Determination Of Gamma Radiation Sterilization Dose on Bioceramic BCP-Sr-Ag as Bone Graft According to ISO 11137 Standards

Abstract

One type of bone graft being developed is alloplastic. The alloplastic that is used is Biphasic Calcium Phosphate (BCP). Bioactivity of BCP can be modified by adding ionic material as doping. Doping BCP with Strontium (Sr2+) and Silver (Ag+) becomes bioceramic which has better characteristics and degradability. BCP-Sr-Ag as a health product 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. The aim of this study is to determinate 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. This research was an in vitro laboratory. A total 30 samples of 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. The results of the research showed that 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. The verification dose of bioceramic BCP-Sr-Ag as bone graft is acceptable so that the gamma radiation sterilization dose can be determined according to ISO 11137. © (2023), (University of Dicle). All Rights Reserved.