The PTWS 610 6+2-station Dissolution Bath is
Contents
1. as measuring speed or spectra scanning should be done we recommend the use of a PDA Diode Array UV VIS Spectrophotometer Any of the possible Spectrophotometer Types which can be included needs to be equipped with a 6 to 8 cell changer The cell compartment should have enough space to connect the required Tubing and allow free movement of the cell changer during operation The SA 500 Diode Array Spectrophotometer If a SA 500 Diode Array Photometer is included into the system all major components are made and supplied by us which mean trouble free and reliable operation during the full live cycle of the system 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 optic beam coupler eliminates the requirement for mirror switching at the light source change from Dz 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 giv2. 6 nm 0 3 nm 0 07nm 2 5 x 10 AU 5 x 10 AU lt 0 005nm C n gm 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 PTWS610 Scattered light lt 0 1 340nm D2 lamp Data Integration Data integration time approximately 100ms per channel Flow cell compensation Work with either absolute or baseline corrected absorption data 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 WinDiss32 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 Ham TEST ee ae eee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 I
3. LLL Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 PHATM gh Ter Staggered or simultaneous stirrer start manual or automated operation is offered by the advanced ADS PTWS610 System It includes an Ismatec Multi Channel Peristaltic Pump and a SA500 UV VIS Diode Array Spectrophotometer or a T70 UV VIS split beam UV VIS Photometer with 8 cell changer The fully automated closed loop Tablet Dissolution Testing System is controlled by the WinDiss32 Software Suite which is fully 21CFR Part 11 compliant The PTWS 610 6 2 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 bath 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 sampling and measurement Teflon tubing is connecting the Dissolution Vessels via an 8 channel Peristaltic Pump IPC 8 to the Photometer with its built
4. NE 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 litre 0 15 ml min ry 49 6182 9532 600 N Z 49 6182 9532 650 D lt email pharma test de PHAR x www pharma test com 38 04501_ADS610_09 1 0E page 13 of 16 eee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 Maximum flow rate Accuracy and precision Pump connection Tubing Interface Documentation SA500 Diode Array Photometer 20 ml min lt 1 over full range excluding external factors such as tubing etc 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 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 PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER 38 04501_ADS610_09 1 0E 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
5. S spectrophotometer of any other branch possible to be connected into the system if equipped with 8 cell changer 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 or volume loss due to the individual closed loop system design Using the PTWS 610 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 and 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 PTWS610 The Photometer We offer different Spectrophotometer Drivers which may be incorporated into the ADS PTWS610 Auto Dissolution Test System Depending on the application the system should be used for the user may select between single beam split beam and double beam Photometers or Diode Array Detectors The use of a single split or double spectrophotometer is possible if only single or multiple wavelength tests with now timing problem have to be performed As soon
6. ackages 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 PTWS610 system The ADS system offers an auto dissolution package incorporating validated systems A state of the art Dissolution Bath Type PTWS 610 with 8 vessels Incorporated tablet drop magazine and removable sampling manifold EPE A Pharma Test T70 split beam Photometer or a PDA Diode Array SA500 Diode Array UV VI
7. e 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 The T70 Split Beam UV VIS Spectrophotometer The T70 Split Beam UV VIS Spectrophotometer offers a wavelength range of 190 1100nm and is delivered 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 gt Excellent reproducibility and drift stability gt Integrated 8 way UV cell changer for 10x10 mm flow cells pHaam TEST LK Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 gt high performance characteristics gt flexibility gt user friendly operation Reproducible measurements 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 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 Spectrophotomet
8. e up time including heater start Vibration Absorber The water bath is placed onto 4 Vibroban vibration absorbers measurable vibration at the vessels less than 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 Ham TEST ee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 Sampling System 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 Minimum flow rate PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER EPE auto sampling system including 10 micron PP sinter filter attached to each sampling ferrule 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 E
9. ent 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 Dev 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 Fun started for Data ID BB6F5ACF C19C 4BFS A56E GD45CA7B167E a Run completed for Data ID BB6F5ACF C19C 4BF9 A56E 6D45CA7B167E Method Re saved Changing its ID to 13 7A1C05 65CB 4ADF GE 77 26 7F 13 765EAP trom 4 H 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 workstati
10. er 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 ob multi component analysis The ADS System components are controlled and integrated into WinDiss32 Dissolution Data management software which is used by the worlds largest Pharmaceutical companies Driver Linkage with Unique Solution Path Technology 7 IDIS EE Driver Administration x E File Devices User Help 15 x asea m Computer e WinDiss32 Supports a wide range of Baths Auto samplers Fraction Collectors Pumps and other Com 1 Detectors S E Icalis Rss EY RS232 El Port 1 It uses a Unique Solution Path Technology ea _Y Port l l l T ai 4 Icalis ASP2000 Autosampler e Configuration for different analysis requires no additional reprogramming aiy T e Support for Closed and Open Loop for UV and HPLC wae systems PTWS F mead i e WinDiss32 can operate with USP I Il Ill and IV a een H Port 7 methods E Icalis MSV300 2c H9 1 0
