Process Development and Manufacturing Facility
Ash Stevens’ Process Development and Drug Manufacturing Facility is located in Riverview, Mich. The 28,000 sq. ft. facility houses nine chemical drug development and production laboratories, three full-scale productions areas, as well as two analytical laboratories for quality control. Projects at this facility typically involve cGMP manufacture of material for toxicological and clinical studies through commercial production after approval of the drug product.
Major production equipment includes glass-lined batch vessels (up to 500 gallons), hydrogenation and other pressure vessels, centrifugal, nutsche and Rosenmund filter-dryer equipment, and vacuum and convection tray drying ovens. Ash Stevens also has barrier isolation systems.
Major quality control equipment includes High Performance Liquid Chromatographs (HPLC-equipped with the following detectors: VWD, DAD, RI, and MS), Gas Chromatographs (GC), UV/Vis and FTIR spectrophotometers, Total Organic Carbon Analyzer, and Karl Fischer titrators. Stability chambers are maintained at ICH accelerated, intermediate, room temperature, refrigerator and freezer conditions.