Clean manufacturing operations at both our Connecticut and Nevada locations are designed to process implantable and highly regulated polymers. We offer a wide range of services, including contract process development, scale up and manufacturing services within these facilities.
Early stage process development for melt extrusion can involve a wide range of activities, with outcomes designed to refine process steps or screen formulations. White Rooms in Connecticut (1,000 square foot) and Nevada (1,800 square feet) are designed to support early stage activities for which full clean room operations are not required and customers can maximize investment value.
Our 900 square foot, class 100,000 cGMP clean manufacturing room in Connecticut includes quartz epoxy seamless floors, a dedicated fume and dust collection system, interlock pass through, gowning room, temperature controls of +/- 2° F, humidity controls, and a glove box for handling difficult materials. Our clean room is equipped with the latest in GMP designed extrusion equipment, highly accurate feeders, and fully integrated computer process controls and monitoring systems.