USP General Chapter <665>: Separating Fact from Fiction

This presentation summarizes USP General Chapter <665>, which provides guidelines for qualifying plastic components and systems in pharmaceutical and biopharmaceutical manufacturing. It introduces a risk-based framework, starting with an initial suitability assessment and a matrix that classifies components as low, moderate, or high risk. Testing requirements—such as extraction solvents, temperature (40 °C), and duration—are tailored to each risk level to ensure science-driven practices.

The scope covers all drug products and biopharmaceuticals, excluding APIs for traditional small molecules and certain auxiliary items. The chapter emphasizes dynamic extraction conditions and standardized surface-area-to-solution ratios for consistency. While <665> is currently informational, it may become enforceable if referenced in USP notices or monographs. Alternative, scientifically justified methods are acceptable for compliance. The goal is to clarify regulatory expectations and support a flexible, risk-based approach.

Presented by Desmond G Hunt, Senior Principal Scientist at US Pharmacopeia

Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Sr. Principal Scientist in the Compendial Science Group-General Chapters. He works with the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms, and good storage and transportation practices. He participates in several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin.

Dr. Samuel Kikandi, Deputy Director- Principal Engineer at Sanofi

Dr. Samuel Kikandi is Deputy Director- Principal Engineer at Sanofi Inc., leading the Extractables and Leachables (E&L) and Material Science programs at Swiftwater/ Pennsylvania and Pearl River/New York, sites, USA. With 15+ years in the pharmaceutical industry, he serves as Subject Matter Expert for E&L qualifications of Single Use Systems (SUS) for product quality and patient safety. Dr. Kikandi provides end-to-end qualification strategies for SUS, covering risk assessment, study designs, data processing & reporting , and regulatory submissions to multiple health agencies around the globe. As a Co-Chair of Sanofi’s E&L Community of Practice Group and a key participant in industry forums, Dr. Kikandi actively shapes industry standards through multiple forums including the USP665, 661.1/662.2, ICH Q3E, Biophorum, and ELSIE. Dr. Kikandi holds a PhD in Chemistry from the State University of New York at Binghamton, New York, USA. He has published extensively in peer-reviewed journals and enjoys consulting on E&L widely.

Followed by a live Question and Answer Session