USP 382 Elastomeric Component Functional Suitability in Parenteral Product Packaging Systems

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 Systems1 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 Systems,2 to a holistic evaluation of these components when assembled into drug product packaging and delivery systems.

Your Approach to USP <382> for Your Drug Product Packaging: Think Systems, Not Components

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Read time :

11.7 minutes

Understanding the differences between USP <381> and USP <382>

The scope of USP <382> as it relates to packaging systems

Testing methodologies on a packaging system to meet USP <382>

1. USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems; United States Pharmacopeia
2. USP <381> Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems; United States Pharmacopeia

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Your Approach to USP <382> for Your Drug Product Packaging: Think Systems, Not Components

Your Approach to USP <382> for Your Drug Product Packaging: Think Systems, Not Components

Your Approach to USP for Your Drug Product Packaging: Think Systems, Not Components