West Introduces the Daikyo D4 Elastomer Formulation
West Pharmaceutical Services, Inc. and partner Daikyo Seiko, Ltd. recently announced the commercial launch of the Daikyo D4 elastomer formulation. To meet the ever-increasing quality demands for sensitive drug products, Daikyo Seiko developed the all-new elastomeric formulation Daikyo D4. Daikyo’s D4 13-mm and 20-mm serum and lyophilization stopper configurations will be available as 100% vision-inspected, Ready-to-Sterilize (RSV) quality from Daikyo Seiko, as well as in sterile Ready-to-Use (Westar RU) quality, as part of the West Ready Pack system.
“The light and translucent color of Daikyo D4 is setting a new standard of aesthetic appearance,” said Erin O’Brien, Senior Director, Marketing, West. “Daikyo D4 allows enhanced visual inspection performance for particulate burden, and can help reduce final drug reject rates due to particulate. Striving for the highest in drug compatibility, chemical purity, and increased risk mitigation, all Daikyo D4 stopper configurations are laminated with Flurotec barrier film.”
A unique benefit of the Daikyo D4 formulation is that it requires significantly shorter drying times than other stopper formulations, which is particularly important for lyophilization applications, and can help to shorten component preparation times. Daikyo D4 is free of sulfur and zinc, which are commonly used curatives in elastomeric formulations that may cause sensitivity in biologics.
The new Daikyo D4 stopper configurations are compliant with Japanese, US, and European compendia requirements in all offered configurations. Daikyo D4 is an ideal solution for:
• Aqueous drug products that might be sensitive to extractables and leachables
• Lyophilized products that could benefit from low-moisture formulations that lead to shorter drying times
• Drug products in need of an aesthetically clean packaging solution
• Drug products intended for global markets
Steam-sterilized stoppers manufactured from the Daikyo D4 formulation are available as part of the West Ready Pack component system, which offers a combination of ready-to-use vials, stoppers, and seals with proven container closure integrity, as well as vial adapters. For more information about the D4 formulation, visit http://www.westpharma.com/en/products/Pages/WestReadyPack.aspx.
West works side-by-side with its healthcare partners from concept to the patient, designing and manufacturing packaging, diagnostic, and delivery systems that promote the efficiency, reliability, and safety of their products. For more information, visit www.westpharma.com.
Since the company’s founding in 1954, Daikyo Seiko has pursued the goal of safer and higher quality products with its unique development capability and manufacturing technology. Today, Daikyo is highly regarded globally as a pharmaceutical packaging and medical device component manufacturer. For more information, visit www.daikyoseiko.jp.
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