Do I need to perform a pre-use integrity test?

We recommend that users perform an integrity test both before and after use. Depending on regulatory and internal requirements, the pre-use test may be performed either pre or post sterilization.

For drug products made and sold in the United States, the FDA states that a pre-use integrity test can be performed, while a post-use test should be performed.1

For drug products sold or manufactured in the EU, the EU guide to GMP states that the integrity of the sterilized filter should be verified before use and should be confirmed immediately after use. 2

On condition that the regulatory requirements are followed, the decision to pre-use integrity test should be made by the end user based on risk assessment. Although all pharmaceutical grade filters are 100% integrity tested by Pall during manufacture, damage can occur during shipment or handling. A damaged filter that is used without detection because a pre-use integrity test was not performed could allow microbes or particulates to pass into the product. When the damaged filter is detected during the post-use test, the user would need to determine if it is possible to reprocess this fluid, or if it must be discarded.

Other Information/References:

1.    Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing: Good Manufacturing Practice

2.    Annex 1, Manufacture of Sterile Medicinal Products