Automated Filter Integrity Tester
The Filter integrity tester is a compact standalone bench-top unit capable of fully automating the process of bubble-point testing commonly used vented & non-vented sterilising filters used in radiopharmaceutical quality control.
The Filter Integrity Tester is designed to replace manual bench top systems or manual methods of testing sterilising filters to enable the following:
- Automate testing with calibrated sensors
- Eliminate operator subjectivity of measurement
- Minimise operators exposure to radioactivity
- Record and store results in a non-editable log
The iPhase Filter Integrity Tester is has 6 key benefits:
3 Simple Steps
Step 1: Select parameter
Select pressure hold test time and bubble-point pressure as per filter manufacturer specification’s along with Test ID.
Step 2a: Wet filter
Load up to 35mL of wetting solution (usually water) into the solution reservoir. The solution will be pushed through the filer to wash off residual product which could alter the bubble point.
This step standardises testing and performs the process as per the filter manufactures recommended test procedure.
Step 2b: Pressure hold test
The test is started by pressure being slowly increased up to 80% of the bubble point pressure for a specific amount of time in which the system checks that there are no bubbles/pressure increase on the outlet of the filter.
Step 2c: Bubble Point Test
After the pressure hold test the Filter Integrity Tester slowly increases the pressure to check the bubble point. The Filter Integrity Tester will then record the pressure when bubbles appear/pressure increases on the filter outlet to determine the bubble point pressure.
Step 3: Results
Once the test is complete the filter integrity will display a pass or fail screen with the pressure result.
Technical Specifications
Test method | Non-destructive true bubble-point using calibrated pressure sensors |
Sterile filters | Non-vented and vented up to 35mm diameter |
Filter wetting | Yes, by loading internal 40mL reservior with desired solution volume |
Gas supply | Any gas 5-8 bar (73-116 psi), 1/8” OD push in connection |
Power supply | 110 V-240 V, 50/60 Hz |
Dimensions and weight | w 15cm x h 23.5cm d 15cm (w 5.9” x h 9.3” x d 5.9”) 1.9kg (4.2 lbs) |
Documents
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Automated-Filter-Integrity-Tester-EU-Version-1.0
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