IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]]
Oxyde d'éthylène commun (EO) Non-conformités dans la fabrication de dispositifs médicaux Read more
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 Read more
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 Read more
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 Read more