醫療設備製造中常見的氧化乙烷氧化物（EO）滅菌不合格
IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]
醫療設備製造中常見的氧化乙烷氧化物（EO）滅菌不合格 閱讀更多
July 2025
ETO滅菌重新資格
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
EO滅菌中的性能資格（PQ）-PPQ
Physical Performance Qualification (PPQ)• It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many
績效資格（PQ） - ETO滅菌中的MPQ
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic