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PUBLISHED ARTICLE

Understanding Validation for Verification Dose Maximum Sterilization

Published In: Medical Design Technology

Lower sterilization doses are now available with the VDmax method of validation and may be used as a viable alternative to providing assurance of sterility without using the large sample sizes required by other methods.

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Wendy Mach

Wendy Mach

RM (NRCM), CQA (ASQ)
Packaging Expert

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...