50 pl min 100 pl flow sensor and 1 ml min normal mode default setting Typically 3 ul from the electronic flow control to the pump outlet for flow rates up to 20 pl min Typically 12 ul from the electronic flow control to the pump outlet for flow rates up to 100 ul for flow rates up to 100 pl min and electronic flow control active primary flow path 180 480 ul without mixer 600 900 ul with mixer system pressure dependant Typically 180 to 480 pl system pressure dependent without mixer for flow rates up to 2 5 ml min Mixer delay volume 420 ul 20 to 400 bar 5880 psi system pressure User selectable based on mobile phase compressibility 1 0 8 5 solvents with pH lt 2 3 should not contain acids which attack stainless steel Upper pH range is limited
335. s m z val ues or a range of m z values The mass selective detector sig nals TIC and or EICs may be displayed along with those from detectors The software peak alignment for chro ms from different detec nected in series Full tive mass and UV visible nanipulation are available 3 selection of spectra by lual spectrum pex spectrum je spectrum over a graphi Cally defined retention time range e range of spectra and e all spectra over a peak The user may also select how the spectra are processed when they are displayed The available options include e background subtracted spectra e limiting the m z range e smoothing e normalization and e continuous curves or histogram mode Quantification All of the standard ChemStation quantification capabilities are available for use with mass spec tral data TIC or EIC signals can be used for quantification For tar get compound analysis retention time windows quantification ion signals and qualifier ion signals ratios can be defined on a per compound basis Peak Purity The LC MSD ChemStation includes all the UV visible peak purity data evalui of the Agilent dio DAD spectral e Capability for pe nation using LC 1 tral data is also ir purity may be del actively on either basis for all the tain data file or lt the end of an ana the method The user can select to interactive ly evaluate peak purity for data sets
336. s in Comma Separated Values CSV format This is a very simple format for tabular data that is accepted by many spreadsheet programs and databases Independent from the report style selected only the information contained in the report style Short will be saved There can be several DIF and CSV files for a single report For each report block the first file for ole REPORT00 CSV con he report header informa Subsequent files contain the vr results If the results are 1 by retention time only one required for the complete for example RTOL CSV If the results are 1 by signal a separate table uired for each signal In this the files are named Report01 CSV through ReportNN CSV where NN is the number of the signal XLS The report is exported to a Microsoft Excel spreadsheet in XLS format The data generally requires additional processing HTML Results are saved in Hypertext markup language for viewing in web browsers The Agilent ChemStation for CE has an additional mobility report that uses the voltage signal and the electropherogram to compen sate for the velocity of the com pounds migrating through the detector cell 17 Data Analysis Specialized Reporting Advanced reporting capabilities are also included in the 32 Bit ChemStation for users who require a more specialized set of reports These include statistics on separation quality reports that include trend analyses between sa
337. s is appropriate 1 The AGILENT TECHNOLOGIES 1200 Series Qualification Workbook contains documents for a 1200 Series system containing at least one of the following 1200 Series modules Please printout this document and put it in a binder You can add your own material to this Qualification Workbook Module isocratic pump binary pump binary pump SL capillary pump nanoflow pump quaternary pump Agilent 1200 Series Qualification Workbook vacuum degasser micro vacuum degasser manual injector autosampler high performance autosampler e high performance autosampler SL thermostatted autosampler thermostatted high performance autosampler thermostatted column compartment thermostatted column compartment SL variable wavelength detector variable wavelength detector SL e diode array detector diode array detector SL fluorescence detector LC MSD module handheld controller Instant Pilot e AGILENT TECHNOLOGIES ChemStation for LC Systems Overview Design Qualification DQ Phase Installation Qualification IQ Phase Operational Qualification 00 Phase Performance Qualification PQ Phase Agilent 1200 Series Qualification Workbook Contents 1 Overview Introduction Design Qualification DO Phase Installation Qualification I0 Phase Operational Qualification 00 Phase Performance Qualification PQ Phase Agilent s line of proven qualification products and services 2 Design Qualification DQ Phase Iso
338. s rec standard operating prot sampling analysis etc metod Validation Pack includes a variety of different reporting functions What s New With the latest revision users can benefit from new functionality in many areas as listed below Validation planning e Solution stability calculations for short term as well as long term stability studies see ChemStation Method Validation Pack Level 3 Interaction with other ChemStation Plus modules on page 58 Validation report in the report e One page summary report e Optionally color coded test results in the reports e Example Only See your originals shipped with the product or handed over by the Customer Engineer EXPOrl VI VallUatiori reports II pdf Format see ChemStation Plus Method Validation Pack Data Security on page 62 Administration Validation Pack Data Security on page 65 User documentation e Revised Method Validation Pack User s Guide and Online Help Validation Pack Checkpoint Planning on page 52 e Enhanced handling of selectivity data and calculation see ChemStation Method Validation Pack Checkpoint Planning on page 57 Validation execution e Submission of custom validation sequences see Working with ChemStation Plus Method 40 Product description Validation Pack is a data management system for all method validation data It includes advanced statistical calculations and r
339. se Integrator Capabilities The integrator algorithms include the following key capabilities e anautointegrate capability used to set up initial integrator para meters e the ability to define indi integration event tables each chromatographic s multiple signals or more one detector is used e interactive definition of tion events that allows u graphically select event e graphical manual or rub band integration of chro matograms requiring human interpretation these events may also be recorded in the method and used as part of the automated operation e display and printing of integration results e the ability to integrate at least 1000 peaks per chromatogram e integrator parameter definitions to set or modify the basic inte grator settings for area rejec tion height rejection peak Example Only see your originals shipped with the product or handed over by the Customer Engineer Data Analysis Quantification The Agilent ChemStation calibra tion mode of the data analysis view allows simultaneous display of e the signal or signals being cali brated with an indication of the current compound s retention time window e the calibration table whose dis play may be configured from a comprehensive selection of cal ibration parameters and e the calibration curve for the compound being calibrated All the calibration mode windows are linked so that changes in one are automatical
340. se two components appear during the approval The signer has to choose a fixed comment from the dropdown list box containing the pre configured comments as shown in figure 23 and can optionally enter 34 or change the free text comment The approval comments are defined by the administrator in the global approval configuration tem plate All other sensitive actions for example changing run related custom field values such as the batch ID and the archival or deletion of runs follow the same process as described above and are tied to distinct user permissions All electronic signatures are noted Example Only See your originals shipped with the product or handed over by the Customer Engineer implemented to periodically check and revise passwords and apply the company s password policy figure 25 The administrator can specify the values for these conditions e Minimum length is the minimum acceptable length in characters of a password Passwords shorter than the minimum length are invalid and rejected by ChemStore C S The default is eight characters with a valid range between 0 and 30 e Password expiry date is the number of days over which the password remains valid The password expires after the specified validity and a new password must be provided The default is 90 days with a valid range between 1 and 32000 e Password uniqueness is the minimum number of new unique passwords that a user must
