Fueled by our passion for patient care and safety, we take a quality-first approach to engineer drug packaging components with a proprietary fluoropolymer coating to deliver the lowest particle levels. This adds up to better protection of injectable formulations against leachables, extractables, and particulate contamination that could threaten the effectiveness and integrity of medicines.
Bolstered by a century of material expertise, our team is equipped to raise the bar in custom component design, risk mitigation, supply chain agility, and scalability from drug development to distribution.
100years
of material expertise
600customers
across 65 countries
17billion
components every year
Zerodefects
is our mission
Datwyler Healthcare CEO, Dirk Borghs, discusses Datwyler’s FirstLine® manufacturing standard, recent investments and expansions of the company’s global footprint, and its highest quality coated elastomers for sensitive drugs.
At Datwyler, we put care, quality, and drug integrity first. Because we care.
OmniFlex® Stoppers are co-molded and 100% spray coated with Datwyler’s proprietary inert fluoropolymer coating to protect drug formulations, minimize silicone contamination with a no-added silicone design, and keep leachables, extractables, and particle contamination out.
NeoFlex™ Plungers offer consistent break loose and gliding forces for syringes and cartridges with no-added silicone.
DuraCoat™ Combiseals: Next-gen aluminum seals combine high-quality alloy with protective laminate.
PrimeCap™ for flawless machinability on highspeed vial filling lines.
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The manufacturing process at these facilities includes the following:
The FirstLine® network of locations around the world — including our plant in Middletown, Delaware — ensures multinational options for sourcing. The Middletown FirstLine® facility not only offers all of the above features, it also minimizes cellulose contamination by banning paper and wood products on the plant floor. Learn more by downloading our FirstLine® overview or request a virtual tour.
Datwyler pioneered the FirstLine® manufacturing standard to better protect drug formulation integrity and ultimately patients, by applying a «Quality First» approach to manufacturing that combines cleanroom technology and automation. Learn more about FirstLine® in our white paper.
Elastomer Manufacturing Process
Datwyler StarterPack™
SCALABILITY
For biotech accelerators and incubators as well as established R&D operations, Datwyler’s StarterPack™ offers a comprehensive packaging solution for early drug development. Contents include Datwyler OmniFlex® stoppers, PrimeCap™, and SCHOTT adaptiQ® glass vials — all ready to use — for a compatible packaging solution that offers drug efficacy, stability, scalability, and, ultimately, patient safety.
Datwyler’s Design Your Seal app helps to bridge the gap between Datwyler’s design process and the customer’s brand needs. Download it to start mixing and matching aluminum seals and plastic discs. Once the designs are complete, the physical samples are assembled and shipped to the customer for evaluation.
For more information, please download the app.
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