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TR 2022/258: Think Systems USP 382 - Fragmentation

This is the second of the Technical Report series “Think Systems”.
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].

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