Ethylene Oxide (EtO or EO) Sterilisation, a low-temperature gaseous process, is the most popular form of sterilisation globally for single-use medical devices. EtO Sterilisation works by exposing products to EtO in a sealed chamber where the gas attacks, and ensures products are free from viable microorganisms.
Sterilising with EtO benefits from being highly efficient and is suitable for a wide range of medical devices, particularly instruments with long lumens and materials that are sensitive to heat and moisture. Medical devices frequently sterilised with ethylene oxide gas include:
Batteries must be removed from products before EtO Sterilisation and it cannot be used on liquids, sealed foil pouches, or glass bottles where Steam Sterilisation is preferable.
Andersen Caledonia is the largest independent supplier of Ethylene Oxide Sterilisation in the UK and Ireland with a capacity of over 10,000 pallets per year. All EtO Sterilisation is undertaken at our accredited Bellshill facility which conforms to ISO11135. Our dedicated facility has two 30m2 vacuum chambers controlled by a sophisticated software system – SCADA – that gathers data in real-time producing detailed cycle reports including load tracking. Over half of the cycles we run are mixed load cycles with multiple customer products allowing us the flexibility to accept variable load volumes and process small loads quickly. Our skilled Sterilisation Team runs a highly efficient warehouse supporting over 300 customers on a regular basis. Our customers range from established global device companies to start-up companies and the majority of NHS hospitals. We provide a comprehensive range of technical support from our dedicated Validation Team supporting customers that require regulatory approval in Europe, the United States, and globally. Our expertise in an extensive range of validations sets Andersen Caledonia apart from competitors, cutting both time and cost.
EtO gas is highly toxic and explosive; EtO Sterilisation at Andersen Caledonia follows strict procedures during processing:
Prior to sterilising via EtO, products are heated and humidified to improve the effectiveness of the process.
Before injecting the gas into the chamber the oxygen levels are reduced to prevent explosions. The load is then exposed to the gas for several hours to achieve a high level of sterility assurance.
Ensures all gas is removed from sterilised products using a combination of vacuums and heating.