Performance Process Qualification (PPQ)

Performance Process Qualification (PPQ)

Performance Process Qualification demonstrates that the validated sterilisation cycle reliably delivers the required sterility-assurance level for a defined product load under routine operating conditions.

We execute fractional, half-cycle and full-cycle runs, biological-indicator placement, and residual-EO/ECH verification per ISO 11135 — producing the qualification report needed for product release and regulatory submission.