341. shows the planning 9 dialog of the checkpoint linearity For proportionality the following entries need to be specified the nominal value d which describes the maximum deviation of the one point calibration from the linear regression the niveau specification limit g which is the minimum concentration where the one point calibration has to be valid and the number of Planning data e Determination method e Regression weighting measurements to be executed at the limit g Calculated parameters Lab capability sii i are Knowledge of lab cap ability En E a ELE weicnted e Sum of the x and y values necessary for accurat pe process capability s parts 33 and 11 Lab Example Only CP ear equation sidual standard deviation solute method standard not required by the F It checks for the ratic dispersion versus spe See your originals shipped with the product Lab capability occupi i i p y a i aries lative method standard ia ion rps a or handed over by the riation SAS ROSSORE C uste E Er nfidence interval of the slope refer to the analytical LUSCOMET nq meer y intercept Figure 40 shows the 4 y i ee e dialog of checkpoint nearity ee Duh COME IONE hesidudal standard devlaLion Niainod crandand dawson e Coefficient of determination 1 Planning data e Number of samples e Y
342. spread ofthe lab mean 6 values has no significant influence on the total spread of all measured values the comparative stand 7 deviation is calculated ta son to a reference Here the ruggedness is lh the help of t test F test and the nominal Figure 39 shows the p Examp i O n ly idard deviation typically the result of dialog of the checkpoi ruggedness robustnes See your originals shipped with the product e Determination metl or handed over by the Planning data e Comparison of re e Comparison with Customer Engineer e Other data i e Number of series Irom Z 5U e Y units e Multiple injections possible e Nominal value for the standard deviation Output settings for calculations e Comparison of results e Neumann trend test e Dixon or Grubbs test for outliers Variance homogeneity Repeatability limit Reproducibility limit Error of result Range of confidence repeatability conditions e Range of confidence reproducibility conditions e Test for robustness e Comparison with reference e Apply t test e Apply F test Test method dness Fi Method Validation Pack Planning g Data type Height _ batch Test criterion According to ICH Additional header info Dimension _ Run number Meas sys HPLC Header line 1 QS Number fantasy Comment Device type _ Agielnt 1100 Header line 2 s
343. stable as specified Result a Value Adjust optical balance if value gt 0 2 WAD Product Support Agilent Technologies FRACTION COLLECTORS G1364B C D Fraction Collector O 1 Record model number Q 1 Record serial number Record model number Record serial number Record model number O 3 Record serial number a 4 Record model number O 4 Record serial number O 1 Replace the inlet waste tubings 2 Replace the valve to needle tubings Q Check that the ALS Thermostat unit drain tube is positioned correctly if applicable Page 4 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist rt a ee Agilent Technologies SERVICE REVIEW handling of hazardous mobile phase is a Customer responsibility Q Ifa ChemStation is the Instrument Record in Instrument Logbook that Service Order SO Number Controller attach printouts of all a PM was performed tests completed to this Preventive Update customer logbooks and D leted Maintenance Checklist EMF sections x ate complete Q If the Instrument Firmware was Affix the PM Sticker to the 1200 updated complete the IQ system or Instrument Logbook as attachment protocol and append it specified by the Customer Q Customer Signature to the instrument IQ If the PM is being performed in Q Make atest injection of a dilute test advance of an OQPV use the mixtur e 1 drop of Acetone ina protocol as guide for Checkout and 2ml vial
344. strategy paper has been developed With this strategy paper and by working with a custamer s ChemStore C S Example Only See your originals shipped with the product or handed over by the Customer Engineer SULY LEAL LLULTLELIC VUES Udale Create Archive Query q administrator Agilent provides a consulting service to plan and implement the right backup and recovery Strategy for your business With a working knowledge of implementing solutions Agilent uses software from Veritas called Veritas Backup Exec M for Windows 2000 Backup Exec Agent for Oracle and Backup Exec Intelligent Disaster Recovery L LI I ding wildcards and relative as for example runs older x days For performance ins the number of clauses can be defined for automated arcuival is restricted to 10 Archive Query Path is relative to C Name testarchivet Path serverpath folder Comment Study Name is equal Method Validation Instrument Name is equal HP 1050 System 1 Schedule Frequency wake up interval is 15 min every 1 Weekl 2 v ia Automated Archive First starting date Day 22 11 2002 lol x V Active AND OR gt lt A II gt Add clause Modily clause Delete clause Time 10 00 00 togntiame Tuame Frequency ScheduegAi _3 monthly 1 daily D archivequemt Test Query __ archivequery2 _ 2003 04 01 Administrator Active 2002
345. study name database name sample name injection date and acquisition instrument Changes to method parameters can only be applied in the ChemStation For this purpose the method has stored from the database ult versions generated modified method are to the database along method Heason tor entry Successfully logged on preme off Altected user Review Client Review Client HPWBM197 HPWBM187 operator Successfully logged on Review Client HPWBM187 cnickel 6 9 00 3 47 57 PM Review Client HPWBM187 6 9 00 11 19 51 AM Logged off Successfully logged on as Manager Instrument 1 HP WBM187 cnickel cnickel 648 00 6 33 53 PM Logged off Review Client HP WBM187 cnickel 648 00 6 33 46 PM Logged off Instrument 1 HPWBM187 _cnickel 678700 1 12 21 53 PM Created batch Review Client HPWBM187 cnickel 6 8 00 12 13 01 PM Successfully logged on as Manager Instrument 1 HPWBM187 operator 5 27 00 8 48 42 PM PR off Review Client HP WBM187 operator 5 27 00 8 48 16 PM Successfully logged on Review Client HP WBM187 support 5 27 00 8 48 16 PM Logged off Review Client HPWBM187 support 5727 00 8 46 00 PM Successfully logged on Review Client HPWBM187 operator 5 27 00 8 46 00 PM Logged off Review Client HPWBM187
346. sword One user ID is valid the user access to report output for all ChemStation Plus modules only At this level data changes _so a user onlv has to remember P i are impossible 2 Data input Lc Examp leOn ly system with a1 Ss ii word of level 2 see your originals gives the user a aa PAR ETA sie tasks and valid shi ed with th e pro d U ct a loa ding stu dy d Create new user a pe ane or handed over by the ESS A of the graphics Pustomer Fnoino TI Due ee Lu 3 Planning tal Customer Engineer system With 1 ssc a ie se slip word of level 3 planning gives i e ep Compact database lt lt Create Edit advance filters Create Edit queries Create Edit report templates Operator Permissions gt Create Modify studies Create batch Chemist Permissions gt Define columns Expressions Edit Save settings Lab Manager Permissions gt Edit custom field values Administrator Permissions gt No Method Validation Permission Method Validation Permission Configuration Administration ChemStation access level iConfiauration Planning ChemStation Operator Input the user access to all level 1 and level 2 tasks plus checkpoint planning 4 Configuration level 4 configuration gives the user access to configuration rights and all level 1 3 tasks The user may change the configuration on a validation level only 5 Adminis
