Pharmaceutical Sterility Assurance: Concepts and Options for Terminal Sterilization | CPhI North America

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Pharmaceutical Sterility Assurance: Concepts and Options for Terminal Sterilization

Martell Winters (Director of Science, Nelson Labs)

Location: Insight Brief Theater

Date: Tuesday, April 30

Time: 12:30pm - 1:15pm

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.