PUPSIT

Pre-use post-sterilisation integrity testing of a sterilising-grade filter, expected by EU GMP Annex 1. The filter is integrity tested after it has been sterilised and installed, but before product is filtered, to detect damage from sterilisation or handling. Critics argue the extra connections add contamination risk downstream. Where PUPSIT is not feasible, the site must justify it with a risk assessment and other controls, and always test after use.