Many single-use medical devices, such as tubing sets, masks and dressing sets, are made from plastics that cannot withstand high heat. Ethylene oxide (ETO) sterilisation is one of the most common methods for these products.
Why ETO is used
ETO is a gas that can reach every surface of a packed device, including inside tubing and through breathable packaging, at relatively low temperatures.
The three main steps
1. Preconditioning
Products are brought to the right temperature and humidity so the process works evenly.
2. Sterilisation
The chamber is exposed to ETO for a validated time, temperature and concentration.
3. Aeration
Residual gas is removed before products are released.
How sterility is confirmed
Each cycle is monitored and documented. Biological indicators and validated parameters are used to confirm that the process works as intended.
A sterile product is only as good as its packaging – integrity checks matter as much as the cycle itself.
Packaging matters too
Sterility only lasts as long as the packaging stays intact. That is why packaging integrity is checked before products leave the facility.
