This gamma sterilization validation template provides guidance to personnel coordinating with the contract gamma sterilization in compliance with ISO 11137-1 and ISO 11137-2. This template covers VDMax25 and VDMax15 method for single as well as multiple batches.
This validation includes Performance Qualification (PQ). A typical PQ includes:
- Dose establishment and defining product family
- Confirmatory verification of dose experiment
- Periodic sterilization dose audit
This template is written specifically for early-stage medical device companies and are audit ready and are written by highly experienced professionals. Click below to get a preview of this template.
Price: $650
