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Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Our Integrated Solutions program brings together West’s primary packaging, device, analytical, regulatory and contract manufacturing expertise in a single-source solution. West can help you Simplify the Journey™ at any stage of drug development. Learn more by visiting our Integrated Solutions Program page or contact a technical representative today for additional support and guidance.
It is essential to consider lifecycle management during the development of new drugs – especially in the evolving area of biologic drugs. The market demand for both ease of use, and patient-centric at-home administration, is driving the need for innovative container systems and delivery devices. Typically, drugs are launched in vials; continuous development often then enables launch in other formats, such as pre-filled syringes and cartridges. West is committed to easing this movement from container systems to delivery devices through its NovaPure<sup>®</sup> component portfolio of elastomer closures. NovaPure stoppers and plungers offer best performance and highest quality. Developed with Quality-by-Design principles, they use FluroTec<sup>®</sup> barrier film and B2 coating technologies.
Join our subject matter experts in Boston for the 2013 Educational Series, “Supplying Safe Medicines to Patients: Considerations for Container Closure and Delivery Systems.”
Here at West, we are working by the side of our patients and customers to help contribute to a healthier world. Meet one of our team members, Rusli Kartadinata, and read his story to learn how he grew in his career at West from a Production Engineer to his current role as the Associate Quality Manager across Asia Pacific.
The complexity of bringing a combination product, such as an on-body delivery system (OBDS), to market cannot be overstated. Changing or unclear regulations are often cited by the industry as a major source of confusion which contributes to that complexity. However, continuous incorporation of updated standards and newly issued guidance documents during the development process can reduce risk, improve patient safety, save time and headaches when the submission date ultimately approaches.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.