Filter integrity testing in pharmaceutical industry l Interview Questions
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- Опубліковано 7 вер 2024
- 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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thank you so much sir i have getting more useful information
Thanks
Please do a video on integrity pressure hold test, forward flow rate method and bubble point procedure
Ok. You will get that very soon.
Thank you sir... Can you please make a video about NVPC
I have already done this.
ua-cam.com/video/Pz1KCzQOGfg/v-deo.html
Ok thank you 😊
Hydrophobic use for water and hydrophilic use for air and gas please correct it
Thanks for update 👍
Thank you
Thanks for comment 👍
👑👍👍👍
Thanks
Bro thanks for the information. You got anything on centrifuge?
Thanks. I will make video on centrifuge.
Which guidelines we are following for bubble point test?
PDA Technical report No. 26. Revised 2008
Sir I have one question...which steps involved in during filters integrity tests
You can refer below steps for filter integrity testing,
• Prepare the filter integrity testing equipment, including the integrity test instrument and appropriate accessories.
• Wet the filter with a suitable wetting fluid to ensure proper sealing and prevent air bypass.
• Connect the filter to the integrity test instrument using a sterile connector.
• Set the appropriate test parameters on the integrity test instrument, such as test pressure and test time.
• Initiate the integrity test, during which the instrument measures the pressure drop across the filter.
• Observe the pressure decay or bubble point test results to determine the filter's integrity.
• Compare the test results with established acceptance criteria to determine if the filter has passed or failed the integrity test.
• Document the test results, including the filter identification, test parameters, and outcome (pass/fail).
• If the filter fails the integrity test, investigate the cause of failure and take appropriate corrective actions.
• Repeat the integrity test after any corrective actions have been implemented to ensure the filter's integrity is restored.
Why we use 0.2 micron filters for aseptic process ? Can you please explain deeply.
Ok i will do this.
Because smallest size of particle is 0.3 micron and filter pore size is 0.2 micron..0.3 micron size particle can not be pass from 0.22 micron..
Perfectly answered 👍
Thank you sir