Ethylene Oxide (EO) is a chemical compound widely used in the low-temperature sterilization process of single-use medical devices.
By using a vacuum sterilization process, ethylene oxide can effectively penetrate the surfaces of most devices. The low temperature makes it an ideal process for a wide range of materials.
EO effectively disrupts cellular metabolism and the processes of multiplication of microorganisms.
Penetrates permeable packaging systems and acts on all available surfaces of the product to achieve required Sterility Assurance Level (SAL).
Advantages of sterilization with Ethylene Oxide
EO sterilized materials are not exposed to high temperature, moisture, or radiation.
Many different materials can be sterilized with EO, particularly polymeric components commonly used in medical devices.
Products can be sterilized as they are finally packed, because EO penetrates through packaging systems and cartons.
High efficiency at low process cost compared to other sterilization methods.
We use state of the art sterilization chambers equipped with metrologically supervised measuring systems.
The sterilization process is fully controlled, controlled and archived by a validated computer system.
We use state of the art sterilization chambers equipped with metrologically supervised measuring systems.
We have several modern production lines for sterilization on an industrial scale.
Each line has separate chambers responsible for:
Conditioning
The sterilization process is preceded by a stage of preliminary conditioning, during which the spores of microorganisms are activated. The process is carried out at the controlled temperature and humidity.
Sterilization
Products transported from the preconditioning stage are treated with Ethylene Oxide under controlled conditions to achieve an appropriate SAL (Sterility Assurance Level).
Desorption
Immediately after sterilization, the products are ventilated in dedicated cells to remove EO residues. At the end of this stage, the products remain in our warehouse in controlled conditions.