The instrument control including various
Contents
1. E X mi Page 1 of 1 49 6182 9532 600 49 6182 9532 650 email pharma test de PHAR www pharma test com Page 8 of 16 lle Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 Dynamic Report Editor The WinDiss32 report organizer allows users to produce customized reports with the right information by selecting from a combination of objects such as Method Header Data Tables Method Parameters Graphs and the Company Logo These details may include any parameter measured during the test such as bath Temperature Paddle speed Time Intervals as well as Absorbance Concentration and Dissolved Any number of pages can be selected with automatic page numbering Standard Report Format Graphics Printer WinDiss32 is supplied with a Graphics Printer that provides compliance with 21 CFR Part 11 requirements for human readable form These reports can be circulated emailed etc in the safe knowledge that they are non editable Print Driver Control Dialog a Ez Output File Name JLIssG RAFPHI 15Faracetamol TIF Format TIF Browse File Format TIFF 24 bit color PackBits Page Format Multiple Pages Petr File Mw View When Done Advanced cancel _ This Graphics Printer can capture any report into TIF BMP or JPG JPEG and save them as electronic files The TIF format can save a multiple page report and the Image Viewer supplied automatically dis2. Dissolution Rates Below are some interesting statistics covering various things which may influence the results of a typical dissolution test run Some influences are quite small but others such as degassing the dissolution medium are quite dramatic ask for the PT DDS Medium Degassing and Preparation Instrument brochure Factors affecting the PQ results Type Rating influence degree Temperature not too significant linear Speed significant 10 30 Vibration significant 10 40 Centricity reasonable 5 15 Dissolved Gas significant 50 Media pH reasonable 5 10 Media Contamination significant 20 45 Sampling Position not too significant 5 10 We reserve the right to make technical changes without any prior notice
3. irom Stirrer Design Mono Shaft stirrers and stirring tool adapters When immersion depths is set once no need to repeat when stirrer adapter has to be changed Vessels Individually batch coded 1 litre USP EP graduated glass vessels Vessel Centring Auto Centring System for each vessel Thermostat Built in circulating pump spring loaded for vibration free operation and 1000 W heater Temperature Adjustable within 25 45 0 C accuracy 0 3 C Wake Up Programmable wake up time including heater start Vibration Absorber The water bath is placed onto 4 Vibroban vibration absorbers measurable vibration at the vessels lt 0 25 um displacement Water Bath U shaped Plexiglas water bath with PP cover and drain cock built in water diffuser for faster heating up times Standard Supply includes 8 stainless steel mono shaft stirrers 8 stainless steel Paddle blades 8 USP glass vessels depth and centring gauge Sampling System EPE auto sampling system including 10 micron PP sinter filter attached to each sampling ferrule Ham TEST ee Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 Tubing Installation Tablet Magazine Cleaning Assistant Documentation CAT 8 Piston Pump Peristaltic Pump IPC 8 channel Pump Tubing Pump Speed Accuracy Pump Channels Interface Documentation CAT 8 Piston Pump Number of channels Pump head type Material Stroke volume of pump head Minim
4. 8 can be filled with a fresh Reference Standard Cuvette 7 is connected to vessel 7 which may hold Blank Media One or both can be measured each time prior to the measurement sequence This has an advantage in that minor variations in absorbance values encountered over a series of measurements can be compensated for as each set of measurements is made relative to a Reference Standard which has been treated in exactly the same way as the samples At the end of the pre programmed sequence the dissolution time profile as well as the final concentration of active in solution may be displayed or printed prior to storage Operating Principle Dissol Bath s ristta li Fhotometer cell changer i Bland and Reference Media Wessls lees phann Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 On line Systems Using an automated Dissolution System is offering a good number of advantages such user free sampling on line measurement of drug absorbance accurate sampling timing precise sampling positioning both either using an inside media sampling probe insitu or a removing EPE sampling system which remains only inside the media as long as sampling takes place Also data correction using the on line Standard and or Blank Media and automated result calculation will save time and offer highest quality data presentation This popular configuration is elaborate but allows real time calculation of results us
