New cleanroom facility will enable the manufacture of high-quality elastomer components for use in biotech and pharmaceutical markets
Datwyler, supplier of customised sealing solutions to global biotech and pharmaceutical markets, has celebrated the official opening and start of production of its new production facility in Middletown, Delaware (US). With this latest addition, Datwyler will be able to increase its global First Line production by 50% by 2020.
The Middletown facility features a cleanroom in which Datwyler is working to increase the degree of automation. The individual production lines in the cleanroom are specially designed to predominantly run along a fully automated process. Middletown currently features the highest level of automation within the cleanroom environment out of all of Datwyler’s First Line aligned facilities.
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.
The construction of the Middletown facility started in December 2016. Since then, Datwyler has invested more than $100 million in building the production facility. The new site will provide jobs for approximately 120 employees. The facility will be fully operational by the end of this year, with first samples to be expected in Q4 of 2018.
Datwyler offers 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 modern cleanroom technology, automated production cells, fully automated camera inspection and a validated washing process. Each zone has been designed and constructed 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 low endotoxin, bioburden, particulate, and defect levels. The facilities adheres to European and US regulatory authority standards and is certified to ISO 15378.