347. sys tems The USB GPIB cable is available as an option against the VELO CRE PoaI SIL ax E U 5 yn Please ask your local Agilent Technologies repre sentative for additional details Note USB GPIB interfaces are only supported with legacy LC and CE instruments LAN MIO Support Matrix G1369A Agilent LAN Interface Card The firmware of the card must be revision A 01 05 or higher For non LC systems 35900E ADC 6890 GC and 6850 GC a minimum Firmware Revision of C 03 00 is required Please refer to Service Note G1369 003 J2552B C JetDirect Internal Printer Servers MIO The firmware of the JetDirect card has to be revision A 083 32 or high er J4100A JetDirect N Printer Servers MI The firmware of the Je has to be revision K 0 er revision of B 01 02 A new LAN RS 232 Firmware Update Tool 2 1 is available for updat ing firmware quickly and easily Please ask your local Agilent Technologies representative for details Note Firmware Rev A 06 02 amp B 01 02 are NOT compatible with Rev A 06 02 amp B 02 01 or earlier Instruments Modules Supported on LAN Example Only see your originals shipped with the product or handed over by the Note e The 6890N requires revision N 05 04 or LAN board firmware revision 04 7B3 LAN communication with the Agilent 6890A requires firmware revision A 03 08 or higher This is available in an electronic chip format from Agilent Technologies P
348. t 1460 2571 Canted coil spring qty 1 0100 1855 Rotor seal Vespel G1946 60136 Nebulizer needle kit ES or G2427A G1946 60190 Nebulizer needle kit APCI or G2428A G1947 20029 Corona needle qty 1 The following required parts are supplied with the instrument in the shipping kit 8660 0827 Abrasive cloth 4000 grit 05980 60051 Lint free cloth 1 pk 5080 5400 Cotton swabs 1 pk G1946 80054 Cleaning wire NiCr 500 ft Issued Nov 2005 Rev 3 0 Copyright 2005 Agilent Technologies Preventive Maintenance Checklist O Discuss any problems the customer is having with the instrument Q Review customer maintenance records UO and exclude maintenance on recently serviced items Q Review the recent Autotune report 7 This will give a starting point for evaluating spectral peaks baseline noise peak shape mass assignments 0 and resolution G1956A B and G1946A B C D m Q Record instrument model no Q Q Record instrument serial no Example Only see your originals shipped with the product or handed over by the Customer Engineer O Inspect vacuum hoses pump exhaust tubing and power cords for excessive wear O Look for any obvious external damage or problems O Note any obvious external damage or problems Clean air intake on LC MSD cabinet inside access door amp above the power module Verify system line voltage meets instrument specifications O Measured voltage Drain and replace rough pump
349. t are related to a validation or the default validation template which is applied when creating new validations Both audit trails offer the following information where each item dis plays its data in a separate column e Date and time of action e Printed user name e Level of action e g level 4 for configuration changes e Status of the change saved or unsaved e Affected component e Modified checkpoint e Action the audit trail lists the menu if the user did only open the menu without changes and it lists any parameter change with the old and the new value e Display name of the signer and signature comment The program audit trail will be described in more detail in the following section Default validation audit trail The default validation audit trail refers to the general configuration of validations It covers all changes that are not related to a specific validation database but apply to the validation template that all new validatic e on upon creation Th are new validation p new validation outpt Changes to these set displayed in the defa audit trail Validation audit tr The Validation audit actions on the actual Program audit trail The program audit trail is designed to track all actions that relate to the general program operation such as save and logon actions The program audit trail table items are e Date and time e User ID e Validation name e Storage location of the ac
350. t ChemStore C S server database and are protected from unauthorized modification If the same sample injection is reanalyzed and then transferred a new version of the result data is created together with an entry in the audit trail of the Agilent ChemStore C S database thus ensuring a full history of the injection File security during data transfer Each file that is transferred over the network from the Chem Station to the ChemStore data base or back is protected with a hash value The application soft ware automatically calculates the hash value prior to any data trans fer using a 24 character value based on the RSA Data Security Inc MD 5 message digest algo rithm The hash value is stored with the data file Whenever this data file is transferred over the network e g for a reanalysis cycle the same message algo rithm calculates the hash value of the current file and compares it with the stored value Any differ ence is reported as an error and the data transfer is interrupted Assignment of studies and custom field information Runs are stored in studies which form the top level hierarchical ele ment of the Agilent ChemStore C S database similar to a drawer in a cabinet Study access is restricted to users that were explicitly granted the permission to access the data insi Fa z study Users must be a study in order to revie data or spool data into The amount of result z data that is stored in t
351. t the user s site and on the vendor s capability to offer the service with high quality Agilent 1200 Series Qualification Workbook Overview 1 The AGILENT TECHNOLOGIES 1200 Series concept Automated 00 PV of equipment hardware and complete systems OQ PV tests include rigorous performance testing of the instruments on site A report is generated with acceptance criteria actual results and pass fail comments that are acceptable to investigators auditors Automated 00 PV of AGILENT TECHNOLOGIES ChemStation The correct function of the AGILENT TECHNOLOGIES ChemStation should be checked prior to routine use after module and system updates for example after changing a processor board on the computer or after software updates The AGILENT TECHNOLOGIES ChemStation s OQ PV software checks key functions of the software such as data acquisition peak integration quantitation file storage and retrieval It checks any influence from the environment e g motors high frequency lamps on data transfer Results generated during the AGILENT TECHNOLOGIES ChemStation verification are compared to known prerecorded values The same principle may be applied to data files and methods generated by the user A report is printed that is acceptable to investigators auditors Contribution of the Qualification Workbook The chapter Operational Qualification OQ phase contains examples of documents as the OQ PV reports on the AGILENT TECHNOLOGIES 1200 modul
352. ta security mechanisms of the database itself secure the data The temporary directory where the database spooler stores inter mediate data is protected using Windows NTFS file and folder security If a first pass review in the ChemStore review client results Example Only See your originals shipped with the product or handed over by the Customer Engineer peaks in a chromatog ait WITEIT denying unauthorized access for operators Configuration and data protection using Windows security features For security reasons a user must be a member of the Windows user User task Granted to members of Windows User group group Administrators or Power Users to access the configuration of the ChemStation Plus Security Pack It restricts access to all data directories on the local PC with important information using the Windows users group privileges The default configuration automat ically sets all directory permis sions and access limitations as part of the installation using the 3 groups Users Power r Administrators Each tion user has to be mem ther one of the groups isers must not be s of the Windows trators nor Power Users The membership to these hould be dedicated for system administrators Table 10 gives an overview of the permission rights that are limited to members of the Windows Adminstrators and Power Users groups Granted to member of Power Users or Administrators group
