USP <665> Becomes Official On May 1, 2026. Are You Ready?

The United States Pharmacopeia (USP) Chapter <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products provides crucial guidance on the analytical testing of SUS to mitigate the risks associated with extractables and leachables (E&L). Chemical characterization and qualification of plastic components used in pharmaceutical manufacturing are no longer optional considerations — they are now becoming regulatory expectations. With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.

Our white paper outlines a structured, science-based approach to:

• Systematically assess E&L risks from single-use systems
• Design compliant testing strategies aligned with USP <665>
• Build a robust documentation framework
• Prepare your organization for a smooth and timely transition

Download the white paper and start preparing for USP <665> with confidence.