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For many years, West has offered several ready-to-sterilize products that are qualified for a minimum 3-log Bacterial Endotoxin Reduction (BER). “Ready-to-sterilize” is known to West customers in Europe as “RS” quality. In other regions, such as South America or Asia, the ready-to-sterilize line of products includes our Superior Clean Product® (SCP) components and Enhanced Performance Products (EPP). These offerings reflect West’s commitment to quality components that support pharmaceuticals and biopharmaceuticals throughout the product lifecycle, while also fulfilling various regional market needs.
However, recent experience has led us to recommend Westar® RS components for our customers filing in the U.S., because of increasingly stringent requirements from the Food and Drug Administration (FDA) for extensive ongoing validation.
Customers who choose RS components select clean components that comply with applicable USP compendial standards and provide consistency of preparation from clinical trials through commercialization. Additionally, West performs a portion of the component preparation process.
Our Westar RS process is backed by an extensive and ongoing validation program employing a comprehensive matrix approach to establish coverage for a broad range of elastomeric products. This information is available to the FDA and Health Canada through our portfolio of Drug Master Files (DMFs), and it has been proven that the Agencies find this validation program to be acceptable.
Based on our experience, customers attempting to register an RS, EPP or SCP component with the FDA may have to commit to transitioning to Westar RS components in order to secure their approvals. Especially for products marketed in the U.S. and/or Canada, consider Westar RS components. To learn more about Westar pharmaceutical stopper and syringe components, click here.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
On May 30, 2015, West employees in Germany donated their time and manpower to support two local non-profit organizations—<a href="http://www.pferde-staerken-online.de/"><span style="text-decoration: underline;">Kids auf Trab</span></a> and <a href="http://zwischenuns-filzbluete.de/?page_id=371"><span style="text-decoration: underline;">Zwischen Uns e.V.</span></a>—with a community day, held under the patronage of Rudi Bertram, mayor of Eschweiler.
A flexible filler is a single filling line capable of processing vials, syringes, and cartridges. Traditionally a filling line is designed to process only one container type. By using a flexible filler, the drug innovator or contract manufacturer can decrease capital expenditure, decrease facility “footprint,” improve product and format-parts change over, and reduce product loss.
<span>Material characterization is an important part of the selection process of containment/delivery systems for parenteral drug products. </span>
Traditionally, drugs and biologics have been sold in vials. Utilizing a vial system requires the use of a syringe or other transfer device to withdraw the medication from the vial and facilitate delivery directly to the patient or to an IV bag for subsequent administration to the patient. These steps can result in errors, spills, contamination, or other mishaps. A simplified approach for administration has been to package the drug or biologic as a <a href="/zh-cn/blog/2022/january/importance-of-prefilled-syringe-packaging-in-market">pre-filled syringe</a> combination product. Drug administration is then made easier because the syringe is both the containment system and the delivery system such that the drug can be directly injected into a patient or into an IV bag port.
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.<br />
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