This Educational Session will provide an overview of microbiology principles in steam sterilization and application, as well as autoclave Performance Qualification, regulatory expectations and cGMPs. The presentation will highlight common questions and hot topics in industry to demonstrate the practical application of understanding steam sterilization.
The educational session will highlight
• 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
About the Presenter
Aaron Mertens is a member of the STERIS Life Sciences Contamination Control Solutions as a Technical Service Manager. For over 20 years, Aaron has held a number of positions within the Pharmaceutical Industry, specializing in cleaning, disinfection, sterilization and contamination control in parenteral drug manufacturing. In these roles, he has gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing quality assurance programs.
Aaron has been a member of various industry organizations (PDA, ISPE) since 1999, contributing by presenting posters and talks at meetings, as well as participating in local chapter functions. He is the current president of the ISPE Great Lakes Chapter. He holds a bachelor’s degree in Genetics from the University of Wisconsin - Madison.