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USP <382> Compliance for Injectable Drug Delivery Systems: Functional Testing of Elastomeric Components - White Paper

来源: | 作者:pmo90dc87 | 发布时间 :2025-12-05 | 60 次浏览: | 分享到:

USP <382> is a chapter in the United States Pharmacopeia (USP) that provides requirements for elastomeric closures for injections (e.g., rubber stoppers, plungers, seals used in pre-filled syringes, vials, cartridges, and other parenteral packaging systems).

It is part of a broader set of USP standards for container–closure systems that come into direct contact with drug products.