Millstone Medical Outsourcing has broken ground for a third cleanroom facility expansion at its Fall River, Mass., headquarters. The expansion will add 5,000 square feet of Class 10,000/ISO7-rated cleanroom space for medical device packaging operations, bringing Millstone’s total cleanroom footprint to 20,000 square feet.
 
Millstone’s leadership is undertaking this latest facility expansion as changing market needs have increased demand for cleanroom packaging and assembly services with expert support. European Union Medical Device Regulation (EU MDR) compliance has been a major driver in increased volume for conversion of products from non-sterile to sterile packaging, and Millstone has led the shift for many of its OEM customers. As Millstone General Manager Tom Williams explained, “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.”  
 
The latest facility expansion follows the completion of significant expansion in 2020 for its headquarters campus, which added 60,000 square feet of state-of-the-art warehouse and office space. This construction brought the campus’s total production space to 124,000 square feet. In addition, Millstone’s recent momentum took the firm to the milestone of 500 employees in late 2019—and the 600th employee in February 2021. Other notable advantages of Millstone’s facility include state-of-the-art cleanroom equipment and industry-leading water system quality.
 
“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,” said CEO Karl Neuberger. “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.”
 
Millstone Medical Outsourcing provides customized outsourcing solutions to the medical device industry with a client roster of more than 50 prominent companies in the orthopedic sector alone. The company offers advanced inspection, sterile and non-sterile packaging, loaner kit processing, and distribution services to device and product manufacturers worldwide. Millstone is privately held and maintains operations in Fall River, Mass., and Olive Branch, Miss. The company is FDA registered and ISO certified by BSI, Inc. to ISO 13485: 2016.