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Martell Winters (Director of Science, Nelson Labs)
Location: Insight Brief Theater
Date: Tuesday, April 30
Time: 12:30pm - 7:00pm
Track: Insight Briefing
Vault Recording: TBD
One aspect of sterility assurance, terminal sterilization, has been adapting in recent years to provide opportunities focused on optimizing sterilization processes, and/or reducing sterilization-induced product damage by rationalizing alternative sterility assurance levels (SALs). This presentation will provide concepts and options that are newer to the industry, including the revision of AAMI ST67 (selection of SALs), the new ISO 19930 (risk-based approach to an SAL other than 10-6), the new AAMI TIR76, and new ISO guidance regarding steam sterilization validation. The primary goal of this presentation is to assist manufacturers in understanding the options that are now available regarding minimizing the impact of sterilization on pharmaceutical products, in an attempt to facilitate use of terminal sterilization.