Module 14 2022

22/03/2022

CHEMICAL - STERILISING GASES

ETHYLENE OXIDE (ETO) [ISO 11135: 2014 / A1: 2019] – Does not involve high temperatures / high humidity – Slower than STEAM – due to aeration stage: can range from hours to days

– Inherently hazardous! – Flammable – Carcinogenic - residues

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

19

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

20

10