5. ID BB6F5ACF C19C 4BFS A56E GD45CA7B167E a Run completed for Data ID BB6F5ACF C19C 4BF9 A56E 6D45CA7B167E Method Re saved Changing its ID to 137A1C05 65CB 4ADF 8E77 287F 13765EAF from w 4 Print Report Cancel Networking Our networked system provides a central relational database that contains all data methods and data records from all WinDiss32 workstations Details are accessible from any station linked to the networked database Each system runs from a workstation PC as each hardware configuration can be unique This configuration allows Data records to be signed remotely by users from clients For example it is now possible for analysts and supervisors or managers to view sign print etc away from the laboratory area M EB PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER 49 6182 9532 600 N 49 6182 9532 650 email pharma test de PHAR x www pharma test com ID X 38 04450_ADS310_09 10E Page 10 of 16 eee Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 m E n E IDIS EE fClient HPL System 1 IDIS EE Database on Wetwork Server IDIS EE HPLC VYorkstation 2 FLE Workstation 1 E A HPL Haket 2 HPLO System 3 Uy Spectrophotameter 2 Keeping the cost sensible We at Pharma Test have opted to take the work out Spectrophotometer selection and accessory hunting by offering c
6. Light Source Lifetime Wavelength Range Maximum measurement speed Number of Diodes Optical Grating Spectral Resolution Spectral Bandwidth Wavelength Accuracy Wavelength Precision Noise at 580nm Baseline Drift Temperature Drift Scattered light Data Integration Flow cell compensation PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER 38 04450_ADS310_09 10E D and Tungsten lamps D lamp has a life of approx 1500 hours 190 1020 nm 12 milliseconds Spectrum 1024 248L mm 0 8 nm Pixel 1 6 nm 0 3 nm 0 07nm 2 5 x 10 AU 5 x 10 AU lt 0 005nm C lt 0 1 340nm D2 lamp Data integration time approximately 100ms per channel Work with either absolute or baseline corrected absorption data ogm p 49 6182 9532 600 49 6182 9532 650 email pharma test de PHAR x www pharma test com Page 14 of 16 LLL Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 Communication Port Ethernet and RS232 Multiple Cell Changer 8 cells max path length 20 mm or 16 cells Flow Through Cells 0 1 0 2 0 5 1 0 2 0 5 0 10 0 20 0 mm path length not included in the supply scope Setup Electronic system The SA 500 uses a very fast RISC Processor and processes the raw spectral data within the unit All data storage and post processing is then via an external PC Documentation Includes User Manual IQ and OQ Documentation WinDi
7. d with a built in 8 cell changer as standard It can therefore be used for both manual operation as well as for fully automated Dissolution Testing applications Features Excellent reproducibility and drift stability Integrated 8 way UV cell changer for 10x10 mm flow cells high performance characteristics flexibility user friendly operation VVVVV Reproducible measuremenis UV Visible Spectroscopy is a universally accepted well documented technology with many applications The technique is extensively used for the analysis of foods drugs agricultural pHaam TEST Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 products and is widely used in the medical care public health environmental protection life sciences industries and many other organic and biochemical applications The T70 series of UV Visible Spectrophotometer offer excellent performance high quality and are competitively priced The T70 range of UV Visible Spectrophotometers are well able to meet the stringent requirements required by analytical chemists WinDiss32 Software The CFR 21 Part 11 compliant WinDiss32 software drives the system and collects the results In includes system operation log file audit trail user access right administration password protection and administration electronic signature report generator etc It offers single or multi component analysis The ADS System components are controlled and in
8. ee Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 PHaamga nae The ADS PTWS310 Fully Automated Tablet Dissolution Test System includes a PTWS 310 4 4 vessel Dissolution Bath which is equipped with the EPE Auto Sampling System and the ITM Media Temperature Monitoring Device For sampling the ADS PTWS310 is equipped with Teflon Tubing for each vessel to avoid any cross contamination all tubes are connected with a IPC 8 Peristaltic Pump including ISMAPRENE pump tubing The instrument control including various Spectrophotometer Drivers is done by the WinDiss32 Software Platform which offers full 21 CFR Part 11 compliance and all data handling The PTWS 310 4 4 station Dissolution Bath is equipped with the EPE Auto Sampling Manifold and a manual Tablet Drop Magazine The added advantage of the EPE option is that the sampling probes are only in the dissolution medium when sampling is required The EPE is raised out of the vessels after the sampling sequence is complete This fulfils the other school of thought that sampling probes should only be in the solution for a minimum period so as to avoid unnecessary solution perturbation Each sampling tube may be fitted with 5 or 10 micron in line filters so as to avoid the passage of insoluble excipients into the measurement cells inside the spectrophotometer Using the Tablet Drop Magazine all 6 8 samples are dropped at the same time into the Dissolution Vessels for simultaneous sam
