West Introduces Daikyo D4 Elastomer Formulation

West Pharmaceutical Services, a leading US developer and manufacturer of components and systems for injectable drug delivery with sales all over the world, and partner Daikyo Seiko of Tokyo, Japan, have 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 percent vision-inspected, ready-to-sterilise (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 colour 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 sulphur 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, United States and European compendia requirements in all offered configurations.

West says 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; and

·        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