353. tabase backup and recovery One of the most important IT routines is the implementation of a Backup and Restore concept Backups and equally as important the ability to restore a backup are important tasks in order to protect business data and labo ratory investments Agilent Technologies can provide assistance in creating implement Fa Agilent ChemSt The client server ver for manual or autom of runs present in th a separate file on dis Manual archiving Manual archiving is done from the Archive Delete view in the ChemStore C S review client and is based on the selected data set Manual archiving requires the user to have the permission for archival Individual runs or the whole set of runs are marked interactively for archival These runs are then scheduled for the next archival operation on the server Automatic archival An administrator with archival permission can set up a list of individual archive queries for automatic archiving which are executed at predefined time inter vals Each custom query is put together from a set of criteria including for example injection time sample name instrument ing and testing a ChemStore C S Server Backup and Restore strategy This strategy should ideally be planned before the implementation but Agilent offers both a service prior to the installation as well as a post implementation service For this purpose a ChemStore C S Backup amp Recovery
354. tabase so that no data is ever overwritten The versioning also assures that no data is lost and that a complete chain of events is documented This ensures full data integrity and traceability Example Only Agilent ChemSt See your originals eview and Calculation shipped with the product The graphical result example inspecting of the chromatograr in to check the integ done in the ChemStore review client If any further rework is required the data is submitted to the ChemStation batch review user interface for data reanalysis In batch review the ChemStation Plus Security Pack allows splitting the review into a working and a or handed over by the Customer Engineer ulculate the results with the settings by moving to the run or starting an automated It recalculation figure 22 As soon as new results are created the result transfer to the database is performed either for the single run or if starting an automated result recalculation for all reprocessed runs During the transfer of manually integrated data the user is prompted for a mandatory comment that is written to the results audit trail The comment can be either a selection This is done by setting new integration events and applying manual events such as baseline drawings and others without an immediate transfer to the data base The transfer is initiated automatically as soon as the user has finished his work and decides
355. taff to avoid compliance flare ups Agilent offers broad scope training courses for regulatory compliance to ensure research methods are up to date and Suitable for specific purposes In addition training will enable lab staff to create traceable chains that provide the complete records required by regulatory agencies to demonstrate proper laboratory analyses Agilent has a comprehensive training curriculum dedicated to the needs of the pharmaceutical industry These courses offer basic and advanced training in liquid chromatography techniques chemical analysis hardware and software operation as well as data analysis and reporting These courses allow the pharmaceutical laboratory to use chemical analysis instru ments at their most productive levels giving greater return on investment for all lab resources In addition courses cover methods to improve the quality of data and how to improve troubleshooting skills For convenience standardized courses are offered in select locations worldwide Or on site courses can be tailored to specific needs and time frames For the ultimate in convenience Agilent offers e seminars as a way to advance knowledge and improve lab skills on a specific subject Each seminar lasts between 60 and 90 minutes and enables researchers to gather usable information from their desktops eliminating expensive and time consuming travel Agilent e seminars keep scientists up to date on pertinent qualifica
356. th delete to recover run space in the database or dearchive operations to access run data online At installation time you can either select from the preconfigured databases con figurations listed in table 3 or have a customized configuration Database Approx Database configuration no of runs size small lt 7500 4 GByte medium lt 25000 10 GByte large gt 25000 40 GByte Table 3 Database configurations Note The custom database con figuration must be planned as a project with Agilent database con sulting specialists prior to system installation The size of the Agilent ChemStore C S database is based on an Agilent ChemStore C S system which has an average distribution of all Agilent ChemStation 2D and 3D tech niques Also all Store in Addition checkboxes are enabled for all studies as shown in figure 1 The space require ments for runs stored in the Agilent ChemStore C S e will vary depending on ronment A run is defini gle set of results produc single sample acquisitio reprocessed by an Agile ChemStation which has transferred and stored i Agilent ChemStore C S The actual amount of space con sumed by each run in an Agilent ChemStore C S database will vary depending on e the Store in Addition to Result settings of the study to which the run is assigned table 4 and e the technique and complexity numbers of peaks Agilent ChemStation reports custom fields and so on of your chro matogr
357. that include both DAD spec tral data and LC MSD spectral data in either a single or dual mode In single mode the soft ware configures the purity user interface for evaluation of data from either one of the two data types at a time The user can toggle between the data types if desired The dual mode user inter face permits simultaneous evalua tion of spectral purity using both DAD and LC MSD data In interactive operation the LC MSD peak purity function examines the most significant ions across a user selected chromato graphic peak to determine if more than one compound is present The software automatically over lays extracted ion chromatograms for the selected peak with each extracted ion chromatogram dis played in a separate color A table of the number of components located and the two most signifi cant ions used to resolve each component is displayed The next previous peak or the next previous impure peak can be Example Only see your originals shipped with the product or handed over by the Customer Engineer ible spectral data the LC MSD ChemStation also provides equiva lent capabilities for mass spectral data The MS iso abundance plot dis plays acquired mass spectra as a color contoured map of m z against retention time together with areas for display of m z sig nals and mass spectra defined by the position of cross hairs on the iso abundance plot In the iso abundance plot a color scale is us
358. the Additional GC Instrument Module G2071BA The Agilent ChemStatio combines instrument cc acquisition and data an ware for the Agilent 689 5890 Series II and 4890 chromatographs and the 35900E A D converter The Agilent ChemStatio faced to the GC via LAN and collects full range digital data from detectors Depending on the detector type data can be acquired at rates up to 20 Hz from the Agilent 5890 and Agilent 4890D Series and up to 200 Hz from the Agilent 6890 and Agilent 6850 Series When interfaced to an Agilent gas chromatograph the Agilent ChemStation can control GC parameters for heated zones oven temperatures detectors inlets cryogenic cooling signals electronic pressure and flow con trol and cool on column tempera ture programming 24 modules to allow multiple instru ment mixed technique configura tions The instrument control capabilities are documented in the In addition to GC control the fol lowing features are noted e Graphical user interface for easy access to all method areas for all Agilent GCs a MMAR duwtrrosx ert nnn nel adlana Example Only see your originals shipped with the product or handed over by the Customer Engineer Agiicitt UGIU ana Agiitiit UGUU Series only will verify and alert the operator of potential problems if a method was created on a different GC system or if the configuration has changed e Capillary columns can be calibrated from the C
