Your Approach To USP <382> For Your Drug Product Packaging


The United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The scope of USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems1 introduces a paradigm shift away from testing elastomeric components individually by the supplier, as was done historically under USP <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems,2 to a holistic evaluation of these components when assembled into drug product packaging and delivery systems. In addition, the testing is performed on the final product-package configuration as produced by the drug product manufacturer, using product-filled systems or systems filled with a suitable proxy, where applicable.

This article focuses on vial, syringe and cartridge container closure systems.

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West Pharmaceutical Services, Inc.