USP <382> Revision: Updated Requirements for Elastomeric Closure Testing

The United States Pharmacopeia Packaging and Distribution Expert Committee (PDEC) has revised General Chapter USP <382> Elastomeric Component Functional Suitability, addressing functional testing of elastomeric closures used in parenteral packaging and delivery systems.

The chapter includes tests such as penetration force, needle self-sealing capacity, spike retention, and seal integrity for systems accessed via needles or spikes. Based on stakeholder feedback, USP updated the requirement for the needle self-sealing capacity test.

Previously, closures were required to be punctured 1.5 times the maximum number of intended uses. However, this exceeded typical clinical practice and differed from ISO 11608-3, which specifies 1.0 penetration. Excessive puncturing could also increase the risk of leakage during testing.

To address this, USP now limits testing to 1.0 times the maximum number of scheduled penetrations. The revised chapter became official on 1 February 2026.

16-03-2026