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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.
The United States Food and Drug Administration issued a draft guidance in March 2013: “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.”
According to the draft guidance,
… there are no regulations requiring a manufacturer to state that natural rubber latex was not used as a material in their medical product or medical product container. If a manufacturer elects to include a statement in medical product labeling indicating that natural rubber latex or synthetic derivatives of natural rubber latex were not used as materials in the manufacture of their medical product and container, FDA recommends the use of the statement “Not made with natural rubber latex.”
Additionally the terms “natural rubber-free” and “latex-free” should be eliminated from use for package labeling.
Because of the concern of patient and caregiver allergic reactions to the proteins found in natural rubber, West’s modern synthetic rubber formulations are widely used for packaging pharmaceutical injectable dosages. By using a synthetic formulation, pharmaceutical manufacturers can reduce concerns regarding risk from allergic reactions to the drug product packaging.
Contact West’s Technical Customer Support to discuss injectable packaging options that are not made with dry natural rubber or natural rubber latex.
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.
<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 />
<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>
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.
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