MackMedical/Mack Molding is investing $2 million to expand its cleanroom molding and assembly capacity to handle significant growth in the medical consumables market. “While we’ve been involved in orthopedic disposables for some time, this marks our first foray into high‐volume, single‐use components for a Class III medical device,” says President Jeff Somple. “It’s a critical step that will open up a whole new market sector for us.”
To accommodate the work, Mack is building its third molding and assembly cleanroom at its headquarters plant in Arlington, Vt., which will house electric presses from The Japan Steel Works (JSW). The 3500‐sq‐ft cleanroom will be certified to meet Class 100,000 (ISO Class 8) standards. It is scheduled to be certified this month, after which Mack will begin validation runs.
Beyond the main molding and assembly area, the cleanroom will include space for part conveyance from an adjacent soft‐walled cleanroom that will house a robotically automated 500‐ton press. Servo‐controlled radio frequency and ultrasonic welding systems will be installed, as well as automated particulate, temperature and humidity monitoring.
The electric presses will include two 44‐ton vertical machines and 60‐ and 199‐ton horizontal presses. From JSW’s ‘advanced’ series, they feature a 62 micro second servo control circuit that delivers high‐speed performance with increased precision and reliable quality.
Semi‐automated equipment will be installed to support molding and assembly, which includes overmolding of extruded tubing. The presses will be vacuum‐fed by a modular bank of dryers located just outside the cleanroom.
In addition to this investment, Mack has two other Class 100,000 cleanrooms ‐‐ a molding cleanroom with six electric presses and an assembly cleanroom that is used for non‐sterile packaging of medical disposables, light sonic weld assembly, and temperature‐ and humidity controlled functional testing. There is also a 24‐hour whiteroom operation that houses four hydraulic presses dedicated to small part medical molding.