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In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
West is addressing these regulatory and market requirements through a new elastomer platform. The West 4040/40 elastomer platform has been developed using the quality-by-design (QbD) approach. A predefined quality target product profile (QTPP) that emphasizes product and process understanding was used to evaluate all potential raw materials. Initial selection of raw materials leveraged historic knowledge of formulation chemistry. Further, the raw materials’ chemical/physical properties were critically analyzed to identify alternate sources, should they be required.
Using the QbD approach, the 4040 elastomer platform delivers in the key areas of:
The breadth and depth of documented knowledge for the 4040/40 elastomer sets it apart from any historic elastomer platforms in the market. The knowledge space around the 4040/40 elastomer platform supports the increased demands of Knowledge Management by regulators. Developing high performing elastomers/components is just one example of West's commitment to the safe and efficient delivery of drug products to patients.
Click here for more information on the 4040 LyoTec® stopper.
Westar® and LyoTec® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
For any drug, selection of the appropriate primary packaging components is essential to having a containment system that ensures quality, safety, and stability. The primary packaging components are selected based on various factors, which include chemical compatibility with the drug product ingredients and dimensional fit with mating packaging components. Optimized fit among mating packaging components is essential for flawless fill-finish processing.
At West, one of our core values is passion for customers. Their success is ultimately our success. Understanding our customers’ unique challenges and focus areas, ultimately helps us to better provide solutions for their needs. Recently, the West China Commercial Team visited one of our major local customers, Wuxi Biologics, and hosted its first large-scale on-site customer event, “Innovation Day.” As one of our major local customers, Wuxi Biologics is a leading company in China’s prosperous biopharmaceutical industry. The event drew over 140 participants and expanded our strategic collaboration, which will help us further support Wuxi Biologics with their specific drug development needs.
West is pleased to announce that our new Online Store is now available on westpharma.com! The Online Store is a one-stop solution for access to small quantities of some of West’s highest quality products available ready-to-use in convenient small packs.<br />
On May 30, 2015, West employees in Germany donated their time and manpower to support two local non-profit organizations—<a href="http://www.pferde-staerken-online.de/"><span style="text-decoration: underline;">Kids auf Trab</span></a> and <a href="http://zwischenuns-filzbluete.de/?page_id=371"><span style="text-decoration: underline;">Zwischen Uns e.V.</span></a>—with a community day, held under the patronage of Rudi Bertram, mayor of Eschweiler.
Defined under US FDA 21 CFR 3.2 (e)(2), a <em>co-packaged combination product</em> consists of “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products”. (1) These device products can range from delivery devices, to bandages, to antimicrobial swabs. Understanding the regulations around such a wide range of devices can be challenging; drug companies often look to the device manufacturer/provider for guidance when filing.
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