Filter integrity test

A non-destructive test, such as bubble point, diffusion or pressure hold, or water intrusion for hydrophobic vent filters, that shows a sterilizing or other critical filter is intact and will retain bacteria as validated. Tests are run after use and, where required, before use after sterilization (pre-use post-sterilization integrity testing, PUPSIT). EU GMP Annex 1 expects PUPSIT unless a risk assessment justifies leaving it out. Japanese batch records record the test result and filter lot, and a failed post-use test must be investigated before the batch can be released.