Quality First. Comprise Never.
Unparalleled precision.
Seamless scalability.
Datwyler offers an extensive portfolio of sealing solutions for vials, cartridges, and prefilled syringes used in the development, distribution, and administration of parenteral drugs.
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.
100 years
of material expertise
600 customers
across 65 countries
17 billion
components every year
Zero defects
is our mission
Latest news
Introduction of Ready-For-Sterilization Combiseals
Ready-for-sterilization (RFS) combiseals for cartridges take the burden off drug manufacturers to prep packaging components for sterilization, saving time and cost while complying with FDA and EU regulations.
Datwyler Representative receives PDA Award 2022
Dr. Renaud Janssen, longtime Head of Technical Services at Datwyler, was recognized by PDA for his diverse and valuable contributions to the field of pharmaceutical packaging science with the Edward Smith Packaging Science Award.
Datwyler as first supplier of film and spray coatings for Healthcare components
Datwyler introduces its own film coating technology, becoming the first and sole supplier capable of offering both film and spray fluoropolymer coating technologies for elastomeric closures.
Sustainable healthcare solutions for the pharma industry
Datwyler’s award-winning sustainability work is helping the global pharmaceutical market transform into a greener, more environmentally friendly industry.
Datwyler adds steam sterilization option for ready-to-use components for injectable drugs
Datwyler will deliver RTU components in robust packaging guaranteeing a shelf life of 2 years after steam sterilization.
FirstLine® – Datwyler’s best-in-class manufacturing standard
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.
Webinars
Looking to the Future of Parenteral Packaging.
View our recent webinars on Pandemic Preparedness: Ensuring a Robust Parenteral Packaging Supply Chain and Parenteral Packaging for Cartridges in Drug Delivery Devices.
Sterilization Techniques for Parenteral Packaging
CPhI North America
Product Innovations Presentation. On-demand: Parenteral Packaging Selection Process for Drug Delivery Devices.
Parenteral Packaging for Cartridges in Drug Delivery Devices.
Webinar (Recording available)
Pandemic Preparedness: Ensuring a Robust Parenteral Packaging Supply Chain
(Recording available)
During Challenging Times, The Path to Patient Safety Starts with Datwyler.
At Datwyler, we put care, quality, and drug integrity first. Because we care.
Solutions Spotlight
OmniFlex®
Stoppers
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.
→ Download brochure
Learn more
→ Download brochure
Learn more
NeoFlex™
Plungers
NeoFlex™ Plungers offer consistent break loose and gliding forces for syringes and cartridges with no-added silicone.
→ Download brochure
Learn more
→ Download brochure
Learn more
DuraCoat™ Combiseals
DuraCoat™ Combiseals: Next-gen aluminum seals combine high-quality alloy with protective laminate.
→ Download brochure
Learn more
→ Download brochure
Learn more
PrimeCap™
PrimeCap™ for flawless machinability on highspeed vial filling lines.
→ Download brochure
Learn more
→ Download brochure
Learn more
Contact
Speak to a Representative.
Quality-First Approach
What is a Quality-First Approach to Pharmaceutical Packaging?
Datwyler’s FirstLine® manufacturing standard combines best-in-class production technologies with fully integrated cleanroom environments.
The manufacturing process at these facilities includes the following:
- Automated “hands-free” production, minimizing human intervention
- 100 percent camera inspection
- Components packaged ready-to-use (RTU)
- Packaging of components in vacuum-sealed bags.
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.
White Paper
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.
COVID-19
Driving Solutions to COVID-19 Shortage Concerns.
Datwyler has been working with industry leaders to develop sealing solutions for the multiple COVID-19 vaccine candidates. Amid industrywide concerns about shortages, we are in an excellent position to meet projected demand for stoppers and aluminum seals for vaccine packaging. Our team is preparing for increased capacity demands and rapid scale-up in our facilities all over the globe.
The addition of our FirstLine® facility in Middletown, Delaware has provided critical infrastructure to help support the increased demand around COVID-19. By scaling up this facility faster than originally planned and ramping up production with a 24/7 schedule worldwide, we’ve increased capacity for coated components by almost 50% over the last two years and have more investments to optimize the use of our production facilities in the pipeline. These measures not only ensure our readiness for COVID-19, but also enable continued production of sealing solutions for injectable drug packaging used in other medicines.
SCALABILITY
Start Off on the Right Track to Scale Up Datwyler’s StarterPack™
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.
Application
Design Your Seal App.
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.
Press
Find Our Experts in the Media.
Datwyler Introduces Ready-for-Sterilization Combiseals to Enhance Efficiency in Drug Filling & Packaging
Datwyler recently announces the launch of its ready-for-sterilization (RFS) combiseals for cartridges that are used in injection devices such as pens and autoinjectors.
Datwyler combiseals to reduce burden on pharma manufacturers
Washing and sterilization of rubber materials is more and more done by the rubber manufacturers.
Datwyler Launches RFS Combiseals for Cartridges
These components take the burden off drug manufacturers to prep packaging components for sterilization, while helping to enhance the drug filling and packaging process.
Datwyler Launches Ready-For-Sterilization Combiseals
RFS designed to reduce burden for drug manufacturers to prep packaging components for sterilization.
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Datwyler Healthcare. Because we care.
Datwyler Healthcare. Because we care.
