Dissolution Automation: Off line Systems

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1 Dissolution Automation: Off line Systems Designed specifically for Tablet Dissolution testing, this unique versatile system allows samples to be collected over very short Time Intervals with additional dilution and injection of samples for UV-Visible measurements or into an HPLC in real time. The PTWS 310 off-line system with the ASP 2000 and WIN-DISS 32 Software introduces a new level of sophistication in Tablet Dissolution that allows simultaneous Collection, Dilution and Reagent Addition with subsequent injection for UV or HPLC analysis in real time. Also shown below is the optional SA500 Diode Array Spectrometer with single, 8 cell or 16 cell changer. Most operations are performed with a Bath integrated into the system. However, the AUTO SAMPLER and sample preparation features can be used to process samples collected by other means, i.e., samples that are manually collected or collected by conventional Fraction Collector PTFC2 etc. The ASP2000 utilises two probes; a Multiple Probe consisting of up to 8 Needles which can be used for sampling and a Single Needle Probe can be used for Dilution and or Injection. This popular configuration is elaborate, but allows also calculation of results if samples are injected into a connected UV/VIS spectrophotometer using the new fully 21 CFR Part 11 compliant WINDISS-32 software and is by definition PC controlled. The overall structure of the software package and their programming options is the subject of another publication called: Dissolution Automation: Keypoints for Consideration The use of the RS8 multiple interface also eliminates worries about PC configuation. Modern PCs normally only have 1 COM RS232 and a USB Comm. Port. The RS8 has multiplexed RS 232 comm ports as well as switched I/O ports for both serial port instrument control and closed contact applications (e.g., pump switching) _ASP2000_04.02 Page 1

2 Collection, Dilution and Injection with WIN-DISS32 and a Diluter Dispenser Collects samples sequentially or simultaneously when used in combination with a Dissolution Tester, WIN-DISS 32 Software and a Diluter Fraction Collection or Sample Collection using a Flow Through Rack. Works in combination with 2 Baths with the Sample Collection - Flow Through Rack. WIN-DISS 32 Deferred Data Analysis allows accurate Collection Times while maintaining high throughput sample processing in real time for UV and HPLC analysis. Fraction Collection Fractions can be collected from the Bath directly into the ASP2000 Needles into Tubes or HPLC Vials. Collection Times for all Samples as short as 3 minutes can be achieved. Icalis PCP490 PCP1 NC NO C Icalis MSV300 Media Switcher I C A L I S 2 A SP Demo Bath 1 Icalis ASP2000 Autosampler ASP _ASP2000_04.02 Page 2

3 Sampling using the Flow Through Rack Using a Multiple or Single Syringe Diluter Dispenser, Samples are pumped into the Flow Through Racks and returned to the Bath. At the Sampling Times, samples are drawn from the Flow Through Racks by the Diluter and into the Sample Vials in the Rack. This configuration can work in combination with up to 2 Baths with Sampling intervals greater than about 5 minutes when the Multiple Needle probe is used ASP I C A L I S Demo Bath Icalis ASP2000 Autosampler ASP01010 Cavro XL Syringe Diluter Pump _ASP2000_04.02 Page 3

4 Offline (or Online) HPLC or UV Analysis The ASP2000 in combination with a Diluter and the WIN-DISS32 software allows simultaneous operations for Sampling, Dilution, Injection and measurement with a UV-Visible spectrophotometer integrated into the system. There is no need for any sample handling by the User once the test has started. For UV analysis, unlimited Standards and or Blanks can be measured at the beginning or during the test and results are displayed in real time with compensation for Media Loss and or Replacement Spectrophotometer Demo1 Cavro XL ASP I C A L I S Demo Bath Icalis ASP2000 Autosampler ASP01010 Pump 1 For HPLC analysis, the ASP2000 can be fitted with an optional HPLC valve Cavro XL Syringe Diluter Demo Bath 1 AS P2 000 I C A L I S Icalis ASP2000 HPLC Injection Valve ASP01010 Generic HPLC Device Generic HPLC Icalis ASP2000 Autosampler ASP01010 Cavro XL3000 Cavro Single _ASP2000_04.02 Page 4

