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In the latest installment of our video series, West on the Road, we travel across the Atlantic to our manufacturing facility in Eschweiler, Germany. There we meet Manager of Process Engineering Martin Rothstein, who says he’s impressed at how often he has encountered West products in his private life, whether visiting a family member in the hospital or during a vaccination appointment for one of his two small children.
Rothstein and the teams at the Eschweiler facility produce high-value pharmaceutical packaging products, turning materials into high-quality elastomeric stoppers, plungers and other components for the biotech and pharmaceutical industries. With the biopharmaceutical industry experiencing a shift toward patient-centered, quality care, it is increasingly important to maintain strict manufacturing processes to decrease risk. With this in mind, Rothstein explains that for many customers, it’s important to work with a provider such as West that manufacturers all of the various packaging components for a drug product under one roof, ensuring minimal risk.
The teams at Eschweiler have a long history of providing high-quality components; they possess a deep knowledge of the production process and are able to provide the right support to the customers to help them improve patient care around the world. Check out this new video to learn more about the work being done at West’s Eschweiler facility and visit our Careers page to learn more bout working at West in Germany.
West is proud to announce that Diane Paskiet, Director, Scientific Affairs will serve as Co-chair at the upcoming PDA Packaging Conference in Baltimore, MD. In her leadership role for the meeting, Diane will moderate several sessions, including <em>Repackaging – Problems and Solutions</em> and <em>The Future Direction of Devices and Patient Adherence/Compliance</em>.
The drive for high-quality packaging has helped manufacturers focus on increasing consistency of performance in devices such as auto-injector and patch injection systems. In addition, there is an increased focus on providing drug delivery systems that are easy to use. A consistent quality of components can help to improve performance and ensure delivery in the home environment, while user-centric systems can help assist with compliance.
We’re excited to share that Amgen has selected West’s Daikyo Crystal Zenith® vials with FluroTec® stoppers to contain its FDA-approved therapy IMLYGIC™ (talimogene laherparepvec).
The two most common means of sterilizing elastomeric parenteral packaging components are steam autoclave and gamma irradiation processes. When appropriately validated, both processes are very effective at eliminating concerns around microbial contamination of the components used for container closure of sterile liquid, lyophilized or powder drug products. Despite the ability of both methods to reach the required sterilization specifications and requirements, the overall impact that these processes have on the elastomeric component can be quite different.
Extractables and leachables (E&L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&L, which has led the <em>Center for Drug Evaluation</em> under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): <em>Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures.</em> The compatibility study discussed therein focused on E&L.
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