Steam Sterilization Microbiology and Autoclave Performance Qualification

Why Should You Attend:

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. 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.

Learning Objectives:

• Steam sterilization on a microbial level
• Autoclave Performance Qualification expectations
• Regulatory and GMP requirements for steam sterilization
• Process verification tools for use in an autoclave
• Common questions, problems and cGMPs

Who Will Benefit:

The following professionals from all FDA regulated industries will benefit from this training:

• Quality Assurance
• Microbiologist
• Operations
• Production
• Validation

Instructor Profile:

Aaron Mertens has been a member of the STERIS Life Sciences Formulated Chemistries Technical Service Group as a Technical Service Specialist since January 2015. In this role, Aaron has responsibility for providing global technical support primarily for Critical Environments and Sterility Assurance and Barrier Products, application and validation.

Previously, for 7 years Aaron was the US Technical Manager for Atec Sterile Technology USA, a partner of Atec Pharmatechnik, Germany. For Atec USA, he was responsible for providing technical support for new and existing sterilization systems. This included project management, equipment commissioning, qualification, maintenance and troubleshooting. Also, while at Atec, Aaron managed the Commissioning and Qualification Program by maintaining standards, procedures and testing methods.

Prior to that, Aaron spent nearly 10 years at Pfizer in Kalamazoo, MI. At Pfizer, he specialized in sterilization validation of autoclaves, dry heat ovens / tunnels, freeze dryers and stopper processors. Additionally, he gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing validation programs for steam, dry heat, vapor phase hydrogen peroxide and irradiation sterilization processes.

Aaron has been a member of ISPE and PDA since 1999, contributing by presenting posters and talks at meetings, as well as participating in local chapter functions. He holds a bachelor’s degree in Genetics from the University of Wisconsin – Madison.

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