Whitepaper Radiation Sterilization
Sterility is essential for numerous medical devices such as implants, dressings and surgical materials in order to ensure safety and effectiveness in applications. But how exactly does radiation sterilization work and what steps are necessary for validation?
Validation of radiation sterilization
Validation is a complex process in the course of which proof is provided that the normative requirements for the manufacture of a medical device have been met. This process often poses numerous questions for manufacturers. In our white paper, we address the most important ones: We explain, among other things, how sterilization with beta (E-Beam) and gamma rays works, what advantages this method offers and also where its limitations lie. The white paper also covers the necessary validation steps in detail and explains what needs to be taken into account for secondary qualification for a second system or when switching from another sterilization method to sterilization with radiation.