USP General Chapter 382: Health Inspired, Quality Driven

A new regulatory chapter introduces comprehensive expectations for evaluating elastomeric components used in parenteral product packaging and delivery systems. Its purpose is to ensure these components maintain product integrity, support proper administration, and prevent contamination throughout the full product lifecycle. The chapter expands upon previous standards by moving beyond isolated component testing and requiring system‑level evaluations that reflect real‑world use.

The scope includes vials, syringes, cartridges, injectors, blow‑fill‑seal containers, and infusion systems that incorporate elastomeric closures, plungers, seals, or access points. Manufacturers must now demonstrate performance across several functional domains, including integrity, access, retention, plunger movement, and sealing behavior. Integrity assessments reference modern deterministic leak‑testing principles, while access evaluations cover penetration forces, self‑sealing after repeated punctures, and spike retention. Additional requirements address plunger break‑loose and extrusion forces, seal tightness under pressure, and removal forces for tip caps and needle shields.

Acceptance criteria are provided for many tests; where not specified, scientific justification is required. Compliance depends on validated methods, realistic sample preparation, and thorough documentation. These updates reinforce the shift toward holistic, system‑specific testing and emphasize ongoing lifecycle management as packaging materials, formulations, or processes evolve.