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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.
Westar® Select components are created with a simplified regulatory approach that moves away from individual site Drug Master Files (DMF) to a single process DMF inclusive of multiple sites. Westar Select RS components adhere to a single pharmaceutical wash DMF that applies to both West’s Kinston and Waterford facilities – serving to globally harmonize the process. This enables customers to purchase Westar Select components from our Kinston and/or Waterford facilities to flex our capacity without regulatory filing barriers.
The wash process in the Kinston and Waterford manufacturing plants has the same validation documents, simplifying the regulatory strategy. Harmonization between the sites enables customers to reference a single DMF as part of their drug filing which allows for flexibility in supply.
The global harmonization of Westar Select components provides customers with a global product portfolio that enables supply chain flexibility and business continuity support that delivers high-quality, consistent components with a tighter specification. To learn more about Westar Select Components click here or contact a West Technical Customer Service representative here to hear about our global harmonization efforts to simplify the customer journey.
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. <br />
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.
West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.
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.
Focused on meeting customer needs in different markets and regions, West offer two types of washed Ready-to-Sterilize (RS) rubber closures: Regional-Washed RS and Westar<sup>®</sup> RS.