359. their relatic to the voltage signal units The Agilent 35900E interfac offer external event contro through digital TTL transis transistor logic signals ea which are given specific st high and low names that time programmed before d and after an analysis The 4 35900E can be configured for up to eight signals for each indepen dent channel Fraction Collectors All different versions of the Agilent 1200 1100 Series fraction collectors G1364A G1364B G1364C G1364D can be fully con trolled from Agilent ChemStation Fraction data can be reviewed in the fraction task of the data analy sis screen The maximum number of fraction collectors connected to one Agilent 1100 Series Purifi cation system is limited to 3 with the possibility for one additional recovery fraction collector Depending on the system configu ration up to two Purification sys tems can be controlled from single ChemStation system without purification related software add on Optional add on software e g High Throughput Purification soft ware G2262AA G2263AA G2265AA or Easy Access G2725AA provides advanced functionalities Agilent 1200 1100 Series Instrument Verification Example Only See vour originals shipped with the product or handed over by the Customer Engineer To perform instrument verification it is first necessary to purchase the relevant service from Agilent Technologies The required method
360. this case no calculations are performed and the chromatogram is attached to the validation as a bitmap BMP format or windows meta file WMF format and included in the overall report Figure 43 shows o Ing dialog of the check rit of detection quantifi data unation method lt value method rding ICH ration line method rding to ICH method Data type Height bd Additional header info Header line 1 Header line 2 Header line 3 Header line 4 I Header line 5 Calibration Function The calibration function is the correlation between the expected value ofthe test characteristic e g the extinction see DIN 55350 part 13 and the content e g a mass concentration Calibration Calibration is the process of analysis of calibrator solutions which are solid or gaseous standards of known content It serves to define the calibration function The dependence of the signal y on the unknown variable x can be described by the general curve equation y a bx for the linear case This curve equation contains two narameters first the method hlank value a determined xl Planning dialog of checkpoint Calibration Function 55 e Signal noise ratio according to ICH e Other data e Nominal values for the detection limit d and quantitation limit q e Number of samples e Y units e Multiple injections possible Output settings for calculations e Standard devi
361. timetable to change Polarity and Peakwidth of the acquired chromatographic signal For diagnostic and troubles hooting purposes it is possible to store Diode Signal 1 Diode Signal 2 Optical Unit Temperature Relesit and the Balance Signal in to the chromatographic ent 1100 Series fluores tector FLD may be pro 1 for single wavelength or eous multiple wavelength 1 and spectra aquisition ur signals at different exi different emission wave rengas may be obained Within a timetable initial exitation or emis sion wavelengths response time PMT Gain and baseline behaviour as well as spectral parameters may be changed Exitation or emission spectra can be watched online and stored and analyzed as described for DAD spectra For a single compound trapped in the flow cell complete information on exitation and emission spectra is available in a single task with the fluorescence scan and can be watched as an iso plot or as 3D graphics The Agilent 35900E dual channel interface allow the system to acquire data from detectors that are not interfaced for data acquisi tion through GP IB or LAN such as the FPD the HP 1047A refrac tive index detector or a third party detector One or two analog sig nals per instrument may be config ured if only one is used the other is available for use with another instrument Data rates up to 100 Hz per signal may be defined The user may also define the units for acquisition and
362. tion Comment Figure 41 Planning dialog of checkpoint Linearity The result includes all indices along with the specification limits and a judgement if lab capability is low medium or high 54 Calibration function The calibration function is the correlation between the expected value of the test characteristic e g the UV absorbance see DIN 55350 part 13 and the content e g a concentration The user can specify the maximum degree of curve fit for the calibration curve lst order is standard and 3rd order is the maximum cubic curve Figure 42 shows the planning dialog of the checkpoint calibration function _ Planning data f e Number of levels Unit of values Curve fit display 1 3 Multiple injections pos Multiple determination possible Output settings for calcu e Vector y ax b curve in the case of linearity e Square sum of the residuals only calibration function e Residual standard deviation e Mean value and standard deviation of y e Multiple correlation coefficient e Results of F and t tests e Method standard deviation Limit of detection and limit of quantitation The detection limit LOD is the smallest amount of substance that can be detected qualitatively during one analysis with a defined statistical certainty The quantitation limit LOQ is the smallest amount of a substance that can be detected quantitatively during one analysis with a statistical certainty
363. tion techniques and procedures troubleshooting and system optimization techniques Featuring a user friendly internet conferencing system that allows you to interact with the speaker e seminars enable the attendee to participate from the office home or out of town using a basic internet connection and a browser such as Microsoft Internet Explorer or Netscape Navigator You can find a complete listing of compliance related e seminars at www agilent com chem eseminars Multi Vendor Validation Program offers a single solution Compliance offers enough challenges on its own then consider that many labs uti lize many different brands of instruments The task can be daunting Agilent offers a solution based on a single set of protocols applicable across a variety of instruments regardless of manufacturer Laboratories that are seeking methods to streamline experiments and increase productivity can rely on the M ulti Vendor Validation Program It allows a lab manager to make one call schedule one vendor and keep disruption to an absolute minimum This program can be applied to many instruments including the follow ing UV Spectrophotometer Liquid Chromatograph LC e LC MS Gas Chromatograph GC GC MS Dissolution Tester Capillary Electrophoresis N ot available in all areas e PIF It is our goal to allow Agilent customers to comply at the lowest cost and with the highest confidence
364. tivities including Sale of equipment Compliance Services Installation Repair and Onsite maintenance of analytical test equipment in Chromatography Spectrometry Laboratory Automation and Laboratory Information Technology equipment project consultancy and user Training in Australia Centralized Support from the following Analytical Response Center Europe Amstelveen United States Little Falls DE Central Call management Customer Engineer E and the provision of Software Support internal and to customers Field Supp GE tC located in Ger FSC Waldbronn and the United States AFSC Little Fe D lagement CE Assist for Hardware products escalation m er training Field Repair Cent laldbronn and the United States ERC Little Falls Repair Services and Instrument Exchange pr Business Ce 2d States Little Falls DE Order fulfilln rd and supplied ses concerning analytical test equipme ography Spectrome ation and Laboratory Information technology equipment H Pierre Sall President KEMA Registered Quality The method of operation for quality certification is defined in the KEMA General Terms And Conditions For Quality And Environmental Management Systems Certifications Integral publication of this certificate is allowed KEMA Registered Quality Inc Accredited By 4377 County Line Road ANAB Chalfont PA 18914 Ph 215 997 4519 Fax 215 997 3809 CRT 001 073004 ANAB ACOREDIT
365. tration Logging into CA 55 8 l Approve I Reject Batch Apply Canca Hep Sample 1 9 Next Exclude Include the system with a name and a Status 3 13 02 10 24 AM N Start GP ChemStore C S chr nick lt BY 10 24 AM password of administrator level 5 gives the user access Figure 48 to all functions of Method Central user administration for ChemStation Plus including Method Validation Pack user administration and user levels Validation Pack including the program configuration global settings such as the default validation settings for new vali dations 61 Agilent ChemStation Plus Method Validation Pack Data Security User authorization As mentioned under User management only users with a valid ChemStation Plus user ID and password can log on to the Method Validation Pack software The user management includes a password policy for regular pass word renewal and user account e MVS section for method validation sequences all ChemStation method validation sequences that have been created from the validation database e DOC section for reports all reports are stored as doc files that have been printed for the validation database e PDF section for reports in pdf e name e label lockout after a specified pumhar af unsuccessful password details please refer to C Example Only for review All DMS entries are displayed
