Sterisys Gmbh products

Comprehensive consulting: starting from the selection of a suitable sterilization process to the design of a turnkey system. Globally, approx. 60% of medical devices are sterilized with ethylene oxide. For this sterilization method, two processes are distinguished: the vacuum sterilization process and the overpressure sterilization process.  Thus, before purchasing a new system, you must first choose the right process which corresponds to your production process. We will gladly help you choose by analyzing your underlying conditions, such as device and packaging characteristics and production volume, and advise you accordingly. Additionally, sterilization tests can be performed with ethylene oxide and your product. Below you will find more information about both sterilization processes.

Preconditioning chamber: Preconditioning chambers ensure that the sterilization load reaches a homogeneous temperature and humidity, as required by ISO 11135:2014. This creates ideal prerequisite conditions for an effective sterilization process. Degassing chamber: After vacuum sterilization with ethylene oxide (EO), residual gas emissions are still on the devices. These post-conditioning chambers are used to achieve allowable EO residue value in the device. Air circulation and supply of fresh air in degassing chambers ensures that the gas residue value is reduced below the limit specified by ISO EN 10993-7. This process is carried out in accordance with EN 11135:2014.

Meet the requirements of the applicable standards through professional EO gas treatment. After sterilization with ethylene oxide (EO), gas may not be freely released into the atmosphere; therefore, a gas treatment unit needs to be interconnected. This allows you to professionally treat the generated amounts of EO in accordance with the requirements of the German TA-Luft guideline (EO <= 0.5 mg/m3). STERISYS offers different gas treatment units depending on the dimension of the system and the sterilization process: Electrical- or gas-operated catalyst, if necessary combined with a peak shaver (water buffer tank); scrubber system; gas combustion unit.