They could be associated to other equipment as:
•Pre-Conditioning room : to warm and reach good humidity set point inside the product before sterilization cycle to save production time
•Degassing room : to remove residual EtO from the sterilized products
•Gas treatments : to catch and neutralize the rejected gas pollutants
•Conveyors : to simplify and ensure homogenous cycles
•Tracking system : to perform in production quality system
•Supervision : to report and manage online all kind of actions
Performing a high level of qualifications and associated with a good preventive maintenance program, these equipments are efficient, repeatable and reliable.
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.
Worldwide preferred technology for sterilization of single use medical devices at low temperature is Ethylene Oxide (EtO). This sterilization process is optimized by MDS to offer fully turnkey solutions for medical devices manufacturers and sterilization services providers.
Turnkey EtO Sterilization Solution