Charles Sternberg, Associate Editor11.11.22
Donatelle, a medical device contract manufacturing company, has expanded its ISO 7 (class 10,000) clean room capabilities to meet growing demand for medical device assembly and sterile packaging.
“This is a very exciting time of growth for Donatelle,” said Treasa Springett, Donatelle president. “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.”
After successfully bidding to design, develop, and assemble a new medical device slated for launch in early 2023, Donatelle commissioned the new clean room.
The new clean room features advanced automation technology for assembly, testing, welding, and packaging and labeling to provide even faster turnaround for customers. At 2,600 square feet, the new cleanroom effectively expands the contract manufacturer’s clean room facilities for Class I, Class II and Class III medical devices, and extends its high-volume production capabilities to support tens of millions more components per year.
In addition, to meet growing demand for molding capabilities, Donatelle plans to further expand its ISO 8 clean room molding capabilities next year.
“This is a very exciting time of growth for Donatelle,” said Treasa Springett, Donatelle president. “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.”
After successfully bidding to design, develop, and assemble a new medical device slated for launch in early 2023, Donatelle commissioned the new clean room.
The new clean room features advanced automation technology for assembly, testing, welding, and packaging and labeling to provide even faster turnaround for customers. At 2,600 square feet, the new cleanroom effectively expands the contract manufacturer’s clean room facilities for Class I, Class II and Class III medical devices, and extends its high-volume production capabilities to support tens of millions more components per year.
In addition, to meet growing demand for molding capabilities, Donatelle plans to further expand its ISO 8 clean room molding capabilities next year.