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Filter Integrity Tester
Automated Filter Tester for
Radiopharmaceutical Quality Control
Easy, Quick & Accurate Filter Testing
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 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
Automated Filter Integrity Tester Demonstration video
3 Simple Steps
Step 1:
Set test pressure and test ID
Step 2:
Load solution, insert filter and test
Step 3:
Results either pass or fail
- Select parameters
Select pressure hold test time and bubble-point pressure as per filter manufacturer specification’s along with Test ID. -
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
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 the pressure result.
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.
Vented and Non-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
There are two 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
Multiple unique users can be set up
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 as a non-editable PDF file onto a computer by USB connection.
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
17cm
23cm
17cm
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.
Compressed Air
Waste bottle
24V power supply
Frequently Asked Questions
Question: Can the Filter Integrity Tester be connected directly to a Printer?
Answer: No, to print reports the FIT has to be connected via usb cable to a PC where reports can be downloaded and printed.
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Question: Can the Filter Integrity Tester be controlled remotely?
Answer: No it is a standalone device and can only be controlled by the touch screen.
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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.
The touchscreen could be operated by teletongs if you can grasp a stylus with the teletongs to simulate a finger. To load the wetting solution, a 1/16" tube could be connected to the device and the tube routed to outside the hotcell with a syringe on the end to remotely push the wetting solution into the devices loading vial.
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