5 Using WINDISS 32 Deferred Data Collection functionality, Samples can be injected into the HPLC and the Integrator triggered during the dissolution tests while still maintaining the collection times, thus utilising valuable time. PTWS Position Dissolution Tester Technical Data: Display: LCD Digital Display (10 x 10 cm illuminated) for RPM, temperature, time, timer and ph (optional) functions Keyboard: Function and alpha-numeric keys Interface: 1 RS-232 port 1 TTL relay port to connect a PTFC 2 Fraction collector and a pump 1 ph-probe port Printer: Built-in Thermo Printer, prints test log as well as OQ informations Speed control: adjustable from 20 rpm rpm Accuracy: ± 2% of set speed typically < 1% Temperature control: 1000 W heater and pump system, protected against overheating and "no water" operation, adjustable from about 25 C - 50 C, water diffuser for even water distribution all over the bath Accuracy: ± 0.2 C inside the water bath ph measurement * : Accuracy: ± 0.02 ph units Number of stirred vessels: 8 vessels for buffer / medium Heat-Up: Energy saving, programmable, "auto start" heater function Calibration: built-in calibration procedures for speed, temperature control and phprobe, OQ/PQ sequence programmable including alarm indicator Stirrer wobble: better than 0.2 mm Vibration inside vessels: less than Hz Vessel Centring: auto centring inside the bath cover, easily aligned bath using centring tools and stainless steel support dish Evaporation Covers: provided for all vessels with suitable tool / sampling tube cut outs Validation: All IQ & OQ paperwork included ASP 2000 Fraction Collector and Sample Preparation Station Technical Function Data: External Control: Output Control Option: Dimensions: Usable Area: Probe 1: Probe 2: Travel Speeds: RS232, TCP / IP 2 x SPCO Relays: ratings: 24V DC or 50V AC 55 x 67 x 46 cm (Width x Depth x Height) 38 x 34 cm (Width x Depth) Single needle with 140mm travel 8 Needle Carriage with 100mm travel X Direction: -2 to 180 mm/s Y Direction: -3 to 180 mm/s (Single Needle) Y Direction: -3 to 180 mm/s (Multiple Needle) Z Direction: -5 to 200 mm/s (Single Needle) Z Direction: -5 to 200 mm/s (Multiple Needle) _ASP2000_04.02 Page 5

6 SA500 Diode Array Spectrophotometer Technical Data Light Source D 2 and Tungsten lamps Lifetime: D 2 lamp has a life of approx hours Wavelength Range nm Maximum measurment speed 12 ms / Spectrum Number of Diodes 1024 Optical Grating 248L/mm Spectral Resolution 0.8 nm/pixel Spectral Bandwidth 1.6 nm Wavelength Accuracy 0.3 nm Wavelength Precision ± 0.07nm Noise (at 580nm) ± 2.5 x 10-5 AU Baseline Drift 5 x 10-4 AU Temperature Drift < 0.005nm / C Scattered light: < 340nm (D 2 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 _ASP2000_04.02 Page 6

7 WINDISS 32 Software The Off Line Dissolution System is controlled and integrated into WINDISS 32 (Icalis IDIS EE) Dissolution Data management software which is used by the worlds largest Pharmaceutical companies. Driver Linkage with Unique Solution Path Technology WINDISS 32 Supports a wide range of Baths, Autosamplers and Other Detectors It uses a Unique Solution Path Technology - Configuration for different analysis requires no additional reprogramming. - Support for Closed and Open Loop for UV and HPLC systems. - WINDISS 32 can operate with USP I, II, III and IV methods. - Expanded capability for HPLC - Collect and store samples in Autosamplers to perform online dilution, mixing and measurement on the ADS. FDA 21 CFR part 11 Compliance The WINDISS 32 Administration allows the system administrator to enter details of users to access the system. The user Logon name, full 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 _ASP2000_04.02 Page 7

8 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 WINDISS 32 networked workstation _ASP2000_04.02 Page 8

9 WINDISS 32 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 _ASP2000_04.02 Page 9

10 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 _ASP2000_04.02 Page 10

11 Dynamic Report Editor The WINDISS 32 report organiser allows users to produce customised 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 WINDISS 32 is supplied with the Icalis Graphics Printer that provides compliance with 21 CFR Part 11 requirements for human readable form. These reports can be circulated, ed etc., in the safe knowledge that they are non-editable. 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 _ASP2000_04.02 Page 11

12 User Queryable Audit Trail WINDISS 32 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 _ASP2000_04.02 Page 12

13 Networking Our networked system provides a central relational database that contains all data (methods and data records) from all WINDISS 32 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 _ASP2000_04.02 Page 13

14 Bath Drivers Available: PHARMA TEST: PTWS 310, PTWS 600, PTS 1200, DT series Photometer Drivers Available: PHARMA TEST: AGILENT: PERKIN ELMER: VARIAN: CECIL: JASCO: BECKMAN: SA 500 PDA Diode Array Photometer incl. 16-cell changer 8453 PDA Diode Array Photometer incl. 8-cell changer Lambda 2/10/20 incl. 8-cell changer Lambda Lambda 25/45 incl. 8 or 16 cell changer Carry 50 incl. 8-cell changer CE 2000, 3000, 5000, 6000, 8000 and 9000 series incl. 8-cell changer UV 500 incl. 8-cell changer DU 600, DU 7000, DU 9000 series incl. 8-cell changer Technical Data will be listed in the quotation Pump Drivers Available: ISMATEC: IPC 8, 16, 24 CAT: CAT 8 Piston Pump WATSON MARLOW: PT-P80, PT-P _ASP2000_04.02 Page 14