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Medical Injection Molding
Experts in medical injection molding, we remain focused on delivering high-quality components for patient critical devices utilized for Medication Delivery, Surgical Eye Care, Endoscopic Treatment, Digestive Health and more.
We employ a standardized approach when investing in new equipment such as: machines, software, auxiliary equipment, robotics, etc. This further ensures we can confidently transfer a mold from one machine to another in production and match plastic variables (i.e., cavity pressure).
ISO 7 CLEAN ROOMS
Two separate, state-of-the-art facilities with more than 50,000 square feet of combined cleanroom infrastructure with press tonnages ranging from 66T to 350T. All cleanroom machines are equipped with 3-Axis robotics to enable part handling and cavity separation.
ISO 8 CLEAN ROOM
One stand-alone cleanroom with 8 medical molding machines ranging from 88T – 220T. Each ISO 8 cleanroom machine is equipped with its own 3-axis robot.
IQ/OQ/PQ Validation
Experienced Quality Engineering staff is trained on the latest IQ/OQ/PQ mold validation protocols consisting of: First Article Inspection, process DOE, Gauge R&R, CpK Analysis, etc.
ISO 13485 certification
As an ISO 13485 certified facility, we continue to deliver the internationally recognized quality standard for the design and manufacture of Medical Devices. We are also ISO 14698 compliant and conduct routine bio-burden testing throughout the facilities.
INTEGRATED ROBOTICS
Each medical molding machine is equipped with its own multi-axis robotics system. Part handling and cavity separation are achieved utilizing integrated robotics. These systems are also tied into our process monitoring system to discard product that may drift outside our molding parameters, which are establish during our rigorous mold validation.
Advanced Process Monitoring
Process Engineers are trained at Multiple RJG Master Molder Levels through their rigorous standards. Also, we routinely utilize cavity pressure sensors with process monitoring technology to achieve 100% monitoring and traceability on patient-critical-applications
