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FILTER INTEGRITY
TESTING
&
Associated Risks
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INTEGRITY TESTING

Before autoclave Before filtration

Cleaning of filter housing & filter cartridge

Cleaning of filter housing & filter
cartridge

Assembly of filter housing & filter

Assembly of filter housing & filter
cartridge
cartridge

Autoclaving
Liquid flushing & integrity testing

Set up, liquid flushing & integrity

testing in filtration room
Autoclaving

Filtration & post filtration integrity

testing
Filtration & post filtration integrity testing
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Associated Risks

Testing Before Autoclave

 Can’t detect leakage at the early stage prior to the filtration.

 Not suitable for suspension products as they can’t be re-filtered (when

suspension is formed after aseptic filtration).

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Testing Before Filtration

 Additional aseptic manipulations

 May increase bioburden on the filter surface from integrity testing

compressed air

 Water spillage in the filtration area (B grade)

 Addition of the flushing liquid in the formulation

 Not suitable for products which are incompatible with the flushing liquid..
e.g. oil/alcohol based products

 Not suitable for ready to use filter.e.g for mAb products

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REGULATORY OVERVIEW

The integrity of the sterilized filter should be verified before use and

should be confirmed immediately after use.

MHRA/EU/WHO
The integrity of critical gas and air vent filters should be confirmed

after use.

The integrity of other filters should be confirmed at appropriate

intervals.

Integrity testing of the filter(s) can be performed prior to processing,

FDA
and should be routinely performed post-use.

The validated physical integrity test of a sterilizing filter shall be

ISO
conducted after each use without disturbing the filter in its housing.

Physical integrity testing of a sterilizing filter in situ should be

conducted before use after sterilization where the design of the

filtration system permits.

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THANK YOU………………..