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 Systemsi 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 Systemsii, 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 packaging/delivery system as produced by the drug manufacturer, using product-filled systems or systems filled with a suitable proxy, where applicable. As such, the elastomeric component supplier cannot perform USP <382> testing without knowledge of the specific drug product/proxy or the complete packaging system that the drug manufacturer plans to use. Therefore, the responsibility for USP <382> testing shifts from the elastomeric component supplier to the drug manufacturer.
Jen Roark, Lauren Orme and Mike Ulman
September 03, 2024