Donatelle’s 2,600-square-foot expansion offers an ISO 7 clean room environment for medical device assembly. [Image courtesy of Donatelle]
Donatelle (New Brighton, Minnesota) recently announced the opening of a new 2,600-square-foot ISO 7 clean room.
The new space expands the contract manufacturer’s clean room facilities for Class I, Class II and Class III medical devices. In addition, it extends its high-volume production capabilities to support tens of millions more components per year.
The clean room meets the growing demand for medical device assembly and sterile packaging from the company. Donatelle officials say they decided to commission the new clean room after successfully bidding to design, develop and assemble a new medical device slated for launch in early 2023.
“This is a very exciting time of growth for Donatelle,” Treasa Springett, Donatelle’s president, said in a Nov. 4 news release. “We are committed to staying ahead and abreast of industry best practices, innovations and evolving regulations – and to prudently invest in the resources to do so. We will continue to add equipment and facilities to ensure we are agile and ready to support our customers in manufacturing products that change lives.”
In addition, to meet the growing demand for molding capabilities, Donatelle plans to further expand its ISO 8 clean room molding capabilities next year.