V5 Ultimate
Manufacturing

PUPSIT

Pre-Use Post-Sterilization Integrity Test · pre-use post-sterilization integrity test

TL;DR

An Annex 1 expectation to integrity-test sterilising-grade filters after sterilisation but before use, to detect filter damage that could compromise aseptic processing.

PUPSIT requires that sterilising-grade filters used for aseptic filtration be integrity-tested after sterilisation but before product contact, so that any flaw introduced during sterilisation or installation is detected before the batch is at risk. Annex 1 (2022) reinforces this expectation; alternatives require a documented risk-based justification.

V5 binds PUPSIT results to the work-order step, the filter serial/lot, and the operator e-signature, so a missing or failed test blocks batch progression and is visible at QP release.

Regulatory anchors
  • EU GMP Annex 1 (2022)
Industries that live with this
PharmaceuticalBlood & Tissue
How V5 handles it
eBMR / eDHR — the batch record writes itself.
When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.
21 CFR Part 11 — the operating model, not a checkbox.
Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.
Related terms
Annex 1Media FillDeviationQP release
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