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Particles in parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.
At the 2nd PDA Particles in Injectables Conference (Berlin, GE – September 27-28, 2017), Dr. Bettine Boltres, Technical Account Manager in Technical Customer Support (TCS), presented on West’s approach to the issue for elastomer components: Controlling Particle Load in NovaPure® Elastomer Components. Click here to view the science poster in our Particles section of the Knowledge Center.
The first step is an Ishakawa-type cause/effect analysis of the factors that can affect particle loads: materials, equipment, process, people, methods, release/receipt. Understanding these factors, the second step is using Quality-by-Design (QbD) principles to establish a Quality Target Product Profile (QTTP) with low particle (visible and subvisible) levels. By rigorously controlling the factors mentioned, NovaPure components represent the highest levels of particulate risk mitigation across different formulations.
West confirms this – all NovaPure products undergo the West Envision™ automated vision verification inspection process. West is committed to safe and efficient delivery of drug products to patients. NovaPure components, with low particle levels and supplied washed or ready-to-use (sterile), are a key part of that commitment.
For more information, visit the Knowledge Center or contact your TCS representative.
NovaPure® and Envision™ are trademarks or a registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
<em>With employees’ students across the U.S. receiving $5,000 each year over four years, the Foundation fosters a culture of support for education and family at West.</em>
We know that performance, as well as sustainability, are equally important to our customers. For West, we are demonstrating our efforts in critical areas such as carbon neutrality, recycling and reuse of products, and secondary packaging. In addition to our own efforts, we collaborate with our customers and suppliers to solve these challenges, including alignment of Environment, Social, and Governance goals, and efficiency in operation.
The global injectable drug market sees an ever-increasing adoption of high-value biologic drug products. More than half of today’s 20 top selling injectables are biologics, and many of them are delivered in a prefilled syringe. Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass prefilled systems.
The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 2.
West's Applied Research Team will be presenting two scientific posters at the upcoming International Society for Cell and Gene Therapy 2021 New Orleans Annual Meeting taking place online May 26 – 28, 2021.
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