USP <382>: Think Systems, Not Components - Fragmentation, Plunger And Tip-Cap/Needle-Shield Functional Suitability Of Syringes And Cartridges

This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes, from a mechanical testing perspective.

United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems, which addressed characterizing for biological reactivity, physicochemical testing and functionality testing. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025 and will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. While under USP <381> compliance was typically a supplier responsibility, under the new chapter it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system, including the container closure system and the drug.