IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]
Common Ethylene Oxide (EO) Sterilization Non-Conformities in Medical Device Manufacturing 閱讀更多
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
ETO Sterilization Re-qualification 閱讀更多
Physical Performance Qualification (PPQ)• It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many
Performance Qualification(pq)-ppq in eo sterilization 閱讀更多
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic
Performance Qualification (PQ)- mpq in eto sterilization 閱讀更多