Wendy Mach has over 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. Wendy also spent four years as a lab supervisor, managing the sterility, microbial limits, bioburden, endotoxin, and antimicrobial effectiveness services. In 2004, Wendy moved to Salt Lake City to accept a position in the EO department at Nelson Labs 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 Health Care 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). Wendy’s participation on the domestic and international committees allows her to consult with clients to meet the regulatory standards of today – while preparing them to meet the demands of the future.