Filter Integrity Testers for the Pharmaceutical Industry

Transcription

1 Inline Filter Integrity Tests on Filters on huge Vessels, Freeze Dryers, Autoclaves, Filling -and Pressure Lines 1

2 The portable Filter Integrity Tester "it-01" The Filter Integrity Tester " it-01" can be used for integrity tests on membrane filters. In addition to integrity tests it is also possible to check unknown volumes (e.g. the upstream volume of a filter housing). The Instrument can also be used as a Calibration Pressure Gauge (Range 0-4 bar, 0-6 or 0-8bar) Membrane Filter Integrity Tests : Diffusion Test (Forward-Flow) Pressure Drop Test Diffusion and Bubble Point Test Diff.Tests with automatic filter wetting Water Intrusion Test (WIT) Water Intrusion Test on huge housings (150L) WIT Tests with automatic filter drying WIT Tests with automatic housing cooling Leakage Tests on sterile bags and containers Volume Measurement: Volumes Checks from 0.1 to 32L "it-01" is small and portable and can be easily used in inaccessable places e.g. on huge vessels and in autoclave rooms. Electrical Power: Selectable Battery or Mains driven. For the testing of small filters "it-01" has a special holder installed on the backside, e.g for small capsules, 50 mm Disposables, mini cartridges and injection filters. A pneumatic driven valve can be directly controlled by the instrument: e.g for the automatic wetting procedure, filter drying or filling of huge housings. 2

3 The Printer is waterproof inside the case behind the cover (No thermo printer!). A short Operation Instruction is shown on the main plate inside the instrument. Up to 100 filter test programs can be stored in the instrument`s memory and an unlimited amount on a PC. A software (Windows Xp) for the central administration of filter test programs is available. FDA Standard 21 CFR 11: A software version for this standard is available. Up to 40 filter test records can be stored in the instrument (only with CFR-version). PC-program for the Administration of Filter Test Programs(System Software: Windows>Xp.) With the software "it-trans" a lot of filter test programs can be created and administrated on a central place. If there are different instruments are installed in the company, the QA Administrator can create for every intrument the necessary filter test programs. The test programs are loaded in via interface cable. This high securety level guarantes, that the test programs can not be changed and the application is correct. 3

4 Explosion proof Filter Integrity Tester "it-01-ex" The Filter Integrity Tester " it-01-ex" is specially designed for the application in areas where an explosive atmosphere is possible (Ex-Zone 1). In addition to filter integrity tests it is also possible to check unknown volumes (e.g. the upstream volume of a filter housing). The Instrument can also be used as an Calibration Pressure Gauge (Range 0-4 bar) Membrane Filter Integrity Tests : Diffusion Test (Forward-Flow) Pressure Drop Test Diffusion and Bubble Point Test Water Intrusion Test (WIT) Volume Measurement: Volumes Checks from 0.1 to 32L The explosion proof Integrity Tester "it-01-ex" can be used in Ex-Zone 1 T4. "it-01-ex" is built small and compact, the cabinet is made of stainless steel ( electro polished). The "it-01-ex" is in accordance to the ATEX guidelines. It will be delivered with German TÜV and British BASEFA Certificates. Electrical Power: "it-01-ex" needs for operation an ex-proofed mains connector 110 or 220V /AC Line Pressure: 6 bar air or nitrogen. A separate source for nitrogen protective gas is not needed. 4

5 The 2-Channel Filter Integrity Test Station "ita-02-ts" for Membrane Filters The 2-Channel Filter Test Station carries out the filter integrity tests for two different filters simultanously. All usual tests like Diffusion Test, Bubble Point Test or Water Intrusion Test (WIT) can be used. The liquid filters are automatically wetted during the test procedure. The test records can be collected on a PC or printed out in place. Pressure range mbarg The 2-channels on the test station "ita-02-ts work independant and simulatanously e.g At the same time a On Channel 1 --> Diffusion-Bubblepoint Test On Channel 2 --> Water Intrusion Test Automatic Filter Wetting Procedure The wetting of filter membranes can be optimized (important at PES membranes). The wetting procedure is part of the integrity test. The Bubble Point Tester "it-bp" for the QA- Laboratory The Bubble Point Tester "it-bp" can be used for Bubble Point measurements on membrane filters. Caused by the huge measuring range 10 mbar mbarg also wiremesh filters, diaphragma or ceramic filters can be tested. The instrument is used for the quality comparison of different filter materials. 2 Versions are available: The low pressure version"it-bp-lp" Measuring Range mbar For wiremash filters, diaphragma filters and ceramic filters The high pressure version "it-bp-hp" Measuring Range mbar For membrane filters and ceramic filters 5

6 Calibration, Maintainance and Qualification : Once a year the sensor and the pressure control system have to be checked and calibrated. For maintainance and calibration the instrument normally has to be sent back to the manufacturer, a special transportation box is part of the delivery. For countries in the EU or Switzerland the maintainance work can also be carried out in place. All necessary measuring devices are DKD (Deutscher-Kalibrier-Dienst) certified. A continious controlled schedule for calibration of all measuring devices is guaranteed. Qualification (IQ, OQ,PQ): If an integrity Tester should be qualified, our qualification service will carry out dthe different parts according the the customers requirements. The qualification documents are created in English or German 6

