Understanding Global Compendial Specifications: Elastomers
Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.
Monitoring compendia is also critical, since they are updated as needed to meet the ever-changing needs of the industry and regulatory markets. West monitors compendial requirements thoroughly, knowing testing requirements for each characteristic and when changes are forthcoming. An example is the elastomeric requirements in USP <381> Elastomeric Closures for Injections: this document is currently being modernized and three new, related documents are being created to reflect the need for better understanding of component materials and suitability for use. As the pharmaceutical industry evolves, and specifications change, West will remain up-to-date. This level of understanding not only ensures West facilities manufacture and evaluate elastomeric components properly, but also enables West to assist customers world-wide to navigate the very complex regulatory landscape.
For more information about current and upcoming global specifications for elastomers, please visit the Industry Trends/ Regulatory section of West’s Knowledge Center here.
To discuss compliance and certifications for West products, please contact Technical Support using this form.