SteriComp GmbH

medical devices

About

We are a German consulting company specialized in sterilization of medical devices with a core team and further freelance sterilization experts who work in close consultation with us for your individual requirements. Our customers are medical device manufacturers worldwide who want to maintain or improve fulfillment of the regulatory compliance and efficiency of their sterilization processes and who need skilled staff and expertise for time-critical projects or also for permanent outsourcing. Our main fields of expertise are: Sterilization validations for ethylene oxide- (ISO 11135) and radiation sterilization (ISO 11137). EO gas residual studies (ISO 10993-7 incl. AMD1 for new-borns and children). Reprocessing (FDA guidance and ISO 17664). Development and validation of sterile barrier systems for terminally sterilized medical devices (ISO 11607). Quality management processes related to sterilization. Plant construction, maintenance and optimization of EO sterilization systems. Contact us with a project enquiry or for a free 30 min consulting session.

Technologies

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Keywords

microbiology ethylene oxide sterilization reprocessing radiation sterilization operation of sterilization plants clean room iso 109937 iso 116072 iso 11137 quality management bioburden iso 116071 sterilization plant engineering medical devices sterile barrier systems iso 11135 bioburden testing sterilization validation environmental monitoring regulatory compliance sterilization process development validation of sterile barrier systems reprocessing guidance mdr sterile barrier integrity iso 16775 manufacturing parametric release validation reports

Location

Am Pfannenstiel, Nattheim, Baden-Wuerttemberg, Germany, 89564

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