Regulatory and QMS Technical File Templates

Gamma Sterilization
Validation Template

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ETO Validation Template

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:

  1. Dose establishment and defining product family
  2. Confirmatory verification of dose experiment
  3. 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