USP <381>/ PH. EUR 3.2.9 Combined Protocol – Functional Tests

Standards are established for the evaluation of elastomeric closures for injection for the pharmaceutical industry by the United States Pharmacopeia (USP) <381> “Elastomeric Closures for Injection” and the European Pharmacopeia (Ph. Eur) 3.2.9 “Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders”. West Analytical Services has established a combined protocol that satisfies both USP and Ph. Eur Functional tests to provide our customers with testing that covers both markets but at a value of being able to perform a single set of tests. West item number: 35001128

TSB 2009/032 The Harmonization of USP <381> and Ph. Eur. 3.2.9

West’s comprehensive Integrated Solutions Program offers expert testing to support drug product containment systems throughout the development process. Our technical expertise for pharmaceutical packaging includes vials, stoppers, and seals, with an in-depth understanding of regulations and market requirements, including USP <1207>. A dedicated Project Management team will help to identify key stakeholders to provide consultation and the creation of a customized study design.