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As the need for higher quality drug delivery and packaging components increases, customers are challenged to meet new standards and comply with additional regulatory requirements. To help our pharmaceutical and biopharmaceutical partners meet these challenges and reduce risk, West has developed next-generation quality for ready-to-sterilize and ready-to-use components.
Westar® Select components, the latest in West’s industry-leading Westar quality enhancement offering, helps reduce variability and its effects on drug quality, safety and efficacy. The new Westar Select components offer even tighter particulate specification, a defined Global Product Portfolio focused on component capability, and a simplified regulatory strategy. Westar Select components will be available through an optimized global manufacturing network with multi-site production capabilities to help ensure a continuous supply chain, while reducing regulatory complexity for customers.
With Westar Select components, customers get high-quality, consistent components with a single, global Drug Master File covering multiple West manufacturing sites.
Visit the Westar Select product page to learn more.
Westar® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
In the pharmaceutical and biopharmaceutical industry, customers are challenged with the need for higher quality product options and a flexible supply chain. Quality standards are everchanging, and to help customers meet regulatory filing complexity, West has developed next-generation quality for ready-to-sterilize (RS) and ready-to-use (RU) components in an effort to provide a solution for those challenges while establishing a new regulatory strategy designed for risk mitigation.<br />
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
Component processing is a source of risk and variability, especially for loose particulate and silicone oil that can compromise quality, putting patients at risk. To simplify drug development and streamline manufacturing, pharmaceutical companies can select cartridge plungers and lined seals in a ready-to-use format.
West has been on a multi-year journey to evolve its manufacturing strategy based on customer needs. With an advanced global network of manufacturing sites, we work each day to improve our service to customers and help them to mitigate the risks of drug development and delivery.
For many years, West has offered several ready-to-sterilize products that are qualified for a minimum 3-log Bacterial Endotoxin Reduction (BER). “Ready-to-sterilize” is known to West customers in Europe as “RS” quality. In other regions, such as South America or Asia, the ready-to-sterilize line of products includes our Superior Clean Product® (SCP) components and Enhanced Performance Products (EPP). These offerings reflect West’s commitment to quality components that support pharmaceuticals and biopharmaceuticals throughout the product lifecycle, while also fulfilling various regional market needs.
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