Basic Requirements for Steam Sterilizer Validation per ISO 17665 - ComplianceOnline (Basic Requirements)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

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).

Venue

Additional Information

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).