医療機器の製造における一般的なエチレン酸化物（EO）滅菌非変性
IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […】
医療機器の製造における一般的なエチレン酸化物（EO）滅菌非変性 続きを読む
July 2025
ETO滅菌の再資格
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
パフォーマンス資格（PQ）-PPQ EO滅菌
Physical Performance Qualification (PPQ)• It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many
パフォーマンス資格（PQ）-ETO滅菌におけるMPQ
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic
パフォーマンス資格（PQ）-ETO滅菌におけるMPQ 続きを読む