Sterilisation and sterile filtration are critical steps where a single failed cycle or filter can compromise a batch. GMP guidance, including EU GMP Annex 1, expects each cycle to be recorded with its parameters and indicator results, sterilising filters to be integrity tested, and failures to be investigated before product is released. Swat iQua Suite covers the Annex 1 controls for these records and connects them to the batch.
Cycles and indicators
Each cycle is recorded with its type, the steriliser or other equipment used, the load number, a parameter summary and, where relevant, the batch it served. Biological and chemical indicator results are entered against the cycle. QA release is a segregated duty — the operator cannot release their own cycle — and it is e-signed. The server refuses to release a cycle whose BI or CI failed, so a failed load cannot slip through on a busy shift.
Filter integrity tests
Sterilising-filter integrity tests are recorded by method — bubble point, diffusive flow or water intrusion — and as pre-use or post-use. Each test is verified by a second person with an e-signature. A failed test drives the sterile-impact process: a deviation is raised for investigation and a blocker is placed on the batch’s release dossier, so QA sees it before any release decision.
- Sterilisation cycles appear as a live count on the operations control tower.
- Release blockers flow into the batch release checklist automatically.
- Deviations raised by failures follow the normal investigation and CAPA route.