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.


Your Approach to USP <382> for Your Drug Product Packaging: Think Systems, Not Components

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