In response to growing demand by medical-device customers, PTI Engineered Plastics, Inc, Macomb, MI, is expanding its “controlled manufacturing environment.”  Scheduled for completion in Q3 ’09, the current ISO 8 (Class 100,000) manufacturing cleanroom will be increased by an additional 3,000 sq ft and will be equipped to provide full molding, assembly, secondary operations, and packaging capabilities.

 “Customer requests for cleanroom-molded and assembled components is on the rise  as companies look to eliminate contamination and additional cleaning processes from their final device assembly operations,” says Nancy Gusmano, director of quality. “The stringent and comprehensive contamination controlled methods of ISO14644, along with some of the newest technology in the industry, will meet our customers' purity challenges and help reduce their time to market.”

Parts produced by PTI for its medical-device range from bacteria testing equipment and portable inhaler devices to disposable surgical devices.