Preserving the integrity of even the most sensitive product

For highly sensitive applications, Datwyler offers a range of innovative coatings 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 state-of-the-art coatings to ensure 100% integrity of your product.

Superior protection for your product

Datwyler’s state-of-the-art coatings offer several advantages over other alternatives available on the market. Firstly, our coatings cover 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 coatings and their high level of elasticity also eliminate the need for siliconization without compromising the integrity of the container seal.

The Omni flex family

Datwyler’s advanced Omni Flex Plus coating offers even lower levels of residual stickiness, greater safety and improved functional performance. Launched in 2008, the latest generation Omni Flex 3G coating offers the same advantages combined with even greater elasticity and a low extractables profile. Omni Flex 3G is offered in combination with a limited number of product designs, incorporating dimensional features that yield greater safety margins in terms of closure/vial seal integrity. The entire Omni Flex family is exclusively produced in our First Line plant.