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Beginning in 1998, when an increase in the incidence of pure red cell aplasia (PRCA) was observed in patients with chronic renal failure and associated with the subcutaneous use of Eprex® (epoetin alpha), the U.S Food and Drug Administration (FDA) and European regulatory agencies have paid special attention to leachables in drug products especially resulting from uncoated primary elastomer components.
Current thinking is that biologics may deserve special consideration when selecting a container closure system, because of drug complexity and protein stability challenges, the fact that routine testing may not detect finite changes in the protein and the efficiency of proteins to solubilize leachables.
Pharmaceutical and biopharmaceutical companies can avoid risk and improve drug safety by evaluating several factors critical to primary containment:
With increasing concerns on leachable-related drug product safety, it is especially relevant that West has applied FluroTec® fluoropolymer film barrier to many of its plunger and stopper offerings to deliver a premium solution to customers.
The Eprex issue has been a major milesone for many companies to realize the benefit of FluroTec stoppers and plungers for biologics. On an annual basis, more than 260 million FluroTec plungers are used on marketed drugs delivered in glass syringes or Daikyo Crystal Zenith® syringe systems.
West is proud of its proven regulatory and market track record evidenced through components with FluroTec barrier film. All of the top 35 biologics in a vial or syringe rely on West and Daikyo components with FluroTec Film for barrier properties against potential extractables and formation of leachables. To learn more, visit the West Pharma website.
EPREX is a registered trademark of CENTOCOR ORTHO BIOTECH INC for epoetin alfa injections.
FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
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 />
The supply of sterile pharmaceutical closures into a filling line is an essential element of the production of parenteral drug products. In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as “port bags” or “ported bags.” Port bags contain a “beta” port that is attached to the actual bag <strong>(Figure 1).</strong>
Employees in West’s St. Austell, Cornwall, location raised more than £4152.81 for local charity, Children’s Hospice South West (CHSW). The charity is dedicated to providing the best possible hospice care for life-limited children and their families from southwest England.
West’s Diane Paskiet, Doug Duriez and Gene Polini are among the authors in the recently published <a href="http://www.crcpress.com/product/isbn/9781841848198?utm_medium=Email&utm_source=ExactTarget&utm_term=&utm_content=http://view.email.taylorandfrancis.com/?j=fec615707d62037e&utm_campaign=HLM33E_Encyc_Pharm_Science"><em><span style="text-decoration: underline;">Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition</span></em></a>.
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