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When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers.
West’s global premier elastomer formulations include 4023/50 and 4432/50. Steam sterilization is now also available for ready-to-use plungers , which can help companies moving from a vial and stopper combination to prefillable syringe system. Because the same elastomer formulation can be used to manufacture stopper and plunger configurations , manufacturers can move from the initial container closure system to a prefillable syringe system with minimal data on component to drug product compatibility. While stability testing still needs to occur, maintaining the same elastomer formulation in a different configuration, can reduce risks associated with a new formula selection because chemical compatibility, toxicity data and extractables profiles will remain the same. For example, both vial stoppers and syringe plungers are available in formulation 4432/50 and in a steam sterilized format.
Also, maintaining components with the same elastomer formulation can be safe for patients because the formulation has been proven to work with the drug product, and the manufacturer is aware of any possible interaction between the product and components.
West offers steam-sterilized components in the 4432/50 and 4023/50 formulations that provide functionality and compatibility in a variety of container closure and delivery systems. Contact West today to discuss the best options for your drug product.
Many of the top-selling biologic drug products will soon come off-patent. As a result, according to IMS, the biosimilar market is expected to reach between US$1.9-2.6 billion by 2015.
Lyophilization (freeze drying) is the process of dehydrating a drug product at low temperature and reduced pressure. Absent water, degradation processes are greatly reduced; thus, it helps to enhance drug product stability. Moisture-sensitive drug products are often marketed in lyophilized form. For a primary package system, the selection of appropriate components is essential to prevent risks associated with alteration of the lyophilized drug product prior to reconstitution and use.
The global pen injector and auto-injector markets have witnessed significant growth due to the increasing demand for self-administration of injectable drugs. Pen injectors and auto-injectors provide a user-friendly and convenient solution for patients to administer medications, contributing to improved patient compliance and overall healthcare outcomes. There are well established traditional market segments that use cartridge-based delivery systems, including dental local anesthesia and diabetes care, as well as human growth hormone and allergy therapies. However, there have been significant developments in the incorporation of cartridges in auto-injectors as supposed to the traditional syringe designs.
When combined with the industry trends of increased regulatory scrutiny and higher focus on patient safety, risk management, and compliance, the market is seeing an increased need for high-quality drug delivery systems such as prefillable syringes.
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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