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”. When SAL is established using Method 1, Method 2 or Method VDmax, a periodic sterilization dose audit is required by ANSI/AAMI/ISO 11137-1. The purpose of such audits is to demonstrate the continued effectiveness of the established sterilization dose. By reading this Whitepaper, Quality Assurance, Sterility Assurance and Validation personnel will learn how to perform the sterilization dose audits.
