Filter integrity testing in pharmaceutical industry l Interview Questions

Filter integrity testing in pharmaceutical industry l Interview Questions
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Questions covered :
Q.1 : What is filter integrity testing in pharmaceutical industry.
Filter integrity is test performed to confirm structural integrity of sterilizing filter.
Filter Integrity Test is done to check the filter leakage / blockage or gross failure.
Q.2 : Why filter integrity testing is done ?
Reason for performing filter integrity test is to ensure the intactness of filter used and reduce the risk for the process wherein filter was used.
FDA’s guideline on sterile drug products produced by aseptic processing (1987) recommends for filter integrity testing.
Q.3 : When filter integrity testing should be done
Commonly, filter integrity testing is done after the filter unit is installed and prior to use of filter.
More importantly such testing should be conducted after the filter is used for intended use to identify any filter leaks or perforations that may have occurred during filtration process.
Q.4: Methods for filter integrity testing.
Non-destructive methods
1. Forward flow/diffusion test
2. Bubble point test
3. Pressure hold test
Q.5: .What are the filter related potential causes of integrity test failure :
Membrane damage
O-ring damage
Device damage
Poor wetting
Wrong membrane
.6 What are the test method failure modes for integrity test failure ?
Improper wetting of filter
Wrong test selected
Leaks
Valves improperly open or closed
Untrained operator
Wrong wetting fluid
Q.7 What are the basic types of filters used in pharmaceutical industry?
Hyodrophilic filters
Hydrophobic filters
Hydrophobic filters are ideal for air or gas filtration, they are not suitable for filtering aqueous solutions.
Hydrophilic filters are commonly used for filtration of water based fluids
Q.8 What are the commonly used filter integrity test machines?
Sartocheck 4, Sartocheck 4 plus, Sartocheck 5 plus integrity test machine
Merck Millipore filter integrity machine
Pall filter integrity tester
Q.9 Is repeat attempt is allowed for filter integrity test failure?
Yes. Repeat attempt is allowed to identify any test method used or instrument related error during testing.
Any number of re-tests might be considered if the root cause of the previous test result can be clearly identified and documented.
Q.10 What should be the action plan if product is not available for post use filter integrity testing?
Integrity test shall be carried out using vendor recommended wetting fluid i.e. WFI or IPA-water combinations.
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