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Updated: Aug 25, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
[Study on Parametric Release of Ethylene Oxide Sterilization of Medical Devices]
Hongxin Huang1, Changming Hu1, Wenyi Liu2
1Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
Abstract:
This study briefly introduces the basic theory of sterilization, the characteristics of ethylene oxide sterilization for medical devices and the key factors about sterilization effectiveness, analyzes and compares three methods used in the product release of medical devices sterilized by ethylene oxide: test for sterility, traditional release and parametric release, and focuses on the theoretical basis, feasibility, validation requirements, advantages and disadvantages of parametric release.
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