Free Guide · 4 pages
Sterility Testing Readiness Checklist
Eight questions to answer before your sterility testing program starts. For QA leads preparing for an ISO 11135 EO validation.
What's inside
- 8-item pre-validation checklist tied to ISO 11737-1, ISO 11135, and USP <71>
- Common 483-finding pitfalls and how to avoid them
- When method suitability has to be re-run (material changes, geometry changes)
- How Boulder BioLabs bundles method suitability with every sterility program
Written for QA leads preparing an EO sterilization validation.