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    Radiation Sterilization – What is the ideal dose range specification for my product?

    Mike Steffgen
    February 12, 2020

    Methods for substantiation of the sterilization dose and establishment of the maximum sterilization dose.

    The use of high-energy ionizing radiation for sterilization purposes is an established and proven method for the inactivation of microorganisms on healthcare, food, and general industrial products. When following industry guidance there are various methods for substantiation of the sterilization dose and establishment of the maximum sterilization dose. What dose range is appropriate for the sterilization your product? What dose range will provide you with a quick, cost effective, and efficient processing turn time? This MDM West TechTheater presentation highlights the various options for setting minimum and maximum dose and how that translates into an efficient process. The selection of the proper dose range specification will help ensure a safe, reproducible, and capable process to consistently meet your needs.