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Information is a powerful tool and West’s Knowledge Center has been updated to provide our customers with an improved user experience. We’ve completed a comprehensive overhaul of the Knowledge Center user interface, including a filter-based search design, more modern look and feel, and easy access to trending articles, new content, and FAQ’s answered by West Subject Matter Experts.
West strives to enable the safe and efficient delivery of drug products to patients. As part of that commitment, we launched the West Knowledge Center in 2017 to provide accurate and updated information on topics that impact both our customers and our industry. To date, we’ve supported the information needs of more than 3500 customers.
Our Knowledge Center resources include deep insight into market trends, scientific developments in parenteral packaging and delivery systems, and information on hot topics of interest to our customers, in a variety of content types, including technical reports and bulletins, posters and presentations, and links to webinars and helpful literature. In addition, our Technical Customer Support Portal, exclusively available for current and prospective customers, features:
FAQ articles from West Subject Matter Experts
Product information such as Formulation Characteristics, Drawings, Regulatory Compliance Bulletins, and Extractables
Support documents for products available for our online store such as Example Quality Certificates and Master Specifications
Click here to register for access to our Online Technical Repository, or for current and prospective customers, our Online Technical Customer Support Portal.
As always, our Technical Customer Service team is available to help – contact us today to discuss your needs.
Natural Rubber Latex (NRL) has been a topic of concern in the pharmaceutical industry since the early 1990s. Concerns with allergens prompted labeling guidelines to ensure safe patient treatment. West Pharmaceutical Services’ elastomeric formulations for injectable packaging components for vials and syringes may contain Dry Natural Rubber (DNR) in the form of crepe, but the formulations do not incorporate NRL.
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
<span style="color: #000000;">As a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products, we know that what we do has a direct impact on the health and well-being of our global community. In the second installment of </span><a href="https://www.youtube.com/watch?v=G6cEsnNPUb4"><span style="color: #0000ff; text-decoration: underline;">West On The Road</span></a><span style="color: #000000;"> at our Clearwater, Florida plant, our employees talk about how knowing the impact they’re making on the delivery of healthcare fuels the collaborative dedication at the facility. As one colleague said, “When I’m going home, I go with a satisfaction…I know that I did something that will make a difference in somebody’s life.”</span>
Gene therapies are stored and shipped at ultra-low temperature (approximately -80<sup>o</sup>C, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.