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 1. Home
 2. Courses
 3. Steam Sterilization Microbiology and Autoclave Performance Qualification


STEAM STERILIZATION MICROBIOLOGY AND AUTOCLAVE PERFORMANCE QUALIFICATION

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Sorry, registration has ended.

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Faculty: Danielle DeLucy

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 * Date: 08-04-2021 01:00 PM - 08-04-2021 02:15 PM
 * Location: Online Event

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DESCRIPTION

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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