Establishing the Sterilization Dose of Electron Beam for Sterilization of Medical Devices

Sterilized products are products in which no living microorganisms remain, and sterilization is to deactivate contaminated microorganisms and transform them into sterile products. The electron beam has the advantage of being easy to sterilize under the packaged state of the complete product, having a very short processing time, and not requiring separate treatment after sterilization or toxic substances. In the sterilization method using an electron beam accelerator, the sterilization dose determination and management are the main points of the quality management system. There are three methods for determining sterile doses: determining doses using bioburden information from Method 1, dose setting using molecular nucleus culture information from the incremental dose process to determine an extrapolation factor in Method 2, and determination of 25 kGy or 15 kGy of VDmax. In order to produce a complete sterilized product, the sterilization dose audit should be conducted at regular cycles in consideration of the degree of bioburden and packaging material of the product to be sterilized.