Plastic Injection Molding Company Builds Class 8 Cleanroom for Manufacturing Sensitive Products in the USA

Building, certifying, and maintaining a controlled cleanroom environment in a manufacturing facility can be quite costly. To help clients capitalize on cleanroom manufacturing without investing that time and expense or having to send work overseas, The Rodon Group has built an ISO Class 8-capable cleanroom for its injection molding operations.

"Now more than ever, it’s imperative that we bring manufacturing back to the U.S.,” says Dave Steen, Rodon’s QC manager. "With Rodon’s state-of-the-art Class 8 cleanroom — now a Class B modular cleanroom — we can help do just that, not only for medical device, pharmaceutical, and food and beverage companies but anyone who needs a clean-environment part for secondary operations.”

The modular cleanroom utilizes an HVAC system with a HEPA filter, enabling Rodon to modify the room’s particulate level and class based on a project’s requirements. Clients can choose the cleanroom class that meets their needs and budget, ranging from Class 8 to a white space. Allowing for flexible equipment arrangement, Rodon can also scale operations up or down, fitting six to 15 injection molding presses in the room or incorporating additional work cells.

"Rodon’s cleanroom is the latest investment in reshoring manufacturing in the critical healthcare supply chain,” explains Michael Araten, company president. "Rodon has been committed to American manufacturing for almost 70 years, and our team is excited to couple our ISO 13485 certification with our cleanroom to bring advanced precision manufacturing solutions to our customers.”

The company uses FDA-grade materials and operates over 115 presses and robotic systems in its Hatfield, Pennsylvania, facility. In addition to cleanroom manufacturing, Rodon’s services range from toolmaking and mold design to high-volume custom injection molding.