The construction of Datwyler Sealing Solutions’ (Altdorf, Switzerland) first U.S. facility for the production of medical-grade elastomer components has been completed in Middletown, DE. First announced in the fall of 2016, the $100 million investment is the largest in the company’s 102-year history. The plant will allow Datwyler to increase its global volume of elastomer components by 50%, said the company in a press release.
The production line is designed around the company’s First Line concept, which combines state-of-the-art cleanrooms, automated production and inspection systems and a unique washing process. Datwyler claims that it exceeds the quality system requirements of U.S. and European regulatory authorities; it is certified to ISO 15378, the international standard related to primary packaging materials for medicinal products.
Datwyler plans to employ approximately 120 people at the Middletown location. Certification will be carried out by customers during the current quarter, with series production starting in early 2019. With the existing First Line capacities in Belgium and the recently expanded First Line capacities in India, Datwyler said that it will be able to serve customers in the three most important economic regions—the United States, Europe and Asia—with locally produced First Line components.
The company’s Sealing Solutions division offers customers a range of specialized elastomer compounds and coatings that make it possible to efficiently prepare injectable drugs in modern administration systems such as prefilled syringes or pens that can be administered safely to patients, said the company.