Fully automate the process of bubble-point 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 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 
  • Minimize operator's exposure to radioactivity 
  • Record and store results in a non-editable log

The Filter Integrity Tester has 6 key benefits:

True bubble-point

Calibrated pressure sensors are used to measure gas pressure and deliver the true bubble-point.

Eliminating specific bubble-point pressure calibration

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

There is 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 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 user's perspective both types of filters are tested in the exact same way. No need to seal vent holes.

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

Contact LabLogic’s service support team at support@lablogic.com to schedule a service engineer to come out on site to calibrate your Filter Integrity Tester.

Option 2

Ship the Filter Integrity Tester back to LabLogic and we will perform the calibration and have it shipped back to you.

Test history and data logging

Each test is logged with all details including Date, Time, Test ID, Bubble-point test pressure, Measured bubble-point and Test result. Data is stored on the device and can be downloaded as an Excel file or PDF onto a computer by USB connection.

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 2

Wet filter

Load up to 35 mL of wetting solution (usually water) into the solution reservoir. The solution will be pushed through the filter to wash off residual product which could alter the bubble point. This step standardizes 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.

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 35 mm diameter
Filter wetting  Yes, by loading internal 40 mL reservoir 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 15 cm x H 23.5 cm H 15 cm (W 5.9” x H 9.3” x D 5.9”) 1.9kg (4.2 lbs)

Documents

The LabLogic Group will always treat your details with the utmost care and will never sell them to third party companies.

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