USP <382> Takes Effect: Raising the Bar for Elastomeric Components in Sterile Drug Packaging

By Christian Collazo-Sarra, Manager, CCIT, Medical Device, and Package Testing at Pace® Life Sciences

USP <382>, effective December 1, 2025, significantly changes how elastomeric components used in sterile drug packaging are evaluated. Instead of focusing on individual parts, the chapter requires assessment of the entire packaging and delivery system—including the drug product, elastomeric components, and associated devices—under real‑world conditions. A major emphasis is placed on container closure integrity, aligning expectations with deterministic testing methods such as vacuum decay, helium leak detection, and high‑voltage leak detection.

Beyond integrity, USP <382> expands functional suitability requirements to include factors like puncture performance, self‑sealing after multiple entries, retention forces, and usability‑related measurements such as plunger or cap removal forces. The chapter also shifts compliance responsibility to the holder of the regulatory filing, meaning drug sponsors must demonstrate that their specific packaging configuration performs as intended. These changes affect all stages of product development, encouraging earlier planning and more holistic evaluation of packaging systems to ensure safety, performance, and long‑term reliability.