EO sterilisation: planning for future regulatory change

Published: 11-May-2015

Exposure to ethylene oxide (EO) gas is a popular method of sterilisation for medical devices. However, manufacturers need to be aware of and addresss new standards and regulatory changes to ensure future compliance. Susan Birks reports

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First used in the 1940s, ethylene oxide (EO) is an alkaline gas that can infiltrate packaged medical devices and kill micro-organisms to achieve sterilisation. It is suited to the majority of heat-, moisture- or radiation-sensitive medical products. Because of EO’s reactive nature, the sterilisation process is carried out in enclosed chambers to prevent leaks and exposure to the gas.

It is a slightly lengthier process than other methods, involving three stages:

  1. Preconditioning and/or conditioning of device through temperature and humidity variations
  2. The gas dwell phase/sterilising cycle where the device is exposed to the EO gas
  3. Aeration of the device for removal of gas from the product.

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