USP Proposal for Elastomeric Packaging Components

A  revised version of USP chapter <381> Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems has been published in Pharmacopeial Forum PF 50(4). The deadline for comment is 30 September 2024.

Background

The General Chapters—Packaging and Distribution Expert Committee is proposing to remove the Functionality Tests section, as this section will be redundant due to the introduction of chapter <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, which will become official on 1 December 2025.

Chapter <382> focuses on the evaluation of the functional suitability of packaging and delivery systems intended for parenteral dosage forms, in particular those involving primary packaging components made partly or wholly of elastomeric materials. Elastomeric components, when properly integrated into dimensionally compatible packaging and delivery systems, serve the purpose of protecting and containing the package contents while providing safe and effective access to the product during use. Chapter <382> was officially incorporated into the USP-NF on 1 December 2020, with a 5-year implementation delay to allow industry sufficient time for adoption. Therefore, the proposed revision to remove the section on functional testing aims to ensure harmonization of chapters <381> and <382>.

 More information is available after registration to the Pharmacopeial Forum.