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Datwyler celebrates official opening of its new production plant with First Line standard in Middletown, Del

• The new facility in Middletown, Del., is Datwyler’s third facility with First Line standard which will be catering to the markets in North and South America
• Approximately 120 jobs will be created, with the majority staffed from the local community
• With the Middletown facility, Datwyler will be able to increase its global First Line production by 50 percent by 2020
• First Line is specially designed to manufacture biotech and pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment

Yesterday, Datwyler, a leading supplier of customized sealing solutions to global biotech and pharmaceutical markets, celebrated the official opening and start of production of its new facility with First Line standard in Middletown, Delaware. With this new plant, Datwyler further strengthens its position in the U.S. pharmaceutical market – the largest pharma market worldwide. The local presence enables Datwyler to optimize its supply chain and provide customers in the region with locally produced components of the highest quality, while simultaneously ensuring business continuity. The official opening ceremony was held yesterday, in the presence of high-ranking guests such as the mayor of Middletown, members of the city council, and Datwyler’s Board of Directors. The event was also open to customers and partners who showed great interest in joining the festivities.

With the start of First Line production in Middletown, Datwyler further expands its presence and resources in the largest pharmaceutical market worldwide. First Line is Datwyler’s most advanced state-of-the-art manufacturing concept for high-quality elastomer components for the fast-growing global biotech and pharmaceutical markets. With the latest addition in Middletown, Delaware, Datwyler will be able to increase its global First Line production by 50 percent by 2020. Datwyler’s two other facilities with First Line standard are located in Alken, Belgium, and Pune, India, enabling the company to cater to all major healthcare markets in Europe, the Asia Pacific region, and the Americas.

First Line Middletown: cutting-edge technology and highest level of automation
The construction of the Middletown facility started in December 2016. Since then, Datwyler invested more than $100 million in building the industry’s most advanced production facility of its kind in the United States. The new site will provide jobs for approximately 120 employees. Based on the company’s belief in hiring locally, the majority of these jobs have been staffed with members from the local community. The facility will be fully operational by the end of this year, with first samples to be expected in Q4 of 2018.

In Middletown, Datwyler has taken cleanroom production to the next level and set new standards. The facility features cutting-edge production technologies and top-of-the-line equipment. Since human interaction can bear risks of contamination, Datwyler is constantly working towards increasing the degree of automation within the cleanroom. Therefore, the individual production lines in the cleanroom are specially designed to run predominantly along the most advanced, fully automated processes. Middletown currently features the highest level of automation within the cleanroom environment out of all of Datwyler’s First Line aligned facilities.

The Middletown visitor center
To reduce the risk of bio-contamination through human interaction even further, Datwyler only allows few authorized personnel to enter the cleanroom environment. However, to give customers and partners the opportunity to observe the production without having to enter the cleanroom, Datwyler built an entire visitor center adjacent to the production facility. From there, visitors can learn more about the First Line concept and the individual production steps, observe the production process, and experience the uniqueness of this manufacturing approach.

Highest manufacturing standard: First Line
Datwyler offers best-in-class packaging solutions for the pharmaceutical and biotech markets. To ensure patient safety, the priority is to deliver safe and effective sealing solutions for drug packaging. First Line is specially designed to manufacture pharmaceutical rubber components for high-end pharmaceutical and biotech markets in a fully integrated cleanroom environment. The First Line manufacturing concept is based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection, and a unique validated washing process. Furthermore, a zoning concept is implemented. Each zone has been meticulously designed and constructed in order to prevent bio-contamination and is equipped with material and personnel airlocks. The process flow, gowning protocols, personnel and material flow, as well as automation processes all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry. All facilities aligned with the First Line manufacturing standard are specially designed and operated under a zero-defect philosophy. This innovative approach to manufacturing exceeds the most stringent quality standards of the European and U.S. regulatory authorities and is certified to ISO 15378.


The Datwyler Group is an international supplier of state-of-the-art industrial components with leading positions in global and regional market segments. As technological leader, the Datwyler Group delivers added value to its customers in all markets served. Datwyler Sealing Solutions provides customized sealing solutions to manufacturers and companies which operate in the health care and automotive industry, as well as the market segments civil engineering and consumer goods. Within the health care division, Datwyler Sealing Solutions develops, designs and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment of tomorrow. The company develops complex and unique coatings and rubber compounds enabling customers to fill syringes with medicine and thus gives numerous people across the globe access to new medications. The products and services of Datwyler Sealing Solutions are built on highquality material, innovative technologies, outstanding engineering and process know-how. With a global manufacturing footprint on three continents, sales in over 100 countries and more than 7,000 employees, the Datwyler Group generates an annual revenue of approximately US-$1.3 million. Looking back onto more than 100 years of history, Datwyler is a reliable partner, now and in the future!


Datwyler Sealing Solutions
Simone Ramser
Vice President Communications
+41 41 875 1410

bcw (burson cohn & wolve)
Katarina Horst
+49 69 238 0919

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