This workshop will provide an overview of microbiology principles in steam sterilization and application, as well as autoclave Performance Qualification, regulatory expectations and cGMPs:
- Steam sterilization on a microbial level
- Autoclave Performance Qualification expectations
- Regulatory and GMP requirementsfor steam sterilization
- Process verification tools for use in an autoclave
Since 2015, Aaron has responsibility for providing global technical support primarily for Critical Environments (i.e. environmental sanitizers, disinfectants, sporicides), Sterility Assurance Products (i.e. biological and chemical indicators), and Barrier Products Solutions (i.e. sterilization wrapping), application and validation.
For over 20 years, specializing in cleaning, disinfection, sterilization and contamination control in parenteral drug manufacturing, Aaron has gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing quality assurance programs. Aaron is a member of various industry organizations (PDA, ISPE) since 1999, presenting posters and talks and is the current president of the ISPE Great Lakes Chapter. He holds a bachelor’s degree in Genetics from the University of Wisconsin – Madison.