In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as required by regulatory authorities to designate the treated product as “sterile.” There are several approaches—the sterilization dose setting methods 1 and 2 and the substantiation method VDmax SD—that may be used to establish the minimum dose that results in the required degree of sterility assurance. This whitepaper provides guidance on the different aspects of each method that have to be considered in order to make the best decision for a specific product.
Readers will learn about the principles of SAL, the different methods for setting the sterilization dose, and the factors that influence the choice of method. The whitepaper covers practical examples and case studies to illustrate key concepts, offering insights into best practices for setting the sterilization dose.
By understanding the principles of SAL and dose setting methods, professionals involved in sterilization, quality assurance, and regulatory compliance can optimize their sterilization protocols. This knowledge will help them ensure that their products are safe, effective, and compliant with regulatory standards. The whitepaper provides practical guidance on implementing effective dose setting strategies, ultimately enhancing product quality and sterility assurance.