Datwyler StarterPack to be showcased at CPHI North America

Published: 12-Aug-2021

The company’s OmniFlex stoppers are contained in the StarterPack, alongside adaptiQ vials from SCHOTT

At this year’s CPHI North America, Datwyler will feature its StarterPack, a ready-to-use packaging system to support the development of parenteral drugs. Making its North American debut, the kit features components offering sealing compatibility to prevent leaks and other seal integrity concerns throughout manufacturing and handling.

“The stakes are high for drug manufacturers. It is essential to utilise every available tool in preventing contamination throughout the process—especially to ensure a smooth, uninterrupted transition from the development stage to production,” said Glenn Thorpe, Senior VP, Pharma.

The company’s OmniFlex stoppers are contained in the StarterPack, alongside adaptiQ vials from SCHOTT. The stoppers are spray coated with a proprietary fluoropolymer, providing a robust barrier between drug and rubber to minimise extractables and leachables. The pack also contains Datwyler’s PrimeCaps, made with a high quality alloy optimised with an Accurim straight skirt edge to present low bioburden and particulate levels. The combination of these components is designed to offer a comprehensive packaging solution to ensure drug efficacy, stability, and, ultimately, patient safety.

Also on display at the event are the company’s NeoFlex plungers which are designed to offer excellent extractable and leachable profiles while optimising 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, the plungers are constructed with an elastomer compound and are also spray coated with the company’s fluoropolymer coating.

This design guarantees low and consistent break loose and gliding forces, the company says, while preventing leakage and ensuring limited plunger movement during air transport. It also provides a robust barrier between drug and rubber. Application areas include prefilled syringes for manual delivery, prefilled syringes in auto-injectors, cartridges in pen-injectors, and siliconised glass and polymer syringes. Compatible with gamma and steam sterilisation, the plungers are also camera inspected and offered ready-to-use, minimising human intervention.

The same rigorous measures to prevent contamination are also applied to the company’s DuraCoat combiseal, which will also be on display at CPHI. The proprietary technology provides a protective barrier against external forces and reduces the risk of abrasion during manufacturing and handling, combining an aluminium lamination with a high-quality alloy.

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