Module 14 2022

22/03/2022

ETHYLENE OXIDE STERILISATION

• takes several hours, excluding aeration time (removal of ETO). • 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

21

ETHYLENE OXIDE STERILISATION

SUITABLE FOR: – Items that cannot be sterilised at high temperature, pressure – Due to its low +30° to +60°C temperature conditions, ETO sterilisation is well suited for medical devices with embedded electronics. – However, the vacuum may not be acceptable for embedded batteries – Also suitable for dressings etc.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

22

11