IntroductionEthylene Oxide (EO) sterilization remains a preferred method for medical devices incompatible with radiation or moist heat. However, it’s a […]
אי-התאמות של תחמוצת אתילן נפוצה (EO) אי-התאמות בייצור מכשירים רפואיים קרא עוד
ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency • Minimum annual requirement• At least once per year, verification data, subsequent re-validation data,
Physical Performance Qualification (PPQ)• It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many
הסמכת ביצועים (PQ) -PPQ בעיקור EO קרא עוד
Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic
הסמכת ביצועים (PQ)- MPQ בעיקור ETO קרא עוד