Determination of gamma radiation sterilization dose on bioceramic BCP-Sr-Ag as bone graft according to ISO 11137 standards

Background: BCP-Sr-Ag as a bone graft needs to be sterilized. One way of sterilization is to use gamma radiation. Sterilization by gamma radiation requires the correct sterilization dose. Based on ISO 11137 the determination of the sterilization dose through 3 steps: determination bioburden, determination of verification dose, and determination of sterilization dose. Purpose:Determination of gamma radiation sterilization dose on BCP-Sr-Ag bioceramic as bone graft based on ISO 11137 through determination bioburden, determination verification dose, and determination of sterilization dose. Method: A total 30 samples of 3 different batch BCP-Sr-Ag were determined for bioburden using TSA media. A total 100 samples of BCP-Sr-Ag were irradiated with a verification dose using cobalt-60 gamma source. The 100 samples then tested for sterilization using TSA media to determine the sterilization dose. Results: The average bioburden values of batches 1,2, and 3 were 56,8;61,8; and 60,5 CFU. The average value of the whole batch is 59,7 CFU. Based on ISO 11137, the verification dose is 7,4 kGy and the sterilization dose is 20,5 kGy. Conclusion: The average bioburden value of the entire batch was 59,7 CFU. The bioburden value used for verification dose determination is 64,22 CFU so the the gamma radiation sterilization dose is 20,5 kGy.