Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137

Why Should You Attend:

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

Instructor Profile:

Mark Dott, has over 20 years industry experience, covering a wide range of medical devices, permanent implants, surgical disposables, pharmaceuticals, biological, biotech, and human tissue products. He has validated or supervised sterilization processes for gamma, ETO, and steam sterilization per AAMI and ISO guidelines, and has validated USP/AAMI microbiology test methods for use in medical device GMP laboratories. He is also skilled in cleaning-resterilization process validations for reusable medical instruments, kits, & sets, and disinfectant validations for Cleanrooms.

Projects commonly include preparation of validation test protocols, execution of the validation studies, review and approval of data to insure compliance with published guidelines, preparation of final report(s), and training of client’s employees. Clients include numerous device companies, contract laboratories, and tissue banks. Mr. Dott received a M.S. degree in Microbiology in 1983, is a member of AAMI and ASM, and has been providing consulting services since 2002.

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