This Sterilization Validation Procedure complies with ISO 11137, ISO 13004, ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for validating Gamma irradiation sterilization processes to ensure sterility assurance and regulatory compliance. Digital delivery within 24 business hours.
This procedure outlines validation activities for Gamma irradiation sterilization, including dose mapping, bioburden testing, verification dose experiments, routine monitoring, and requalification. It defines acceptance criteria, documentation requirements, and responsibilities for maintaining validated sterilization processes. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.