USP <381> / EP 3.2.9 Elastomeric Closures

Date: April 05, 2017

Elastomeric closures for containers used in parenteral preparations are made of materials obtained by vulcanization (cross-linking) polymerization, polyaddition or polycondensation of macromolecular organic substances (elastomers). They may be formulated from natural or synthetic elastomeric substances and inorganic and organic additives, which aid or control vulcanization, impart physical and chemical properties or color or stabilize the closure formulation.

General Chapters

- USP <381> Elastomeric Closures for Injection Includes Extractable and Functionality Testing

Download General Chapter <381> Elastomeric Closures for Injections Type: PDF File | Size: 73.1 Kb

- EP (3.2.9) Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders includes Identification, Extractable and Functionality Testing

Download (Ph. Eur.), Chapter 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders Type: PDF File | Size: 74 Kb

The revision of the United States Pharmacopoeia (USP) General Chapter <381> Elastomeric Closures for Injection dating from May 2009 harmonised it with the European Pharmacopoeia (Ph. Eur.), Chapter 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders.

The table below represents a side-by-side comparison of the tests outlined in the Ph. Eur. and the USP.