To meet the requirements of sensitive drug products
West Pharmaceutical Services, a US manufacturer of components and systems for injectable drug delivery, and partner Daikyo Seiko of Tokyo, Japan, have launched the Daikyo D4 elastomer stopper to meet the requirements of sensitive drug products.
Daikyo’s D4 13mm and 20mm serum and lyophilisation stopper configurations will be available as 100% vision-inspected, Ready-to-Sterilise (RSV) quality from Daikyo Seiko, as well as in sterile Ready-to-Use (Westar RU) quality, as part of West's Ready Pack system, which offers a combination of ready-to-use vials, stoppers and seals with proven container closure integrity, as well as vial adapters.
'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.'
West says one benefit of the Daikyo D4 formulation is that it requires significantly shorter drying times than other stopper formulations, which is particularly important for lyophilisation 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.
West says the D4 is suitable for aqueous drug products that might be sensitive to extractables and leachables; lyophilised 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.