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Allergy to natural rubber latex was first documented in the late 1970s. The condition now commonly known as “Latex allergy” is caused by the proteins produced from the rubber tree (Hevea brasiliensis) that are still present in the products manufactured from natural rubber latex. This allergy is not only caused by the proteins, but also by the chemicals and/or residues thereof.
Even though people are aware of this allergy, many do not realize that there is a difference between the various terms “latex,” “natural rubber,” “natural rubber latex” and “dry natural rubber” and often use them interchangeably and incorrectly. This article may help medical device/drug manufacturers, medical staffs and end-users to gain some clarity on the terms, as well as West’s “natural rubber” labelling per labelling guidance by the U.S. Food and Drug Administration (FDA).
At West, natural rubber latex is not used in the manufacture of our products. On the other hand, dry natural rubber is used in some West’s formulations. West certifies the absence or presence of dry natural rubber in West rubber formulations per the FDA’s guidance, by using the terminology: This Product Contains Dry Natural Rubber.
Please contact West’s Technical Customer Support for more info about the formulation/product range available in West with/without dry natural rubber.
West’s Peg Frandolig and Lynn Lundy share how vision inspection systems can help drug product manufacturers and packaging suppliers work together to regulate foreign and particulate matter in finished drug products in the December/January issue of <em>Pharmaceutical Formulation & Quality</em>.
West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.
There is increasing demand for advanced manufacturing technologies for fill-finish operations of parenteral drug products. To meet manufacturing requirements for multiple container and component types, flexible fill-finish equipment is at the forefront of most pharmaceutical, biotech, and CDMOs’ fill-finish strategy. Flexible fill-finish technology is suitable for variable batch sizes allowing for scaling from clinical to commercial in multiple drug delivery presentations. With the ability to launch in vial configurations, prefilled syringes, or other combination products including devices, flexible fillers are beneficial to drug developers who are looking for lifecycle management of their drug products.
West is pleased to announce that it has become a multi-year foundation sponsor of the <a href="http://ymicfoundation.org/" title="Young Men In Charge Foundation, Inc." target="_blank"><span style="text-decoration: underline;">Young Men In Charge Foundation, Inc.</span></a> (YMIC). The program is dedicated to increasing the number of African American and Latino males in science, technology, engineering and math (STEM). West’s sponsorship will support the Foundation’s mission of integrating STEM exposure and mentoring with a focus on leadership, business and social skills.
West is pleased to announce that we’ve recently expanded our Online Store offerings to include a 20mm NovaPure<sup>®</sup> Ready Pack™ lyophilization stopper, adaptiQ<sup>®</sup> vials from SCHOTT and Ready Pack™ Flip-Off<sup>®</sup> CCS (Clean, Certified, Sterilized) seals. West’s Online Store is a one-stop solution for access to small quantities of some of West’s highest quality products, in stock and available ready-to-use in convenient small packs. Depending on their product needs, shoppers can now purchase a complete vial containment system with the option of selecting either Daikyo Crystal Zenith<sup>®</sup> or adaptiQ glass vials.
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