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.
Understanding Validation for Verification Dose Maximum Sterilization
Published In: Medical Design Technology
March 11, 2016
BS, RM (NRCM), CQA (ASQ)
Senior Manager, Expert Advisory Services
Wendy Mach has over 27 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...