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In Part 1 of our West on the Road – Eschweiler series, we learned about the high-value products produced in our Eschweiler, Germany facility and how this dedicated team of manufacturing experts supports customers in their mission to bring critical medicines to patients. In Part 2, we learn from Lukas Buglowski, Team Lead of Engineering, Envision, about how a focus on quality is both a shared mindset and built into every step of the manufacturing process in Eschweiler. Buglowski shares the pride his team feels knowing that they are producing high-quality products that will not only meet customers’ expectations, but more importantly, ensure patient safety, and how this builds trust and makes for a great team dynamic.
We also learn from Manager of Process Engineering Martin Rothstein about another pride-boosting element about working at Eschweiler: the fact that teams are plugged into and collaborating with West’s global network, regularly providing support to other manufacturing plants around the world. Check out this latest video to see the Eschweiler team in action.
Christa Jansen-Otten and Dr. Heike Kofler will moderate the ”Prefillable Glass Syringe and the Appropriate Pharmaceutical Rubber Components: Processing, Packaging, Innovations,” at the 53° SIMPOSIO AFI in Rimini, Italy, on June 12-14, 2013.
Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent <a href="http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html"><span style="color: #0000ff; text-decoration: underline;">paper</span></a>, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
Drug developers must understand and mitigate the risk of various chemical entities (leachables) migrating from any material that comes into contact with their drug product. Failure to execute an appropriate extractables and leachables assessment could lead to failures in meeting agency expectations and a delay in drug development timelines.
What does it mean to have package integrity for your container closure system? It means an absence of breaches that can lead to product loss or ingress. Container closure integrity testing should not be just a “one and done” study. It should be understood throughout the life cycle of the product.
<p>West is pleased to announce that the company has received the 2017 “Supplier of the Year in Quality Award” from long-time customer, Bristol-Myers Squibb (BMS). The award is based on West’s excellent performance in quality, along with our flawless quality track record and responsiveness with diligent site engagement.</p>