Turnkey EtO Sterilization Solution
Worldwide preferred technology for sterilization of single use medical devices at low temperature is Ethylene Oxide (EtO). We optimise this sterilization process to offer fully turnkey solutions for medical devices manufacturers and sterilization services providers.
Our sterilization cycle is based on a vacuum cycle using preferably a mixture containing 100 % ETO or 90 % ETO + 10 % C02.
The process is controlled through three parameters:
- The Gas concentration
- The Temperature
- The Relative Humidity
All the components and functions of the sterilizer are controlled by a programmable logic controller (PLC) connected to a “human machine interface” HMI, or supervision computer. Our programs and supervision interfaces are fully documented and answer the 21 CFR Part 11 and GAMP requirements.