Even though the regulatory landscape is steadily evolving, pharma companies sometimes rely on rubber formulations existing since several decades ago. Legacy rubber components may no longer meet the increasing technical and regulatory requirements of current and future drug products. New rubber formulations are needed.
West is addressing these technical and regulatory requirements through a new elastomer platform. Using the quality-by-design (QbD) approach, the development of the 4040/40 elastomer formulation was focused on raw material selection to make significant progress in mitigating the risk of particulates, extractables & leachables, and functionality.
4040 LyoTec® lyophilization stoppers provide confidence you have chosen a high-performing primary packaging product, de-risking your new drug from development through patient administration. Join us to learn more and engage in a conversation with West team regarding your project needs.
Key Learning Objectives
- Learn the quality-by-design principle in 4040 development
- Discover how 4040 LyoTec® stoppers meet the requirement for manufacturing performance, functionality, quality and safety
About West
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With approximately 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 45 billion components and devices each year.
Headquartered in Exton, Pennsylvania, and in business for nearly a century, West in its fiscal year 2021 generated $2.83 billion in net sales. West is traded on the New York Stock Exchange (NYSE: WST) and is included on the Standard & Poor's 500 index. For more information, visit www.westpharma.com.
