Basic Requirements for Steam Sterilizer Validation per ISO 17665

Sterilization is designated as a “special” validation process by both FDA and ISO, having unique requirements. FDA inspectors are instructed to review sterilizer validations at each company that employs sterilization processes. This presentation will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134).

Areas Covered in the seminar:

• General requirements of ISO 17665 (overkill method, formerly ISO 11134).
• Items to be included in the validation protocol.
• Equipment, materials, monitoring devices used during validation.
• Activities performed during the execution of the study.
• Items to be included in the final report.
• Training issues.

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 audit responsibilities
• Supervisors of Manufacturing or Laboratory Departments responsible for sterilization processes
• Auditors responsible for reviewing contract sterilizer documents
• Hospital Central Services staff that may have need for knowledge of FDA sterilizer validation requirements

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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