Module 14: Design Development and Certification of Medical Devices

17/11/2023

ETHYLENE OXIDE STERILISATION

Five stages 1. evacuation with humidification, 2. gas introduction, 3. exposure, 4. evacuation, and 5. air washes

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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• takes several hours, …excluding aeration time (removal of ETO). ETHYLENE OXIDE STERILISATION

• Mechanical aeration takes 8 to 12 hours at +50 to +60°C;

• passive aeration is also possible, but can take 7 days.

• After the aeration is complete, the sterilised objects are removed (batch processing). ETO chemically reacts with amino acids, proteins, and DNA to prevent microbial reproduction

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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