Presenter : Danielle DeLucy Duration : 75 Minutes


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Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation or continuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met.

Regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators will be provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Common questions and hot topics in industry will be presented to demonstrate the practical application of understanding steam sterilization. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving processes in an autoclave.

Areas Covered in the Session :

  • Steam sterilization on a microbial level
  • IQ/OQ/PQ Requirements for Autoclave Validation
  • Regulatory and GMP requirements for steam sterilization
  • Autoclave Monitoring Tests
  • Process verification tools for use in an autoclave
  • Biological Indicators – How and When to Use
  • Common questions, problems and cGMPs
  • Verification vs. Revalidation

Who Will Benefit:

  • Quality Assurance Departments
  • Validation Departments
  • Sterility Assurance Departments
  • Validation Departments

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