Oxyde d'éthylène commun (EO) Non-conformités dans la fabrication de dispositifs médicaux
IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]]
July 2025
Re-quanfication de la stérilisation de l'ETO
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
Re-quanfication de la stérilisation de l'ETO En savoir plus
Performance Qualification (PQ) -PPQ dans la stérilisation EO
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 dans la stérilisation EO En savoir plus
Qualification de performance (PQ) - MPQ dans la stérilisation ETO
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic
Qualification de performance (PQ) - MPQ dans la stérilisation ETO En savoir plus