This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.
Gamma radiation processing is used as a product sterilization method for enormous volumes of finished medical devices and other surgical, clinical, and diagnostic products. The most common method employed to validate or qualify the process for devices has historically been Method 1, and in more recent years the alternate VDmax method has also become very popular. Both methods employ product bioburdens testing followed by analysis with sub lethal radiation exposures. This presentation will review the general requirements for validation as described in ISO 11137:2006.
Areas Covered in the seminar:
- General requirements of ISO 11137:2006, Method 1 and VDmax25, to include (but not limited to):
- Pre-validation activities and requirements.
- Product bioburden testing and analysis.
- Laboratory methods and practices.
- Analysis of verification dose results.
- Basics components of protocol and final report.
Who Will Benefit:
- Validation engineers cross-training into ISO sterilizer validations
- Laboratory staff involved with validation activities
- Quality or Regulatory staff now being assigned sterilizer validation responsibilities
- Supervisors of Manufacturing or Laboratory Departments responsible for sterilization processes
- Auditors responsible for reviewing contract sterilizer documents or quarterly dose audit records
