Preserving the integrity of even the most sensitive product

For highly sensitive applications, Datwyler offers a range of coated components offering the lowest possible extractables and leachables profile without compromising on seal integrity.

 

The challenge of compatibility

For applications involving long-term contact with parenterals, Datwyler always uses the most advanced compounds exhibiting extremely little to no interaction with the contents. For some pharmaceutical applications, however, such as biotech drugs administered in very small quantities per dose, there is no margin at all for absorption or any kind of interaction on the part of the vial stopper or syringe plunger. In such cases, Datwyler offers a range of fluoropolymer spray coated components to ensure 100% integrity of your product.

Superior protection for your product

Datwyler’s proprietary fluoropolymer spray coating offers several advantages over other alternatives available on the market. Firstly, our coating covers the entire product surface and not just the contact zone, guaranteeing the maximum integrity of the fluoropolymer layer itself and a more effective barrier between the rubber component and your product. The coating prevents the leaching of compounds from the stopper into the drug and vice versa, which, in combination with the inert characteristics of fluoropolymers leads to better stopper/drug compatibility. The non-sticky surface of Datwyler's fluoropolymer coating and its high level of elasticity also eliminates the need for siliconization without compromising the integrity of the container seal.

Coated Elastomer Platforms for Vials, Prefilled Syringes, and Cartridges

Datwyler's coated sealing solutions are available in two platforms: OmniFlexTM stoppers for vials and NeoFlexTM plungers for prefilled syringes and cartridges. Both the stoppers and plungers are coated using the exact same spray coating technology, with 100% coverage of the component. Both the OmniFlex stoppers and NeoFlex plungers are compatible with most standard vials, syringes, and cartridges in the market.