Basic Requirements for Steam Sterilizer Validation per ISO 17665

This Steam Sterilization training 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). For decades, steam sterilization (autoclaving) has been an integral part in the manufacturing and laboratory processes in the medical device, pharmaceutical, and HCT/P industries.

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