Datwyler, a supplier of customized sealing solutions to biotech and pharma markets, has opened a new production facility in Middletown, Delaware, US.
Datwyler provides advanced packaging solutions to the customers in the pharmaceutical and biotech markets.
The new facility is the company’s third plant with first line standard which will be catering to the markets in North and South America
First line is the firm’s advanced manufacturing concept for quality elastomer components for the global biotech and pharmaceutical markets.
The first line concept has been developed to produce pharmaceutical rubber components in a fully integrated cleanroom environment.
Datwyler started construction on Middletown facility in December 2016. Since then, the firm invested over $100m to develop the advanced production facility in the US.
Expected to be fully operational in the fourth quarter of this year, the new facility will employ around 120 people.
Datwyler’s first line concept is said to be based on advanced -modern cleanroom technology, automated production cells, fully automated camera inspection and unique validated washing process.
A zoning concept will be implemented, as part of the process. Each zone has been developed to avoid bio-contamination and is provided with material and personnel airlocks.
The facility is provided with individual production lines in the cleanroom to operate predominantly along the fully automated processes.
Datwyler’s new facility will allow few authorized personnel into the cleanroom environment to reduce the risk of bio-contamination through human interaction.
The process flow, gowning protocols, personnel and material flow, as well as automation processes will help reduce endotoxin, bioburden, particulate and defect levels.
According to the company, all facilities aligned with the first line manufacturing standard are specifically designed and operated under a zero-defect philosophy.
The new facility will help the company to enhance its supply chain and offer locally produced components to the customers in the region.
The facility will also allow the company to increase its global first line production by 50% by 2020.
The company also operates two other facilities with first line standard in Alken of Belgium and Pune of India. All facilities enable the company to serve customers across healthcare markets in Europe, the Asia Pacific region, and the Americas.