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. By reading this Whitepaper, Quality Assurance, Sterility Assurance and other interested professionals will learn about the different aspects of each method that have to be considered in order to make the best decision for a specific product.
