Sterilizer for the pharmaceutical industry

ethylene oxidefloor-standingwith vacuum cycle

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. EO vacuum sterilization systems, among others, are offered by sterilization service providers, as this process is particularly well suited for medium to large production volumes. Medical devices are generally sterilized in their tertiary packaging on pallets. The latter are positioned in one or two rows in the chamber, oriented lengthwise or crosswise, depending on the customer and space requirements. STERISYS defines the exact chamber size together with you based on your production volume. According to the current state of the art, the vacuum sterilization process consists of three phases: Preconditioning: preparation of medical devices for the sterilization process Sterilization: sterilization of devices in negative pressure Degassing: elimination of residual gas in the device according to EN ISO 10993-7 Standard EO gas concentrations for the EO vacuum sterilization process: 100% EO gas, packed in drums; 90% EO – 10% CO2. As these EO concentrations are so high, the sterilization system must be designed and manufactured in accordance with the ATEX guidelines.