366. ts in one sequence This will be the most suitable and efficient way in case the method will not be transferred between instruments and thus no ruggedness testing is required or if no time consuming tests are involved such as long term stability If a validation is structured per component in a way that each 50 component can be validated in a separate sequence either on the same or a different instrument sequences can be submitted per component Method Validation Pack then creates a sequence for every component Depending on the number of compounds and the extent of validation it might be useful to define your own set of validation sequences For this purpose the custom sequence submission Example Only See your originals shipped with the product or handed over by the Customer Engineer submit the sequence 10 make It transparent to the user which checkpoints were already submitted these are immediately highlighted in green The number of necessary experiments can be further reduced by the ability to share data between checkpoints for example by using the same data set for more that one test like for example reusing linearity data for the calibration function check point Data sharing is defined during sequence submission where the software automatically offers all available choices that would allow data sharing due to the same data structure Level 2 Data input After checkpoint configuration and planni
367. tual validation snapshot copy e Action Program start and stop user logon and logoff IQ execution validation opening use of import mask for data entry and program options Example Only See your originals shipped with the product or handed over by the Customer Engineer DMS system Only users with an access level 3 planning or higher have access to the locking functionality Each locking action requires an electronic signature The electronic signature uses the password user ID combination as defined by the FDA figure 54 The sign off dialog comes with a time limit of 45 seconds If the signature was not executed during this neriod the dialog will close he validation status remains anged item was locked by mistake is to be modified due to late ges in the test specifications ack status can be removed by Tr with sufficient privileges 13 or higher For unlocking idation component or kpoint the same procedure is wed as for locking The user has to give an electronic signature to initiate unlocking Validation locking and electronic signatures After completion of a single check point an entire component or a complete validation a validation can be locked to the same extent to prevent further modification To avoid locking of incomplete items the application software will display a warning message and close the lock dialog without the graphics Every locking action automatically creates a new revis
368. ty Pack client in ChemStation Plus Security Pack C S installations Includes manual 1 license for either online or offline use and media Supports 21 CFR Part 11 Must be on the same order as G2183AA or requires a valid license for G2183AA ChemStation Plus client upgrade software Upgrades a single ChemStation Plus client to the latest software revision Requires valid software licenses and ChemStation upgrade software G1656A ChemStation Plus server upgrade software upgrades ChemStation Plus server software to the latest revision Product No G2183AA 1 per PC 1 per laboratory G2187AA 1 per PC be in the same laboratory G1657A Product No G1410A Oty 1 per server G1411A Oty number of clients connected to server 5 G2183AA Oty 1 per server G2186BA Qty number of clients connected to server 1 G2187AA 1 per PC in the same laboratory G1657A G1655BA Includes G1656A ChemStation software upgrade Requires valid software license 4 Agilent ChemStation Plus Method Validation Pack Introduction A comprehensive understanding of the functionality of Agilent ChemStation Plus Method Validation Pack requires a brief introduction to the general aspects of method validation The goal of method validation is to provide documented evidence that a specific process will consis tently provide results meeting the predetermined specifications This definition is taken from one of the FDA s
369. ude typically lt 1 at all pressures gt 1 MPa Low delay volume configuration lt 5 amplitude typically lt 2 Compressibility Automatic pre defined based on compensation mobile phase compressibility Recommended pH 1 0 12 5 Solvents with pH lt 2 3 should range not contain acids which attack stainless steel Gradient formation High pressure binary mixing Agilent 1200 Series Qualification Workbook 2 Design Qualification DQ Phase Table 7 Performance Specifications of the Agilent 1200 Series Binary Pump SL continued Type Specification Comments Delay volume Standard delay volume configuration measured with water 600 800 ul dependent on back pressure includes 400 pl mixer Low delay volume configuration 120 ul Composition range settable range 0 100 recommended range 1 99 or 5 ul min per channel whatever is greater Composition precision lt 0 15 RSD at ImL min Composition accuracy 0 35 absolute water caffeine tracer Control Agilent ChemStation for LC 32 bit Revision B 02 00 or above G4208A Handheld Controller EZ Chrom Elite Analog output For pressure monitoring 1 33 mV bar one output Communications Controller area network CAN RS 232C APG Remote ready start stop and shut down signals LAN optional Safety and maintenance Extensive diagnostics error detection and display through Agilent LC Diagnostics leak detection safe leak handling leak output sig
370. ure 47 Additional Method Validation menu item in the Data Acquisition ChemStation software module 59 Agilent ChemStation Plus Method Validation Pack Interaction with other ChemStation Plus modules Data management ChemStore manages the analytical results along with the raw and meta data of the samples in a relational database This also includes all analytical data of the method validation sequences that have been acquired in the ChemStation The method validation_data_are stored in method vi studies Method va are similar to stan studies except that created and modifi Method Validation All method validat are visible in Chen can not be change except for reanaly the data transfer fim Validation Pack to ChemStation the Method Validation Pack software creates and when revising data updates a method validation study in ChemStore The study name corresponds to the validation name It is recommended to use short validation names as a study name is limited to 12 characters Method Validation studies have three custom fields automatically configured with the studies These fields are e MV_checkpoint storing the Method Validation Pack check point information which test was used with this run e MV_component the name of the Method Validation Pack component in the validation comparable to the ChemStation Plus compound 60 e MV_runID storing a unique run identifier that allows full tra
371. ure changes of 2 C hour or less as defined by ASTM conditions are required to achieve best possible baseline stability Higher variations will definitely result in higher signal drift and wander of the baseline ee Agilent Technologies G1321A lt 95 non condensing Module G1365B C G1362A 0 to 40 C 32 to 104 F constant temperature All other modules Example Only PI DANENS O8 See your originals O PLEASE NOTE shipped with the product Au Agilent 1200 parer or handed over by the Les cane with line voltages in the range of 100 240 VAC 10 Customer Engineer ywer BTU Consumption VA Consumption W G1310 11A Iso Quat Pumps 180 VA G2226A Nano Pump Performance Autosamplers G1312A Binary Pump 220 VA Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 3 of 8 Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation Specification us Agilent Technologies W Other considerations O Module Stacking Bench Space The modular dimensions and weight allow the instrument to be placed on almost any laboratory bench The instrument requires a space of at least 2 5 cm 1 0 inch on both sides and approximately 8 cm 3 1 inches at the rear for the circulation of air and room for electrical connections If the bench is to support a c it the bench is designed to carry the total weight of all the module Exa mp 6 0 n
