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Wendy Mach and Jennifer Gygi

Co-author 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).

 

Jennifer Gygi

Co-author Jennifer Gygi has more than 25 years of medical device laboratory experience. She has worked in the Microbiology, Bioburden, IDs, and Packaging sections at Nelson Labs, working the last 15 years in the packaging group. As one of the original packaging group members at Nelson Labs, Gygi was heavily involved in validating all the packaging test methods and equipment and writing the test procedures for the packaging tests performed at Nelson Labs. She is a participating member on the ASTM F02 committee for packaging and is registered as a Specialist Microbiologist with ASM.

Articles

“How many packaging samples should I test?” For many medical device packaging professionals, this is a common question without an easy answer. Packaging test methods rarely contain sample size guidance, so it is left to the individual manufacturer to determine and...