Filter Integrity Tester v2
Automated Filter Tester for
Radiopharmaceutical Quality Control
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Easy, Quick & Accurate Filter Testing
Our second generation 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 sterilizing filters used in radiopharmaceutical quality control.
The Filter Integrity Tester is designed to replace manual bench top systems or manual methods of testing sterilizing 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 non-editable log
3 Simple Steps
Step 1:
Select filter,
enter test ID
Step 2:
Load solution, insert filter & test
Step 3:
Results:
Pass or Fail
- Select parameters
a. Select Filter to be tested then enter Filter reference.
b. Optional step: Create custom test (define your filter parameters, pressure hold test, bubble point test, vented or non vented, wetting pressure). -
Test Process:
- 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. - Pressure hold test (optional)
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. - 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.
- Wet filter
- Results
Once the test is complete the filter integrity will display a pass or fail screen with a test summary.
Key
Benefits
- Calibrated pressure sensors are used to measure gas pressure and deliver the true bubble-point.
- Filters are wetted prior to the test to standardize the test to the filter manufactures specifications which eliminates the need for any product specific bubble-point pressure calibration.
- Installation independent results - No need to calibrate pressure drop between the test devices pressure meter and the filter if the filter is located some distance away from the test device.
- Compatible with both non-vented and vented filters.
- Title 21 CFR Part 11 compliant software.
- Record and store results in non-editable log.
- Compatible with all wetting solutions methanol and water.
- Remote access and control via network interface (pc, tablet or phone).
- Prints reports directly to networked printer.
- Vaporized Hydrogen Peroxide (VHP) sterilization compatible.
- Multiple languages such as English, German, French, Spanish, Mandarin and more.
Non-Vented & vented Filters
The Filter Integrity Tester can test filters up to 42mm in diameter and is compatible with both vented and non vented filters as the device automatically detects the filter type and applies the applicable gas flow profile.
This means that from the users perspective both types of filters are tested in the exact same way.
No need to seal vent holes!
Vented Filters
Non Vented Filters
Multi-user level access
Unlimited unique users.
Default user levels which can perform the following:
Administration User:
- Run tests
- Check results
- Edit user logins
- Configure instrument settings
- Perform sensor calibration
Generic User:
- Run tests
- Check results
Read only users:
- Check results only
Create custom users:
- Calibration staff
- QA / Audit accounts
Test History & Data logging
Test history page
Test report
Each test is logged with following details:
- Test ID
- User
- Date / Time
- Wetting solution temperature
- Pressure hold time
- Bubble Point limit
- Bubble Point result
- Test result.
Data is stored on the device and is non-editable.
Reports downloaded directly from device or usb can be connected to transfer reports.
Reports can also be printed directly from the FIT
21CFR-Part 11 compliant.
Audit log tracks user activity
Sensor Calibration
The Filter Integrity Tester requires the two internal pressure sensors to be calibrated once per year. This can be done in one of the two following ways.
- Option 1:
Attach a calibrated pressure meter to the device and calibrate the 2 internal pressure sensors using the calibration wizard (this takes about 5-10 minutes)
- Option 2:
Ship the Filter Integrity Tester back to IPHASE and we will perform the calibration and have it shipped back to you in no time.
Compact dimensions
15cm
16.1cm
23.2cm
Simple installation
Simply connect compressed air, power and waste bottle and its ready to go.
The Filter Integrity Tester is a non-shielded device, if testing radioactive filters then it needs to be located behind sufficient shielding.
24V power supply
Waste bottle
Compressed Air
Frequently Asked Questions
Question: Can the Filter Integrity Tester be used in ISO 5 environments or inside an hotcell?
Answer: The FIT was designed as a standalone bench top device to replace manual bubble point testing rigs. The wetting solution needs to be loaded by syringe into the device, the touchscreen operated to start tests, and filters installed onto and removed from the device.
If wanting to operate the device inside a hotcell remotely, teletongs would be required so long as they can be used to install and remove filters from the device. If the filters has a luer lock outlet fitting, the filter would need to be screwed on/off whereas luer slip outlet fittings could be simply pushed on/off.