372. ured voltage Parts required i ae 6040 0834 Rough pump fluid 1L Q Drain and replace rough pump fluid 6040 0834 Preventive Maintenance Checklist Q Tighten the four bolts on the rough Q Customer Signature Q Discuss any problems the customer is pump that hold the oil box to the having with the instrument pump body This will help eliminate rough pump oil leaks Q Review customer maintenance records Q Support Provider Signature and exclude maintenance on recently O Pump the system down serviced items Q Review the recent Autotune report Q Record current vacuum readings This will give a starting point for O Rough Vacuum evaluating spectral peaks baseline High Vacuum noise peak shape mass assignments and resolution UO Verify that all temperatures pressures and gas flows reach tune file set points Issued Nov 2005 Rev 3 0 Copyright 2005 Agilent Technologies LC MS Technical Marketing Page of 1 Performance Qualification PQ Phase 5 System performance and noise Agilent 1200 Series Qualification Workbook Data File C CHEM32 1 DATA DEMO ISOCRA D Sample Name Isocratic standard sample Acq Operator marketing Acq Instrument Instrument 1 Location Vial i Injection Date 24 Feb 06 5 02 20 PM In vV lume i pi Method C CHEM32 1 METHODS ISOCRA M Last changed 24 Feb 06 4 58 15 PM by marketing Method Info This method is used to analyse the isocratic standard sample with standard
373. use before a password can be re used The default is 12 which means that a user must change the password at least 12 times before re using the original password The range is between 0 and 32000 e Account lockout after x attempts where x is the number of failed log on attempts gt maximum number of acutive unsuccessful ypts that a user can enter e ChemStore rejects the The default is three with id range between 0 and If the maximum number entries is reached the nt user is invalidated and be reactivated by a user the required permission Password settings Minimum password length Eo characters Password expires in a0 daps Password uniqueness Remember 12 passwords Account lock out after fa attempts omon Hoe Figure 25 Password policy ChemStation Plus Security Pack Audit trails and change documentation The Agilent ChemStation Plus Security Pack includes four audit trails e run logbooks e method revision history data e sample audit trail and e database logbook Run and sequence logbook During data acquisition all events are documented in the sequence and run logbooks with date and time stamp figure 26 The sequence and run logbook documents all data acquisition events such as e start and execution of methods e the actual sequej e all run versions All reanalysis events and result e all user comments during versions are documented in the reanalysis cyc
374. users data review process offering statistically result summaries flexible control charts cross sample reports and documented data archiving and restoring These services also aid users in doing on going system suitability testing The Agilent ChemStore C S server database can be used as a Single place for data storage for all analytical data including methods sequences and the raw data This data storage also satisfies the requirements for data handling in a regulated environment including the detailed requirements of the U S food and drug administration for electronic records and electronic signatures known as 21 CFR Part 11 Agilent ChemStore C S is available in two different configurations e Agilent ChemStore C S standalone database This provides a low cost easy to use entry level database module which integrates with a single Agilent ChemStation workstation Very limited main tenance support is required and s r with advanced know f the Windows XP or 7s 2000 operation system ality for backup and stration can maintain it ry level database module for storage of all raw ta data in single data e to ensure full data y The file format adheres Jnmon standard which is used by many other applica tions for example MS Access e Agilent ChemStore C S server Oracle database client server system This client server system is based on an Oracle database running on a Windows 2000 server together with multiple
375. valves Leak detection and safe leak handling error detection and display exhaust fan for fume extraction of hazardous vapors Agilent 1200 Series Qualification Workbook Design Qualification DQ Phase 2 Fraction Collectors Specifications Vials and well plates and capped vials and well plates with closing mats can be used as recom mended by Agilent Technologies see List of Recommended Vials and Caps in the manual and List of Recommended Plates and Closing Mats in the manual NOTE Only one type of well plates can be used ata time in one tray Agilent 1200 Series Qualification Workbook Design Qualification DO Phase G1364D Micro Collector Spotter Performance Specifications Table 34 Performance Specifications Agilent 1200 Series Micro Autosampler G1364D Type Specification trigger modes operating modes fraction vessel capacities and trays MALDI Spotting plates pre configured MALDI Plate Capacity Minimum fraction volume MALDI spot size maximum spotting rate Maximum flow rate Time slices Peak threshold up downslope Timetable combination of time intervals and peak and Agilent 1200 UV Vis detectors DAD G1315A B MWD G1365 A B are fully supported Other detectors with appropriate delay volumes can be connected through UIB interface Above location Into location Liquid Contact Control The tip of the fraction collector capillary will initially move down to the bottom of th
376. ver a corruption of the datafile is detected the user receives an error message and the file is no longer available for modifications Approve or reject runs after reviewing following the rules for electronic signature Ability to flag an arbitary set of samples for reprocessing and to initiate batch reprocess ing of those samples on any Agilent ChemStation in a C S network Custom fields User specified Example Only see your originals shipped with the product or handed over by the Customer Engineer and reports User controlled fast and easy data export to other applica tions such as MS Excel Powerful and intuitive report generator based on MS Access runtime including most commonly used report tem plates Architecture allows for off line review Can be installed as a data review client running on a separate PC without needing the Agilent ChemStation soft ware e Data from non Agilent chroma tography systems may be included via the Agilent Chem Station AIA import capability Agilent ChemStore C S offers the possibility to start with an entry level solution and to then upgrade when the data process ing needs increase Laboratories can easily upgrade from one or more entry level standalone systems to an Agilent ChemStore C S server Oracle database client server gt m Previously stored data entry level databases can sily migrated to the new r database The user inter does not change e
377. voltage drying gas temper ature and EMV gain can be acquired and saved with a data file These instrument parameters can be displayed and plotted as a record of the exact values associ ated with the acquired data In addition to the standard ChemStation automation capabili ties for single run methods and mutiple method sequences an FIA Flow Injection Analysis Series automation mode is available through software selection In this mode which requires the Agilent 1200 1100 Series LC autosampler the Agilent 1200 1100 Series LC MSD system can be pro grammed to make multiple injec tions from a single or multiple sample vials storing all data in a single datafile Up to two LC MSD method parameters can be pro grammatically varied with each Injection The system includes the ability to do fast scanning of up to 5250 amu sec and includes autotune for fast scanning Also included is of the Agilent Analog ccessory which provides SIM signals directly to a Tr LIMS system Tuning ent ChemStation for systems includes a _ tune view in which users gilent 1200 1100 Series LC MSD may select to either auto matically or manually tune the instrument The Agilent 1200 1100 Series LC MSD integrated cali brant delivery system is software controlled and together with the software autotune provides fully automated tuning of the Agilent 1200 1100 Series LC MSD for API electrospray API ES atmospher ic