9. igured for each user with Group or individual access rights Individual access to the system is by a unique user name and password and the users full name is displayed whenever the user logs on successfully ae Administration a e Groups m Administration Group H Analytical Development Sa Quality Control Hab Password Settings H 2 Group Access Rights Sas Users agti Denise fe ti John E A Keith 3 aah K Townsend Hd Password LIE Use Group Access Rights Hl Log on Levels Query Data Print Data Query Delete Data Fost Edit Calculations 1 Fost Edit Calculations 2 and Group Settings Fost Edit Run Options Fost Edit Sample Details Fost Edit Standard Details Fost Edit Batch ID and UDFs Fost Edit Flow Rates Fost Edit Sample Weights save Post Edit Data oll Oe Export Method and Data el eport H Group mj Inactive Groups Inactive Users Configurable Centralised Security The Global Settings allow the administrator to set limits to prevent unauthorised access to the data station Password Expiry Log Off Times etc for each access level These activities can be performed remotely from any WinDiss32 networked workstation PHARMA TEST AG fy 49 6182 9532 600 N Siemensstrasse 5 B 49 6182 9532 650 D 63512 Hainburg GER D lt email pharma test de PHAR m www pharma test com io 38 04450_ADS310_09 10E Page 6 of 16 Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 WinDiss32 pr
10. ing the new fully 21 CFR Part 11 compliant WinDiss32 software and is by definition PC controlled The overall structure of both software packages and their programming options is described in our WEB publication called Dissolution Automation Key points for Consideration With this multi cell changer configuration the basic automation elements are entered into the program structure This data once installed will cause the software to further interrogate the user as to the configuration of the automation elements Taking the spectrophotometer as an example the program needs information as to whether there is a cuvette changer or not and if so then is it a 6 8 way or even 16 way This is vital information as the Blank Medium has to be compared to the reference cell and zeroed at the appropriate wavelength This is done on cell 7 14 to 16 with an 8 or 16 cell changer as this positions are usually connected to the Blank Media Vessel The Standard Media for concentration calculation is usually in cell 8 or 15 to 16 This means that the medium can be compared to the reference cell and zeroed at the start of each measurement sequence After the zero has been established the measurement sequence is then cell 8 Reference followed by cells 1 to 7 or to 16 What is an ADS PTWS310 system The ADS PTWS310 system offers an auto dissolution package incorporating validated systems and software including all necessary drivers for the dissolution bath the p
11. omplete upgrade systems for existing Dissolution Baths which have not only differing degrees of sophistication but which also offer affordable options to cover all budgets Bath Drivers Available PHARMA TEST PTWS 310 PTWS 600 1200 610 1210 and DT series Others Varian Sotax Erweka Distek ask for details and models to be included Photometer Drivers Available PHARMA TEST SA 500 PDA Diode Array Photometer incl 8 or 16 cell changer T 70 UV VIS Split Beam Spectrophotometer incl 8 cell changer AGILENT 8453 PDA Diode Array Photometer incl 8 cell changer PERKIN ELMER Lambda 2 10 20 incl 8 cell changer Lambda Lambda 25 40 45 incl 8 or 16 cell changer parmi TEST eee Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 VARIAN Carry 50 incl 8 or 18 cell changer CECIL CE 2000 3000 5000 6000 8000 and 9000 series incl 8 cell changer JASCO UV 500 incl 8 cell changer BECKMAN DU 600 DU 7000 DU 9000 series incl 8 cell changer ANALYTIK JENA SPECORD incl cell changer THERMO Scientific EVOLUTION incl 8 or 16 cell changer Technical Data of the spectrometer will be listed in the quotation Pump Drivers Available Ismatec IPC 8 16 24 Watson Marlow PT P80 PT P160 CAT CAT 8 Piston Pump Technical Data PTWS310 Dissolution Bath 1 litre version 2 litre system available too Number of Stirring Positions 8 Stirrer Speed Adjustable within 25 250 rom accuracy
12. ovides the user with total management of the signing process from start to finish This includes configuring the number of signing levels the Users for each level Signer Activity and Meaning Group SIgning for Analytical Test a v Analytical Tester A Signer Action El SUPErvlSor H Signer Action PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER AO X MII B 49 6182 9532 600 49 6182 9532 650 i email pharma test de PHAR x www pharma test com 38 04450_ADS310_09 10E Page 7 of 16 lee Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 Signing and Reporting Signed Records Once data is acquired in a Group with signing rights any report generated will show the signing status for all pages of the record shown on the report gt a a b b Corrected Absorbance a Acetomenophen 250mg Stability Test 12345 Form 1 4567 Form 2 John Brown Quality Control SALESXPLAPKEITH Thursday September 30 2004 16 04 37 15 5 Data Unique ID SF82AA10 0E1F 468A 8614 117C7DF3CS13 Sample Dissolution 0 01 52 Time hh mm ss Technician Tested by John Brown 05 10 2004 09 50 Analyst Sign Off Signing Level Supervisor Requires Signing Signing Level Qualified Person Requires Signing PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER 38 04450_ ADS310_09 10E E
