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Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.
Globally available AccelTRA stoppers were designed using West’s 4031/45 formulation: a high-performance, bromobutyl formula offering multi-puncture capability with low particulates and a low extractables profile. The 4031/45 formulation meets strict regulatory standards – including compliance with the US and EU Pharmacopeias to 24 months and the Japanese Pharmacopeia to 18 months. Ongoing, real-time testing continues to obtain JP compliance to 24 months in early 2019. This compliance is critical because it highlights the high elastomer quality customers are able to access with AccelTRA components.
Additionally, West recognizes the importance of speed to market and offers a quick order fulfillment response to help customers improve their product’s speed to market with the AccelTRA component program. Optimizing lead times has enabled customers to receive component samples in as little as one week and commercial quantities in as little as six weeks.
AccelTRA component customers also benefit from access to a robust Extractables Report that includes summaries of studies conducted with three different pH ranges and three different solvents to assist with compatibility and risk assessment analyses for drug products are provided.
During the past year, West provided more than 10 million AccelTRA sample components to 200 customers seeking the benefits of quality, speed and simplicity offered by the AccelTRA elastomer component program.
Click here to order samples and learn more about how the AccelTRA™ elastomer component program can help your organization move products to market fast.
AccelTRA™ is a trademark of West Phamaceutical Services, Inc. in the United States and other jurisdictions.
Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.
To ensure drug product efficacy, components of primary packaging and delivery systems must be evaluated for safety and performance. An essential aspect of this is an extractables and leachables (E&L) study. The purpose of an E&L study is to identify compounds (organic and inorganic) that may migrate from components into drug product formulations, in particular those that may put patient safety at risk.
Supporting the health and well-being of our team members across the world is very important to us at West. Well-being often refers to happiness, quality of life, thriving and flourishing. Well-being can be described as the way you feel, the way you function and how you judge your life. It’s also a consideration of the “whole person.”
The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbreviated 510(K)s and the new Refuse to Accept policy for 510(K).
<p>Integrity of a drug product container/delivery system is essential to guarantee safety and efficacy. USP has recently issued <em>Chapter <1207> “Package Integrity Evaluation – Sterile Products”</em>—a guidance for the pharmaceutical industry in measuring container closure integrity (CCI). In line with this guidance, West has just expanded its capability in measuring CCI by adding<strong> high-voltage leak detection (HVLD)</strong> –a method endorsed in Chapter <1207>.</p><p> </p><br>
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