IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]
Bežné nekonzomaty etylénexidu (EO) vo výrobe zdravotníckych pomôcok Prečítajte si viac
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
Rekvalifikácia sterilizácie ETO Prečítajte si viac
Physical Performance Qualification (PPQ)• It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many
Výkonnosť kvalifikácie (PQ) -PPQ pri sterilizácii EO Prečítajte si viac
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic
Kvalifikácia výkonnosti (PQ)- MPQ v sterilizácii ETO Prečítajte si viac