According to the Tufts Center for the Study of Drug Development in 2019, developing a new medicine takes on average 10 years and costs $2.6 billion from discovery through approval. The same study suggests that less than 12 percent of the candidate medicines that make it into phase one clinical trials are approved by authorities.
The stakes are high for drug manufacturers. It is essential to utilize every available tool in preventing contamination throughout the process—especially to ensure a smooth, uninterrupted transition from the development stage to production.
Senior Vice President Pharma
The company’s OmniFlex® stoppers are contained in the StarterPack™ alongside adaptiQ® vials from SCHOTT. The OmniFlex® stoppers are 100 percent spray coated with a proprietary, inert, no-added silicone, fluoropolymer, providing a robust barrier between drug and rubber to minimize extractables and leachables. Datwyler’s StarterPack™ also contains Datwyler’s PrimeCap™ which are made with the highest quality alloy optimized with an Accurim straight skirt edge and present low bioburden and particulate levels. The combination of the Datwyler OmniFlex® stopper, PrimeCap™, and SCHOTT adaptiQ® glass vial, offers a comprehensive packaging solution to ensure drug efficacy, stability, and, ultimately, patient safety.
Also on display are the company’s NeoFlex™ plungers which offer excellent extractable and leachable profiles while optimizing functionality for prefilled syringes and cartridges. Available in 0.5 ml, 1.0 ml and 2.25 ml sizes for prefilled syringes and in 3 ml for cartridges, NeoFlex™ plungers are constructed with a high-quality elastomer compound and also completely spray coated with Datwyler’s proprietary fluoropolymer coating. This design guarantees low and consistent break loose and gliding forces while preventing leakage and ensuring limited plunger movement during air transport. It also provides a robust barrier between drug and rubber as opposed to plungers made from co-molded components that contain areas of naked rubber and pose the risk of residue transfer. Application areas include prefilled syringes for manual delivery, prefilled syringes in auto-injectors, cartridges in pen-injectors, and siliconized glass and polymer syringes. Compatible with gamma and steam sterilization, the plungers are also 100 percent camera inspected and offered ready-to-use, minimizing human intervention as another step toward reducing contaminants.
The same rigorous measures to prevent contamination are also applied to Datwyler’s DuraCoat™ combiseal, which will also be on display at CPHI North America. A proprietary technology that provides a protective barrier against external forces and reduces the risk of abrasion during manufacturing and handling, combines an industry-leading aluminum lamination with a high-quality alloy, the DuraCoat™ combiseal is an optimal solution for high-end cartridge applications.
Datwyler manufactures all of its NeoFlex™ plungers and OmniFlex® stoppers to FirstLine® production standards. At CPHI North America, representatives will be available to discuss how the company’s network of FirstLine® facilities marry best-in-class production technologies with fully integrated cleanroom environments in plant locations across the world to maximize geographical options for sourcing.