11. i F Port 8 e Expanded capability for HPLC j a Cavro XL3000 8 Syringe Diluter A 12c i E9 1 0 e Collect and store samples in Auto samplers to perform Uff Rs81 0 online dilution mixing and measurement on the ADS Lip eee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 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 FDA 21 CFR part 11 Compliance oe Administration 3 Groups Administration Group H Analytical Development E Quality Control Password Settings H 2 Group Access Rights E S Users A Denise 4 John fi Keith ais K Townsend Password D Use Group Access Rights Log on Levels Method Data Yo Query Data Ye Print Data Query C Delete Data Yo Post Edit Calculations 1 Y gt Post Edit Calculations 2 and Group Settings Yo Post Edit Run Options gt Post Edit Sample Details Y gt Post Edit Standard Details Yo Post Edit Batch ID and UDFs Yo Post Edit Flow Rates Y gt Post Edit Sample Weights Yo Save Post Edit Data Yo Export Method and Data H E Report 4 Group m4 Inactive Groups Inactive Users Configurable Centralised Security The WinDiss32 Administration allows the system administrator to enter details of users to access the system The user Logon name f
12. ificant 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 pHaam TEST
13. in 8 cuvette changer All instruments are controlled by the WinDiss32 Software which has to be installed to a suitable PC 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 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 fmenssvasseS n 49 6162 On co PHAR ma ee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 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 PTWS 610 can also be fitted with an optional online temperature monitoring device ITM connected to the EPE system This will monitor and log the actual media temperature inside the dissolution vessels while sampling As the PTWS 610 is fitted with 8 vessels then cuvette 8 can be filled with a fresh Reference Standard Cuvette 7 is connected to vessel 7 which ma
14. ncludes User Manual IQ and OQ Documentation needs to be ordered Available ADS System Options Select other PTA Dissolution Bath or even use existing instruments 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 Tablets and Standards Supply scope includes full Q 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 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 sign
15. o 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 T i x Output File Mame E RAPHI 15Faracetamol TIF Format TIF Browse File Format TIFF 24 bit color PackBits Page Format Multiple Pages Per File 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 displays the printed file image for verification aLa Doiie PHA m LL Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 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 al A Group Method Developm
16. on 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 04501_ADS610_09 1 0E page 10 of 16 LL Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 IDIS EE HPLC VYorkstation 2 IDS EE Database on Network Server eE a i ere M l E PLE Workstation 1 f E n E IDIS EE fClient HPL System 1 i mE HPL workstation 2 HPLC 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 complete 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 Others Photometer Drivers Available PHARMA TEST AGILENT PTWS 310 PTWS 100 600 1200 610 1210 and DT series Varian Sotax Erweka Distek ask for details and models to be included SA 500 PDA Diode Array Photometer incl 8 or 16 cell change
17. r T70 Split Beam UV VIS Photometer incl 8 cell changer 8453 PDA Diode Array Photometer incl 8 cell changer Ham TEST ST ee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 PERKIN ELMER Lambda 2 10 20 incl 8 cell changer Lambda Lambda 25 45 incl 8 or 16 cell changer 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 8 or 16 cell changer THERMO Scientific EVOLUTION incl 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 PTWS 610 Dissolution Bath 1 litre version 2 litre system available too Number of Stirring Positions 8 Stirrer Speed Adjustable within 25 250 rom accuracy 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 wak
18. ull name and password are configured 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 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 Global Settings Password Expire and Reuse l Admin Help Required Prompt l Audit Trall Log Un Log Un Failure Frompt l Password Expiry Prompt Log Off Times Log On Tries C No Check Log On Attempts C No Check Number of Attempts Attempt Time Period Eee Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 WinDiss32 provides 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 Signing Level User Lists Items IM Data Should be Signed Methods Should be Signed I s Analytical Tester Signer Action E LJ Meaning El SUPEMVelSOr B Signer Action Cancel M EB PHARMA TEST AG Siemensstrasse 5 D 63512 Hainburg GER 49 6182 9532 600 49 6182 9532 650 email pharma test de PHAR x ww
19. w pharma test com ID X 38 04501_ADS610_09 1 0E page 7 of 16 lle Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 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 Data Unique ID Acetomenophen 250mg Stability Test 12345 Form 1 4567 Form 2 John Brown Quality Control SALESXPLAPKEITH Thursday September 30 2004 16 04 37 15 5 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 04501_ADS610_09 1 0E E E X mi page 8 of 16 Page 1 of 1 49 6182 9532 600 49 6182 9532 650 email pharma test de PHAR www pharma test com lle Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 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 log
20. y 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 Photameter cell changer Bland and Reference Media Wessls Fully Automated Tablet Dissolution Testing System Type ADS PTWS610 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 using the new fully 21 CFR Part 11 compliant WinDiss32 software and is by definition PC controlled The overall structure of both software p
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