Understanding And Implementing USP <665> For Single-Use Systems

Single-use systems have transformed pharmaceutical and biopharmaceutical manufacturing, but they also introduce new expectations for chemical safety and regulatory rigor. USP <665> establishes a clear, risk-based framework for evaluating extractables and leachables from plastic components that contact process streams, drug substances, and finished products. With mandatory compliance effective May 1, 2026, manufacturers must move beyond ad hoc testing toward structured material characterization, process mapping, and targeted analytical strategies.

This paper clarifies the scope of USP <665>, outlining which components are covered, how standardized extraction protocols are applied, and why “representative use” conditions matter more than theoretical worst cases. It also walks through practical risk assessment steps — from component identification through risk control—showing how scientific judgment and process knowledge guide efficient testing decisions. Clear preparation guidance helps teams build defensible testing plans, select qualified laboratories, and maintain documentation that stands up to regulatory scrutiny.

For organizations relying on single-use technologies, this is a timely resource to reduce uncertainty, avoid last‑minute disruptions, and strengthen product quality as the USP deadline approaches. Read the full paper to deepen your understanding of USP <665> compliance and implementation.