Glossary
Pre-use Post Sterilisation Integrity Test (PUPSIT)
An integrity test performed before use to confirm that a sterilised final filter assembly was not damaged during preparation and installation.
Details
PUPSIT looks for damage or loss of integrity after the filter has been sterilised and installed but before it is used, and so assures the starting condition of sterilising filtration. Inspections cite claims that it is not technically feasible unsupported by adequate risk assessment, alternative controls, or supply chain knowledge, and cases where the effect of the test on product quality was not verified. Check the filter assembly drawing, the risk assessment, the test raw data, the alternative controls, and the post-use test and investigation records.
