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Review of surface steam sterilization for validation purposes

  • Joost van Doornmalen
    Affiliations
    Department of Validation and Monitoring, Bureau Veritas, Amersfoort, The Netherlands

    Department of Applied Physics, Eindhoven University of Technology, Eindhoven, The Netherlands
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  • Klaas Kopinga
    Correspondence
    Address correspondence to Klaas Kopinga, PhD, Department of Applied Physics, Eindhoven University of Technology, P.O. Box 513, 5600 MB Eindhoven, The Netherlands.
    Affiliations
    Department of Applied Physics, Eindhoven University of Technology, Eindhoven, The Netherlands
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Published:January 21, 2008DOI:https://doi.org/10.1016/j.ajic.2007.02.002
      Sterilization is an essential step in the process of producing sterile medical devices. To guarantee sterility, the process of sterilization must be validated. Because there is no direct way to measure sterility, the techniques applied to validate the sterilization process are based on statistical principles. Steam sterilization is the most frequently applied sterilization method worldwide and can be validated either by indicators (chemical or biological) or physical measurements. The steam sterilization conditions are described in the literature. Starting from these conditions, criteria for the validation of steam sterilization are derived and can be described in terms of physical parameters. Physical validation of steam sterilization appears to be an adequate and efficient validation method that could be considered as an alternative for indicator validation. Moreover, physical validation can be used for effective troubleshooting in steam sterilizing processes.
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