Industrial Sterilization for medical devices and pharmaceutical products
A wide range of medical devices and pharmaceutical products are sterilized by ethylene oxide exposure. Sterilization with ethylene oxide, also known as EO or EtO sterilization, is an established sterilization modality in this industry and provides clear advantages over other processes. Thanks to the low process temperature (below 55°C), the use of EO is far superior to other methods in terms of material compatibility – which means that it is ideally suited for the sterilization of thermolabile products.
However, due to the composition of ethylene oxide, a range of technical and regulatory requirements have to be fulfilled and taken into account. STERISYS is specialized in this domain and we develop and manufacture our equipment in accordance with all relevant standards and guidelines.
As a leading provider of ready-to-use ethylene oxide sterilization systems, we develop innovative and flexible solutions and deliver them to international medical device manufacturers and sterilization service providers.
Key benefits of our solutions:
- Safe and efficient sterilization of medical devices and pharmaceutical products;
- High degree of flexibility regarding cycle parameterization;
- Reliable reproducibility of the sterilization cycles;
- Long-term viability and conservation of value, thanks to state-of-the-art components and proven industry standards;
- Conformity with all relevant standards and guidelines (ATEX / EN1422:2014 /ISO 11135:2014 / FDA 21 CFR Part /GAMP 5);
- Manufacturing of customized sterilization units of all sizes, made to order in our factory in Belgium.