Sterility Assurance Program using Radiation Sterilization for Medical Devices
When the medical device manufacturers produce sterilized product using radiation method, how can they ensure the sterilize process and is being completed?
ANSI/AAMI/ISO 11137-2: 2006 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose is a common method for validation of the radiation dose used to sterile a medical device. The method used to determine product bioburden enumeration and a bioburden organism resistance sterility test is referred to the verification dose resistance experiment. The most appropriate methodology is selected based on the projected production schedule and size, as well as the expected bioburden levels of the product
Below please find the summarized steps of our services for initial validation of sterilization:
Once the initial validation is successfully completed, the program is required to perform in a quarterly basis to ensure the validity of sterilization dose.
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