USP <665> Practice: Addressing Industry Questions On Single-Use System Compliance

This session brings together leading experts to address common industry questions surrounding USP <665> and its practical application in pharmaceutical and biopharmaceutical manufacturing. Participants receive platform guidance, instructions for submitting questions, and tips for ensuring smooth technical access before the discussion begins. The panel then walks through foundational concepts of USP <665>, including standard extraction conditions, risk‑based assessment, and determining when additional testing is required.

Speakers explain how to interpret extraction duration requirements, assess alternative risk‑assessment approaches, and determine whether existing data—such as BPOG‑based studies—can satisfy current expectations. The conversation also explores simulation studies, solvent selection, extractable–leachable correlations, and how to handle complex scenarios such as long contact times, resin testing, or highly variable process conditions.

Throughout the discussion, experts share regulatory insights, clarify misconceptions, and provide practical recommendations to help development teams navigate compliance, close data gaps, and strengthen their overall E&L strategy.