TR 2022/258: Think Systems USP 382 - Fragmentation

USP <381> Elastomeric Components in Injectable Pharmaceutical Product Packaging / Delivery Systems has traditionally been used to determine the functional suitability of rubber components using a one-size-fits-all approach [1]. In response to a need for a fitness-for-intended-use approach to more accurately select suitable elastomeric components over the product lifecycle, a new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, has been written (to be official in 2025) [2].