Medical device molder Pacific Plastics & Engineering, a contract manufacturer and custom injection molder, added another stand-alone 1000-ft² Class (7) 10,000 cleanroom within the facility’s existing footprint. The new cleanroom contains automated lines for assembly and secondary operations including pad printing, assembly, and heatstaking. This expands the company’s production line to include two Class (7) 10,000 cleanrooms, the first containing six presses, and five Class (8) 100,000 soft-walled cleanrooms. Both of the Class (7) cleanrooms represent the only hard-walled cleanrooms in the Northern California area, notes the company.

“As an OEM manufacturer, our goal is to be responsive to clients’ needs, and with a focus on medical, the new cleanroom allows us to expand our manufacturing while continuing to support our commitment to quality,” says Pacific Plastics’ CEO Stephanie Harkness.

Pacific Plastics provides complete services for a range of companies in the medical and biomedical markets, from early-stage startups to midcap and public companies. With 20 presses, the majority being Toshiba all-electric, ranging from 28-230 tons, in a total of 21,000 ft², the company provides complete contract manufacturing from single components to sterilized complex device assemblies.

“We are now FDA registered for Class II and Class III devices as of last October, and also have the latest ISO 9001:2008 certification and our ISO 13482:2003 certification,” says Harkness. “We’ve become a second-source supplier for risk mitigation for the midcap and public companies.”

Pacific Plastics & Engineering has focused on providing manufacturing and custom injection molding solutions to medical device and biotech customers since 1989. Additional capabilities include product design, tooling, assembly, packaging, and sterilization to provide turnkey solutions. —Clare Goldsberry