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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.
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.
<p>The needle of a pre-filled syringe is extremely important. From manufacture, through packaging/transportation, to patient delivery – if the needle is not protected, the drug product cannot be delivered effectively. To protect needles to ensure patient safety, West has developed <a href="/products/prefillable-systems/syringe-components/rigid-needle-shields-and-tip-caps">Rigid Needle Shields </a>(RNS) in two sizes: 1/2” for subcutaneous injections (e.g., heparins) and 5/8” for intramuscular injections (e.g., vaccines). RNS consist of a two-part system – a soft rubber inner shell and a perforated, hard polypropylene outer shell. This system maintains container closure integrity (CCI) for both an ISO 11040 glass syringe with staked needle, and a polymer-based syringe (e.g., <a href="/products/prefillable-systems/daikyo-syringe-systems/insert-needle-syringe-components">Daikyo Crystal Zenith® insert needle syringe</a>).</p>
The first thought that you may have when you hear the word “rubber” is natural rubber – a poly-isoprene-based polymer, which has as its origination the latex fluid drawn from rubber trees (most prominently in Indonesia and Malaysia). Although natural rubber has been used in the past for pharmaceutical applications, potential issues with latex allergies resultant from proteins from the original latex, have led to the almost complete adoption of synthetic rubber.<br />
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.
<p><strong>J. Riter, A. Janssen, D. Engels</strong></p><p>Cracking of elastomeric needle shields and tip caps is a costly problem for pharmaceutical manufacturers. Cracked components can cause leaks that can result in loss of drug potency and sterility and may lead to a safety risk for the person administering the drug and the patient. This cracking has been attributed to ozone degradation of the elastomer formulations.</p>
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