Integrity tester

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hi all,

Does anyone know how to validate a filter integrity tester? There are different tests, like bubble pointe, diffusion, water intrusion et al. how to decide the parameters for each test? are they coming with the filters?

thanks

2

Usually IQ/OQ protocols for Filter integrity tester comes with equipment. These are OQ tests:

• Pressure regulation
• Volume Measurement Verification Test
• Leakage test and Bubble Point Measuring Range Verification
• Diffusional Flow test and Bubble Point Resolution
• Water Intrusion Test/Water Flow Measurement
• Selection accuracy
• Filter failure detection
After initial qualification FIT is in regular maintenance and calibration program

3

For the bubble point test validation:

Attach a calibrated pressure gauge in the upstream of filter system, record the pressure of the gauge and compare it with the printout to see if both match.

For diffusion test validation:

Connect a tube from down stream of the filter system to a beaker filled with water, put a graduated cylinder in a inverted way below the water, and put the tube inside the cylinder, start the test, measure the water volume expelled from the cylinder in time unit and compare that to the printout.

The above methods are correct?

We have Sartocheck 3 integrity tester and Pall flowstar integrity tester, should each test their own filter ie filters from Sartorius be tested with Sartocheck3 and filters from Pall must be tested with Pall flowstar tester?

thanks for explanation!

4

[quote=Hanks]For the bubble point test validation:

Attach a calibrated pressure gauge in the upstream of filter system, record the pressure of the gauge and compare it with the printout to see if both match.

For diffusion test validation:

Connect a tube from down stream of the filter system to a beaker filled with water, put a graduated cylinder in a inverted way below the water, and put the tube inside the cylinder, start the test, measure the water volume expelled from the cylinder in time unit and compare that to the printout.

The above methods are correct?

We have Sartocheck 3 integrity tester and Pall flowstar integrity tester, should each test their own filter ie filters from Sartorius be tested with Sartocheck3 and filters from Pall must be tested with Pall flowstar tester?

thanks for explanation![/quote]

For diffusion test validation:

  • Connect a ball valve together with pressure sensor on top of the housing
  • Link the open end of the ball valve to a pressure source of 4-5 bar (e.g. line pressure)
  • Close the ball valve.
  • Start the test (p=2800 mbar) and when the stabilization phase starts open the ball valve slowly until the pressure is about 50 mbar higher than the target value.