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. This whitepaper provides guidance on performing sterilization dose audits to demonstrate the continued effectiveness of the established sterilization dose.
Readers will learn about the principles of SAL, the steps involved in performing a dose audit, and the importance of maintaining the effectiveness of the sterilization process. The whitepaper covers the different methods for establishing SAL and the factors that influence dose audits.
By understanding the principles of SAL and dose audits, 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 audit strategies, ultimately enhancing product quality and sterility assurance.