Dätwyler Sealing Solutions, a supplier of elastomer formulations, coatings, aluminum seals and related processing technologies to global healthcare OEMs, has announced the construction of its first U.S. facility incorporating its First Line production standard.
Located in Middletown, DE, the plant will produce elastomer components for use in injectable drug-delivery systems. The company is pouring more than $100 million into the project, the largest investment of this kind in its 102-year history.
The company’s First Line standard integrates advanced cleanroom technology, fully automated production and inspection systems and a validated washing process. “Our manufacturing standards ensure the lowest levels of endotoxin and bioburden particulates,” David Clark, Vice President of Operations Americas, told PlasticsToday . “The cleanliness level in most areas of the plant is ISO Class 7; in the cleanroom, it is ISO Class 5,” said Clark. “Dätwyler is able to guarantee the lowest available particulate levels on the market,” added CEO Torsten Maschke.
By the time the plant is fully operational in Q4 2018, it will be the company’s third facility to meet First Line criteria—the others are in Europe and India—and will complete Dätwyler’s initiative to establish a “global footprint for First Line production facilities,” said Maschke.
The 200,000-square-foot plant will produce at least two billion components annually for pharmaceutical containers and injectable drug-delivery devices by the time it reaches full capacity. The company expects to hire approximately 120 employees, most of which will be recruited locally. The facility will be equipped with mixing, compression molding, trimming, washing and coating systems. One-hundred percent vision systems and advanced automation, including at the compounding and compression molding stations, ensure the highest level of quality control.
While this is not the company’s initial entry into the U.S. market—it operates a plant in Pennsauken, NJ—it is the only facility in North America to implement the First Line standard. There is great demand in the United States for advanced production operations of this kind, according to Chief Business Officer Dan Stefanoiu. “All of our customers confirmed the need for additional suppliers in the U.S. market for the level of production that we are offering. The mid-Atlantic area is a hotbed for pharmaceutical products, and Middletown is well-positioned to serve these customers and has a pool of talented people that can support our manufacturing operations.”
Dätwyler made the announcement at Interphex 2017 in New York, where it also unveiled new branding for its healthcare-related capabilities. The new offerings—Bio Care, Pharma Care and Med Care—more clearly align the company’s expertise and services with the respective markets, Maschke explained to PlasticsToday. “We decided about a year ago to take a new approach to the market. In the past, we took an inside-out approach—This is what we sell; what do you need?—and now it’s more of an outside-in way of doing business,” said Maschke. “The Bio Care, Pharma Care and Med Care categories represent the way our customers understand the industry and are more transparent in terms of what we can offer them.”
Moreover, said Maschke, that approach underscores Dätwyler’s ambition to go beyond supplier relationships and form partnerships with the top global pharmaceutical and medical device companies in the world.
By Norbert Sparrow
Source: Plastics Today
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