7 Accessories: The Filter Testbox "itb-08" Up to 8 small disposable filters or capsules can be tested simultaneously in one test run (even injection filters). The filter holders are designed in such a way that most of the standard filters can be easily fixed. For filters with other dimensions, special adapters are available. The kind of filter testing: All filters are tested in parallel. When using the Bubble Point Test, the filter with the lowest Bubble Point Value determines the test result. For separate tests the filter holder on the instrument can be used. The complete test run as well as the wetting procedure of the filters is fully automatic. Installation: The Filter Test Box "itb-08" is connected on one side to the pressure vessel with the wetting medium and on the other side to the integrity tester "it-01" (see picture ). After teh test is started, the wetting fluid flows for a selected time through the filters. After that time the test run starts and the result is printed out after approx. 5 min. Remarks: If alcohol is used as weeting medium, and the box is sealed, the alcohol steam cannot leak into the room atmosphere. 7

8 Accessories:. The Low Pressure Testbox itb-lp for Leakage Tests on Sterile bags and Containers Description: The low pressure test box itb-lp is an accessory for the filter integrity tester it-01 Controlled by the integrity tester documented leakage tests on strile package bags and containers can be carried out. The leakage test can be done in a test pressure range between 50 and 500 mbar. How to operate the testbox "itb-lp? The inlet side of the testbox is linked to a line pressure source (1-3,5bar). The filling valve is taken away from the integrity tester. The low pressure testbox is plugged into the same connector On the outlet side of the testbox (Triclamp TC 1,5 ) a PTFE sterile filter capsule is mounted. On the sterile side of the capsule the sterile bag is fixed. The test program for the specific leakage test is started on the integrity tester. When the test is over, the sterile bag is emptied by the use of an inbuilt vakuum pump. Specifications: Cabinet Stainless Steel Cabinet Dimensions 200x300x80 mm Weight Pressure Line Connector. Press. Sensor Connector Press. Outlet Line Pressure: Test Pressure 2,5Kg Male Stäubli RBE 03 (1.4404) Male Stäubli RBE 03 (1.4404) Triclamp TC 50,5mm 0,5-3 bar Protection Classe IP mbar 8

9 Specifications: Housing material Stainless steel Housing size (without handhold, and holders) 200x300x155 Weight: 8,6 kg Protection classe: IP 55 Power Supply: Battery 7,2 V/ 3,8Ah (oder Mains) Keyboard: Infrared,alpha numeric (water protected) Software protection: Stored in flash EPROMs Matrix printer: Normal paper, 24 characters/ line Amount of storable test programs: 100 Kind of storage Flash EPROMs Pneumatic connectors: Stäubli RBE 03 / stainless steel Internal pressure sensor : mbar; rel. Class l 0.5 Barometric pressure sensor: mbar Class 0,5 External pressure sensor: mbar, rel. Class.0,15 Main CPU -board: HC-12 Motorola Program language: C Display: 4 lines illuminated - 20 characters/line Data transfer: RS 232 ( bd) Languages: Measuring units: Pressure : Water flow : Diffusion: Volume: Possible integrity tests: Cleaning of pneumatic parts: Measuring Accuracy WIT: Diffusion: Bubble Point German, English, French, Italian, Spanish, Danish, mbar µl/ t (test time) ml/min (1000 mbar /20 C) ml Water Intrusion Test (WIT) Diffusion Test, Pressure Drop Test Bubble Point Test, Diff.+Bubblepoint Test Volume Measurement Steaming of the external sensor and Filling valve Flushing of the internal valves (80 C) 4% of actual value >= 0.1mL/min max.resolution 0,008mL 5% of actual value >= 5mL/min max.resolution 0,1mL 1% F.S. Environment temperature: 5-40 C Storage temperature: 2-50 C Rel. huminity: 0-80% 9

10 Bat t. START STOP FUNCTI ON 0 ENTER OFF ON VOLUME i t -01 Bat t. START STOP FUNCTI ON 0 ENTER OFF ON VOLUME i t -01 STOP 1 2 FUNCTI ON 0 START i t -01 ENTER OFF ON VOLUME Filter Integrity Testers for the Installation: Water Intrusion Test (WIT) Installation: Water Intrusion Test (WIT) Press. Sensor Gas -Filter Installation: Water Intrusion Test (WIT) with Cooling Press. Sensor Overflow Valve Pressure Line 6-8bar Inlet Filling Valve Pressure Line 6-8bar Filling Valve Vent Filter on a T ank Press. vessel (it-006l) Installation: "Remote Controlled" Water Intrusion Test Press. Sensor Gas-Filter Inlet Pressure Line 6-8bar Filling Valve 6L Press. Vessel Sterile Area 10

11 Bat t. START STOP FUNCTI ON 0 ENTER OFF ON VOLUME i t - 01 Bat t. START STOP FUNCTI ON 0 ENTER i t -01 OFF ON VOLUME START STOP FUNCTI ON 0 9 i t -01 ENTER OFF ON VOLUME Filter Integrity Testers for the Installation:: Diffusion- Bubble Point Test and Volume Mesurement Pressure Sensor Filling Valve Filling Valve Liquid Filter Pressure Line 6-8bar Liquid Filter Pressure Line 6-8bar Inlet Inlet Installation: Diffusion Test Bubblepoint Test Ref erence Volume --> it > it-800 Volume Measurement Press. Sensor with Valve Group Vent-Nozzle Pressure Line 6-8bar Inlet Installation: Diffusion Test Bubblepoint Test with Filter Wetting Pneumatic Valv e for filter wetting Press. Regulator 0.5-->0.8 bar) 10L Pressure Vessel for the wetting medium (it-010l) 11

12 2-Channel Filter Integrity Test Station for wetting and testing of Membrane Filters 12