Three new cleanrooms enter operation in the US and Europe


Scapa Healthcare now operates new R&D facilities in Tennessee, New York, and Ramsbury (UK), each with a Class 7 or Class 8 cleanroom

Three new cleanrooms enter operation in the US and Europe

Scapa Healthcare, the strategic outsource partner of skin-friendly solutions for the global healthcare industry, has unveiled three new R&D Centres of Excellence. Each facility has been designed to offer full turnkey development services, extensive design and engineering expertise and the latest manufacturing technologies to help customers bring innovative products to market rapidly.

Located in Knoxville (Tennessee), Orangeburg (New York), and Ramsbury (UK), Scapa Healthcare’s R&D Centres of Excellence have a Class 7 or Class 8 cleanroom, robust quality systems and are compliant with ISO and FDA registrations for medical device manufacturing facilities.

“Each Centre features state-of-the-art manufacturing capabilities, R&D labs, specialised engineers, scientists and programme managers to drive each program from development to manufacturing to commercialisation in an efficient, controlled and expedited manner,” the company said in a statement.

The programmes, Scapa Healthcare said, are managed through a structured, lean and effective product lifecycle management process, ensuring that all products delivered to market are under full compliance.

The product development team works jointly with the customer throughout the entire process; from product design and materials selection, to prototyping and user studies, and finally to product validation, manufacturing and commercialisation.

Beyond product development, Scapa Healthcare can assist with regulatory services including building technical files, stability studies, sterilisation validation, product registration and post-market surveillance.

Commenting on the new facilities, Mike Muchin, VP of product development at Scapa Healthcare, said: “We recognise that speed to market is critical in our industry, so we have made significant investments in technology, capabilities and personnel to help our customers bring products rapidly into the global healthcare market."

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He continued: “Seamlessly working side by side with our customers, even those with manufacturing capabilities, we ensure that their products are collaboratively developed and commercialized quickly and efficiently. By leveraging our development and manufacturing expertise, they can focus their efforts on marketing and commercialization of their products.”