Worldwide preferred technology for low temperature sterilization of single use medical devices is Ethylen Oxide (EtO). This sterilization process is optimized by MDS to offer fully turnkey solution for medical device manufacturers and sterilization services providers.
Our sterilization cycle is based on a vacuum cycle using preferably pure ETO and Nitrogen in order to have a non flammable mixture during cycles.
The process is controlled through four parameters: - Gas concentration - Temperature - Relative humidity - Exposure time.
Performing a high level of qualification and associated with a good preventive maintenance program, these equipment are efficient, repeatable and reliable.
EtO sterilizers can be associated to other equipment such as:
- Preconditioning cell : To warm and reach good humidity set point inside the product before sterilization cycle to save production time
- Desorption cell : To remove EtO residual from the sterilized products
- Conveyors system : To increase efficiency and process optimization
- Tracking system : To perform in production quality system
Our system is including one stainless steel catalytic burner with peak shaving system. This system is the most efficient one.
The peak shaver aim is to control the EtO concentration to be treated by the catalytic burner. When a large quantity of EtO is coming (from the sterilizer during the rising steps), EtO is stored in the water. Then the water circulation through a column send to the air flow a controlled concentration of EtO to the catalytic burner.
The catalytic burner include an electrical heater and a powerful heat exchanger to heat the air flow (200°C) before the catalytic bed to allow the reaction of EtO converted into CO2 and vaporized water. Because the reaction is exothermic, the outlet flow is used to preheat the inlet flow thanks to the heat exchanger.
The Scrubber aim is to solubilize ETO gas into an acid washer. A reactor and a washing tower allow the ETO transformation to Ethylene glycol thanks to perfect condition of temperature and acidity.
The washing tower is here to allow gases to be in contact with water to be absorbed. A water pump push water from the reactor to the top of the tower. EtO comes from the bottom of the tower to the top. Contact time is an important factor of efficiency.
The chemical reactor, placed under the washing column, is there to allow the chemical reaction and store Ethylene glycol created.
Catalitic Burner :
In order to achieve the sterilization cycles and process parameters MDS builds standard or custom made cycles, including various sequences . Each sequence can be time or parameter driven and in any case the transition can only be allowed if the previous one has been achieved successfully.
Our programs and supervision interfaces are fully documented and answer the 21CFR Part 11 and GAMP requirements.