Millstone Medical Outsourcing said today that it has broken ground on a 5,000-square-foot cleanroom facility expansion at its Fall River, Massachusetts headquarters.

The project is Millstone’s third cleanroom expansion. The additional Class 10,000/ISO7-rated cleanroom space is for medical device packaging operations. It will bring the company’s total cleanroom footprint to 20,000 square feet.

Responding to increased market demands

Millstone Medical Outsourcing officials say they’ve seen increased demand for cleanroom packaging and assembly services with expert support. The need to comply with the new European Union Medical Device Regulation (EU MDR) has been a significant driver. According to the company, the MDR has increased the need to convert products from non-sterile to sterile packaging.

“Throughout its history, Millstone has been strategic about staying ahead of customer growth and evolving needs with the addition of capacity before it’s truly needed. This expansion triples our original cleanroom facility space to enable us to continue to serve existing and new customers with cleanroom packaging and assembly,” Millstone GM Tom Williams said in a news release.

In 2020, Millstone Medical Outsourcing completed a major 60,000-square-foot expansion in Fall River. The previous expansion boosted total production space to 124,000 square feet. In addition, its workforce grew to 500 employees in late 2018, reaching 600 by February 2021.

“Millstone has always been a high-growth company,” said CEO Karl Neuberger. “This year has ushered in an exciting new pace of rapid growth, and the expansion of our cleanroom facility is key to Millstone’s continued position at the very forefront of firms delivering expert post-manufacturing and aftermarket services for the world’s largest manufacturers. With more space and our on-staff expertise, we can continue to support our customers in navigating the needs and changes of the marketplace for years to come.”