Medical devices are subject to a range of specific safety and compatibility requirements. Sterility is a fundamental requirement in ensuring that the devices are free from germs and can be employed without any concern.
As medical devices are frequently produced from a combination of different materials, sometimes feature very complex structures and often cannot be exposed to the high temperatures applied in steam sterilisation or the irradiation associated with radiation sterilisation, sterilisation with ethylene oxide (EO) is the method of choice when it comes to the sterilisation of medical devices.
Sterilisation with ethylene oxide (EO)
This tried-and-tested sterilisation method employed all over the world is nowadays highly standardized and, as a technically sophisticated method, represents a reliable option for sterilising materials without the risk of inflicting any damage. Unlike other techniques, EO sterilises efficiently even at low temperatures and is thus particularly suitable for use on plastics.
During the process, the EO gas infiltrates both the packaging and the device itself, destroying any and all viable microorganisms. There are four parameters which are decisive for the success of the sterilisation process and these need to be coordinated precisely for each device:
- Gas concentration
- Temperature
- Relative humidity
- Exposure period
Advantages of the process:
- Gentle and effective sterilisation of materials at low temperatures – This guarantees the integrity of the product and packaging
- Material compatibility – This procedure can be used to sterilise a wide range of materials and material combinations