Vent filter/ Air filter validation studies

Quality Assurance
1

Dear All,

What are the basic FDA requirements with respect to vent filters/ Air filters used in C and B area .

  1. Vent filters for Storage vessel/ preparation vessel
    2.Filters used in Disinfectant filteration.
    3.Air filters used in (ozaf) eyedrops bottle filling machine.

In addition to this vent filters & air filters in P.W.S, and Other pharma equipments.
Support with guideline, what are the studies required and frequencies for replacement…

Thanks

2

Ok, vent filters used in Autoclave operations ,filter integrity test bubble point shall be performed.
After confirmation of integrity of filter can be used on vacuum breake.
Frequency for microbiology is monthly basis
Frequency for production Support daily
For disinfectant filtration system daily
Replacement of filters as per manufacturers recommended 100 sterilization cycle.
Means a filter is capable to strile 100 times.

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3
  1. Vent filter for storage vessel-Perform pre and post integrity of filter for each batch manufacturing.
  2. Disinfectant filter-Perform preintegrity - sterilize the filter-use for filtration-post integrity of filter.
  3. Air filter on filling machine-Perform pre integrity-sterilize the filter- use in filling-post integrity of filter.
    Filter should be replaced in case of filter integrity fail and it should be replaced after recommended sterilization cycle of filter as mentioned in COA of filter.
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4

Thank you.

5

Thanks.

If i can perform integrity test for multiple filters using a standalone integrity tester,? let Pall or Millipore.
provided i should have desired housing and operating parameters specification!!?
How do you maintain the records for usage…
Thanks.

6

Check the minimum bubble point or flow rate of filter on filter certificate and perform integrity.
Following data should be recorded in log book.
1.date of integrity
2.mention pre or post integrity
3.filter lot no.
4.filter serial number
5.test pressure
6.observed value
7.result pass or fail
8.done by
9.checked by
10.uses of filter
11.product name
12.batch number

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7

You should also maintain filter replacement record ,filter cleaning and sterilization record.

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