13. plays the printed file image for verification a oe cc PHA ma LS Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 User Queryable Audit Trail WinDiss32 Audit Trail lists all user activity that creates deletes or modifies i e from logging on and off to editing of method and data records This Audit Trail can be queried to limit the volume of information from a search and the results from any search can be printed Change Comment E Group Method Development has been given the ight Method Create Method inian Administration Set the user John in group Method Development not to use the group rights but use s se igh rer adn System Administration Set the user Patrick in group Method Development not to use the group rights but use System Administration set rights User Patrick in group Method Development has been given the night Method Delet User Logged OF 171 System Log On Status Log On Failed admin logging on to level Device Management in group Analytical Des 172 ___ John _ System bog On Status_ User log on successful to level Device Management in group Quality Control User Logged OF a los On Status Log On Failed keith logging on to level Application in group Quality Control 1175 John System Log On Status User log on successful to level Application in group Quality Control C e Run started for Data
14. pling and measurement Teflon tubing is connecting the Dissolution Vessels via an 8 channel Peristaltic Pump IPC 8 to the multiple cell changer inside the spectrophotometer of your choice see also Driver List Information As with nearly all sampling systems re usable in line filters are attached to the sampling tubes which are only placed in the dissolution vessel while sampling whenever the EPE Sampling System is used Sampling position distance and dimensions are according to the STV a f A C IZ LON 1 rn Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 USP directive which states that the sampling point must be exactly half way between the dissolution medium surface and the top of the stirring tool Paddle Basket or TD cylinder At the appropriate pre programmed time the EPE will drive down into sampling position the pump will be switched on and the sample tubing lines to the cuvettes are filled The pump will be stopped and the spectra measured are transferred from the spectrophotometer to the WinDiss32 Software for further processing Also stirring speed bath and media temperature optional sampling and measuring time are logged The ADS 310 is also be fitted with an online temperature monitoring device ITM connected to the EPE system This does record and log the actual media temperature inside the dissolution vessels while sampling As the PTWS 310 is fitted with 8 vessels then cuvette
15. ss32 Software Design System components Create and file Testing Methods including instrument control data Program single ob multiple calibration data Select single or multi component analysis Read single multiple wavelength or full scan File all data immediately after collecting no information loss at all Operate Single or Dual Systems Includes User Manual IQ and OQ Documentation needs to be ordered Available ADS System Options Select other PTA Dissolution Bath or even use existing instruments Ham TEST eee ae Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 Select other UV VIS Spectrophotometer having multiple cell changer Operate 12 vessel or dual bath systems Include Auto Sampler for sample dilution or sample processing prior to injection and measurement System Validation System validation can be done using the USP Reference Standard RS Tablets and Standards Supply scope includes full IQ OQ documentation for the supplied hard ware Installation and Qualification The dissolution system installation and qualification may be performed at installation by a Pharma Test trained engineer or agent All IQ and OQ paperwork supplied as standard Powerful dissolution result reporting software to generate individual report sheets including both results and graphics WinDiss32 is installed under Windows NT or 2000 XP GB or US Version Other factors influencing
