IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]
I-Ethylene Oxide (EO) inzalo engahambelani ekwakhiweni kwensiza yezokwelapha Funda kabanzi
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
I-ETO Sterilization Real Funda kabanzi
Physical Performance Qualification (PPQ)• It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many
Ukusebenza Kwemfanelo (PQ) -PPQ ekusetshenzisweni kwe-EO Funda kabanzi
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic
Ukusebenza Kwemfanelo (PQ) - I-MPQ ekusetshenzisweni kwe-ETO Funda kabanzi