Consulting Manager, Nelson Laboratories LLC
Wendy Mach RM (NRCM), CQA (ASQ), serves as consulting manager for Nelson Laboratories LLC, a Sotera Health company, which is a leading provider of microbiological testing and consulting services for MedTech companies. Mach has more than 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Mach also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin and antimicrobial effectiveness services. In 2004, Mach accepted a position in the EO department at Nelson Laboratories and was responsible for sterilization D-value and packaging microbial aerosol challenge studies. She is a participating member on the Technical Committee ISO/TC 198 Sterilization of Healthcare Products, the subcommittee chairperson for ASTM F02.15 Chemical / Safety Properties and a member of the Packaging and Distribution Expert Committee for United States Pharmacopeia (USP).
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