Revised USP Chapter <382> Elastomeric Component Functional Suitability

The USP General Chapters Packaging and Distribution Expert Committee (PDEC) has revised the general chapter <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

Background

USP's needle and spike access functional suitability tests ( i.e., penetration force, needle self-sealing capacity, spike retention and sealability capacity) apply to packaging/delivery systems with closures that allow for drug product access by a hypodermic needle, spike, or other closure penetration devices. 

Comments received indicated that the Needle Self-Sealing Capacity test requirement to penetrate elastomeric closures 1.5 times needs to be revised. It was noted that this differs from ISO 11608-3, which specifies only 1.0 times penetrations. Applying the USP requirement could result in excessive punctures which may lead to leak test failures, even though such usage does not reflect typical patient behavior. To resolve this, USP has revised the requirement to specify 1.0 penetrations as the maximum number of scheduled punctures (i.e., "penetrate each closure 1.0 times the maximum number of scheduled penetrations").

The revised USP chapter <382> is official as of 1 February 2026. For more information please see USP's Revision Bulletins.