Plastikos, a custom injection molder headquartered in Erie, Pa, recently completed its medical expansion with over 17,000 square feet of additional space. The new manufacturing cell and ISO 7 cleanroom officially began supporting production in August.
Plastikos and its sister company, Micro Mold, invested $2 million in brand new medical injection molding machines, robotics, and other supporting auxiliary equipment and purchases. The Class 10,000/ISO 7 injection molding cleanroom has been designed to accommodate eight brand medical molding machines. The expansion also includes a separate ISO 7 assembly and packaging lab, as well as corresponding medical production support departments (maintenance, toolroom, quality, and general office and meeting room space).
The ISO 7 expansion consists of five injection molding machines integrated with End of Arm Tooling capabilities vision systems, and cavity pressure monitoring software. Press tonnages range from 88T to 220T. The auxiliary room is reserved for downstream assembly and secondary operations (i.e. pad printing, ultra-sonic welding, etc.).
The separate gowning area is approximately 100 square feet. Here, workers don the appropriate required cleanroom specific garments (full-length ankle-to-neck cleanroom gowns, hair nets, beard nets, boot covers, etc.) before and after they enter the cleanroom.
The Plastikos housekeeping team continually cleans the cleanroom space every day, and the company states that its actual particle counts throughout the cleanroom register significantly below the ISO 7 requirements. They meet or exceed medical device manufacturing best practices and general good manufacturing practices with respect to specific, proprietary cleanroom protocols.