378. wing consumables For G1367B these parts are all included in the G1367 68730 Wellplate Autosampler PM kit 1x Rotor seal 0100 1853 Vespel 1x Needle seat G1367 87101 1x Needle G1367 87201 1x Peristaltic pump cartridge 5065 4445 1x nut for sample loop fitting 0100 2086 For G1377A 1x Rotor seal 0100 2088 Vespel Ix Needle seat a 1x Needle 1x Peristaltic pun Exam ple Only See your originals For G2258A A 1x Rotor seal shipped with the product 1x Peristaltic pun i Note If the follo or handed HYEN by the needle is deformed or if needle seat are I Customer Engineer UST be BILLED SEPARATELY _ 1x Needle seat G2258 87102 1x Needle G2258 87306 1x Fitting kit 2mm 5065 9950 Note After a needle has been replaced several times the buffer loop capillary will become too short and will also have to be replaced 1x buffer loop capillary G2258 87300 G1328B Manual Injection Valve and 5065 9922 Prep Manual Injection Valve This maintenance procedure requires the following consumables 1x Rotor seal 0101 0623 Vespel for analytical scale manual injection valve G1328A B or 1x Rotor seal 0101 1233 PEEK for preparative scale manual injection valve 5065 9922 Issued Feb 2006 Rev 1 0 Copyright 2006 Agilent Technologies WAD Product Support Page 10 of 11 Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist G1316A Column Compartment This maintenance procedure requires the f
379. xample Only see your originals shipped with the product or handed over by the Customer Engineer Customer Responsibilitie The customer should ensuri necessary operating supplie consumables and usage def items such as vials syringe solvents are available Users instrument should be present at all OQ GIBI6A Column times during the familiarization Compartment otherwise important information on x m l o da 58A 59A 60A 62A 63 Valves operation and maintenance may be missed The manuals delivered with the instrument will be used as a guide during familiarization and should be available a G1314B C VWD a G1315B C DAD G1365B C MWD a G1321A FLD a G1362A RID QO G1364B C D Fraction Collectors a G1330B Thermostat for Samplers or Fraction Collectors Note Typical familiarization times for a Bundled LC System are 2D System approx 6 5 Hours 3D System approx 8 5 Hours O Below Item Not Applicable see note If customer did not purchase familiarization time for the 1200 a check that section as not applicable Demonstrate stand alone operation for each installed Module using the Control Module Use the Control Issued Feb 2006 Rev 4 0 Copyright 1995 Agilent Technologies WAD Product Support yee Agilent Technologies e Module Screens for the 1200 section from the appropriate Module Reference Manual as guidance Review the following Screens 1 Views
380. xcept some additional items are able for administrators It in archive delete tool s for easy data transfer to disks and or media to free tabase space while keep ing a complete audit trail of all archiving and delete operations Automatic archiving based on a set of configurable archive queries for easy data base maintenance and adminis tration Open system connectivity using XML Extensible Markup Language for easy data exchange with other applica tions Advanced email notification feature C S only See page 37 for details Agilent ChemStore C S System Requirements 1 Agilent ChemStore C S standalone Hardware requirements The following list shows the mini mum hardware requirements for this application e 600 MHz Pentium III Pentium IV recommend e 4 GByte of free hard disk space e 128 MB RAM for single Chem Station instrument 256 MB is recommended for best perfor mance for Window minimum requiremi e 256 MB RAM for tv Station instrument more is recommen performance e Display 1024 co 76 fonts 65 th ors Software requirem The following list shows the minimum software requirements for this application e Windows 2000 Professional with Service Pack 4 or Windows XP Professional Number of peaks 4 short 4 short 4 extended performance 20 short 20 extended performance Table 1 Agilent ChemStation report style Run length Service Pack la e Agilent ChemStatio
381. y all users are required to log on to a single database This database determi nation of the database connection requires the log on to the Windows operating system with a Windows administrator account will store all raw meta and result data In addition any recalculation of results in the ChemStation will automatically be recognized as a new result version and will be transferred to the database as a new version This versioning assures that no data is ever lost or overwritten and that a complete chain of events is documented If a new result version is generated the user is forced to latory comment tten to the audit trail lata traceability the 1 Plus Security Pack ooks and audit trails nt who did what when ese logbooks and audit er independent and odified or deleted All data is in electronic format and capable of long term storage through archive restore as well as viewing and printing in human readable format Key product features of the ChemStation Plus Security Pack include storage of all chromato graphic data in a relational data base secured through e password protection to access the data e full data protection using Windows security and data base security features e application protection with a mandatory log in consisting of both identification components user id and password e user management with individual user profiles and privileges for the application independent
382. y auto and integrated with the ChemStation Plus modules ca transfers are automatic Jcumented in audit trails thus ng any accidental transfer or ription error Run sequence to acquire data Integrated sequence Validation Pack Create Dynamic validation report from database and update generation study creation ChemStation Compliant storage of raw and meta data ChemStore Database Figure 34 Interaction of ChemStation Plus software modules and their mapping of the key steps of method validation experiments User levels Top level Level 4 and 5 Validation setup and configu ration Setup Method Validation Pack organizes data in method validation databases A method validation database is the top level container for all data that relate to one validation All settings are linked to one validation data base For new validations the soft ware offers a master validation template that allov validations based The following settii are configured per figure 35 and can in a template e validation confi e output settings e default reportin e storage of exter and LI e storage of method in text format Validation configuration The validation configuration defines the parameters for the statistical calculations in the report Each checkpoint offers different calculation options and is config ured individually For example the user may decide which level
383. y the Customer Engineer 0 3 e Retention time locking software add on module for Agilent ChemStation for gas chromatography e Agilent ChemStation for liquid chromatography revision A 08 04 to A 10 0x e Gel permeation chromatography software add on module for the Agilent ChemStation for LC e Agilent ChemStation for capillary electrophoresis revision A 08 04 or later e Agilent ChemStation for liquid chromatography mass selective detection revision A 08 04 to A 10 0x e Agilent ChemStation for analog signal acquisition revision A 08 04 to A 10 0x and e Agilent ChemStation for capillary electrophoresis mass selective detection revision A 08 04 or later Agilent ChemStation that is rated in an Agilent Chem ss C S system should con to the following Agilent Station and Windows soft ee revisions e ChemStation for GC LC LC MSD CE and A D revision A 08 04 to A 10 0x on Windows NT 4 0 Service Pack 6a or Windows 2000 Service Pack 2 4 e GC MSD ChemStation revision C 00 xx on Windows NT 4 0 Service Pack 6a e GC MSD ChemStation revision D 00 xx on Windows NT 4 0 Service Pack 6a or Windows 2000 Service Pack 2 Note Agilent ChemAccess C S currently does not support the Agilent ChemStation for UV visible systems Server hardware requirements Agilent ChemAccess C S supports up to 15 concurrent Agilent ChemAccess clients where con current is defined as a client con nected to th

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