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West’s Andy Polywacz, VP Quality & Regulatory Affairs, and Jennifer Riter, Sr. Director, Global Analytical Services, will present at the 2015 Interphex conference on April 21-22, 2015. The conference will be held at the Javits Center, New York City, NY.
Andy and Jennifer will present, “Particles Causing End of Line Rejects and Drug Product Recalls: Overcoming Packaging Challenges and Need for Adequate Controls,” at the conference. The session is designed to provide insight into the various sources, causes and concern for particulates from primary and secondary packaging components.
Particles may originate from multiple sources throughout the lifecycle of a pharmaceutical product. Various types and sizes of particles can occur which can be foreign or extrinsic to the process, intrinsic (that is, from within the product or process such as product contact materials), or inherent , which is known to be associated with specific products. Particulates can cause unintended changes to the finished pharmaceutical resulting in potential delays to market, not to mention the risk of costly recalls and shortages. The pharmaceutical ingredients and stability issues can contribute to the particle load as does the environment and manufacturing equipment but it is a well-known fact that materials used in primary and secondary packaging components are often identified. Component manufacturers are tasked with minimizing the particulate load to reduce the contribution to the finished drug product.
Join Andy and Jennifer at Interphex to learn more.
At West, one of our core values is passion for customers. Their success is ultimately our success. Understanding our customers’ unique challenges and focus areas, ultimately helps us to better provide solutions for their needs. Recently, the West China Commercial Team visited one of our major local customers, Wuxi Biologics, and hosted its first large-scale on-site customer event, “Innovation Day.” As one of our major local customers, Wuxi Biologics is a leading company in China’s prosperous biopharmaceutical industry. The event drew over 140 participants and expanded our strategic collaboration, which will help us further support Wuxi Biologics with their specific drug development needs.
<em>This is the second in a two part series dedicated to the origins and attributes of the Daikyo Crystal Zenith® polymer </em>
<em>West is pleased to welcome guest blogger Katrina Firlik, MD, Chief Medical Officer and Co-Founder of </em><a href="https://healthprize.com/"><span style="text-decoration: underline;"><em>HealthPrize Technologies</em></span></a><em>. This is the first installment in a four-part series on the West/HealthPrize collaboration.</em>
The answer is – it depends. Your Technical Customer Service (TCS) representative can help you decide. Butyl rubber, derived synthetically from petrochemicals, is a copolymer of isobutylene, and to a smaller extent, isoprene. Subsequent halogenation results in a halobutyl rubber – typically bromobutyl or chlorobutyl.
One of the main risks associated with drug delivery via vial containment systems is particles that can result from fragmentation and coring of rubber stoppers subjected to needle or spike punctures. This risk can be mitigated by using prefilled syringe systems, whereby the drug dosage has been filled into the syringe by the drug manufacturer. The drug dosage is then administered by subcutaneous or intramuscular injection. A prefilled syringe system generates fewer particles during drug administration, as compared to a vial containment system. Furthermore, this form of drug delivery system ensures efficiency and greater convenience.
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