USP <382>: Think Systems; Not Components - Packaging/Delivery System Integrity And Needle Self-Sealing Capacity Of Vial Systems


General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.

This blog reviews the scope of USP Chapter <382>, USP Chapter <1207>, the USP <382> testing procedure, and FDA Helium leak detection.

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