16. tegrated into WinDiss32 Dissolution Data management software which is used by the worlds largest Pharmaceutical companies Driver Linkage with Unique Solution Path Technology Port 2 E A Icalis ASP2000 Autosampler 4 Icalis ASP2000 HPLC Injection Valve e WinDiss32 Supports a wide range of Baths Auto samplers war Fraction Collectors Pumps and other Detectors 1 ae y Vankel Bath 7020 Series 3 7 Port 5 e It uses a Unique Solution Path Technology rae SEE EARE f i i En E Metrohm 691 pH Meter e Configuration for different analysis requires no additional e reprogramming Pipe i 7 E cvo XL3000 8 Syringe Diluter e Support for Closed and Open Loop for UV and HPLC So systems PTWS e WinDiss32 can operate with USP I II Ill and IV methods e Expanded capability for HPLC e Collect and store samples in Auto samplers to perform online dilution mixing and measurement on the ADS Data collection rate The user can enter multiple data collection times during the entire dissolution run thus allowing more data points when active dissolves quickly and less towards the end of the profile Ham TEST ee ae WE Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 FDA 21 CFR part 11 Compliance The WinDiss32 Administration allows the system administrator to enter details of users to access the system The user Logon name full name and password are conf
17. tic beam coupler eliminates the requirement for mirror switching at the light source change from D gt to Tungsten lamp as found in conventional spectrometers The overall result is improved reliability and long term system stability The cell holder will take flow cells with a maximum path length of 20 mm as well as common 10 mm cells with a path length down to 0 1 mm The specially developed fibre optic technology used in the SA 500 is combined with a unique diode array detection module to give a unit which features very low energy losses compared with conventional optical systems These higher energy levels permit more rapid scanning of the array than is found in more conventional detectors resulting in a much faster scanning capability for a given signal to noise ratio This is the only technology which allows real time data acquisition of complete spectra at very high speeds e g in 12 milliseconds As the SA500 spectrophotometer is made by us you will be safe for correct and trouble free installation and operation as well as full Support and service supplied by us ob our local agents who are all well trained and able to offer all necessary qualification and validation assistance Instead of using the SA500 DAD Spectrophotometer you are able to include any of the instruments which are listed The T70 Split Beam UV VIS Spectrophotometer The T70 Split Beam UV VIS Spectrophotometer offers a wavelength range of 190 1100nm and is delivere
18. um flow rate Maximum flow rate Accuracy and precision PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER Teflon Tubing using fast connectors tube internal diam 1 0 mm for low volume outside the dissolution vessels manual or automated tablet drop magazine introduces tablets simultaneously when system ready for test Plexiglas plate holding 8 cleaning beakers to be used to flush all tubing and cells when test is finished Includes User Manual IQ and OQ Documentation Ismatec IPC Pump Ismaprene ENE 021 adjustable typical flow rate for dissolution approx 5 ml min depends on pump tubing usually 5 of volume rate 8 or 16 RS232 or TTL Includes User Manual IQ and OQ Documentation 8 200VCS stainless steel silent version approx 200 micro Itr 0 15 ml min 20 ml min lt 1 over full range excluding external factors such as tubings etc ry 49 6182 9532 600 N Z 49 6182 9532 650 D lt email pharma test de PHAR x www pharma test com 38 04450_ADS310_09 10E Page 13 of 16 Tae Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 Pump connection Tubing Interface Documentation SA500 Diode Array Photometer 1 4 28 UNF for PTFE connectors 1 0 mm ID 1 6 mm OD PTFE FEP tubing not included Rinse pump type HPLV 20V is included and is connected to all 8 pump heads RS 232 and I O port Includes User Manual IQ and OQ Documentation Optical System
19. ump and a spectrophotometer of your choice A state of the art Dissolution Bath Type PTWS 310 with 8 vessels Incorporated tablet drop magazine and removable sampling manifold EPE An 8 channel peristaltic pump equipped with Ismaprene tubing Teflon based sampling systems which are transferred from the vessels via the peristaltic pump to the spectrophotometer and the inside flow cells and back to the vessels closed loop There will be no cross contamination ob volume loss due to the individual closed loop system design Using the PTWS 310 and EPE Auto Sampling System the sampling probes are being removed after each sampling sequence The flow cells which have to be used are available with different path length to suit your measurement needs Depending on the maximum concentration you will be able to use cells from 20 mm SA500 only an common 10mm path length down to 0 1 mm which corresponds to a dilution factor of 1 200 compared to a manual sampling procedure pHaam TEST Fully Automated Tablet Dissolution Testing System Type ADS PTWS310 The SA 500 UV VIS Diode Array Spectrophotometer The SA 500 has a built in 8 cell changer 16 cell optional The cell changer compartment is not covered and is therefore easy to access Thanks to the cell holder design all of the installed UV cells are correctly positioned in the light path The use of fibre optic light transmission allows an optical system design without moving parts A fibre op
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