Ash Stevens Inc. (ASI), a full service contract pharmaceutical manufacturer, is in the final stages of completing a multi-year, multi-million dollar expansion to its cGMP manufacturing facility in Riverview, Michigan. All construction on the project is now complete. The final phase of the expansion involves the commissioning and validation of a new large-scale reactor bay and companion large-scale isolation bay. Validation activities are scheduled to be complete April 2013. The new large-scale reactor bay houses 2,000, 3,000 and 4,000 liter glass-lined vessels equipped with split butterfly valves and appropriate engineering controls for potent compound charging and handling. The new adjacent isolation bay is equipped with a 1.5 m2 fixed filter dryer with glovebox technology for contained isolation, drying, and packaging of large-scale batches. This technology permits handling of potent compounds and air sensitive materials at scale.
“With the completion of the expansion, Ash Stevens will have the capability to meet the service and capacity needs of most projects while still providing close interactive client support and project management to facilitate a successful outsourcing experience. We have come a long way over the past fifty years and are very excited to be completing this latest phase of expansion at our state-of-the-art manufacturing facility in Riverview, Michigan,” says Dr. Stephen Munk, President and CEO of Ash Stevens.
In addition to the large-scale reactor and isolation bays, Ash Stevens has added many other upgrades to its Riverview manufacturing facility since beginning this expansion phase in 2006. These upgrades include: a new hydrogenation reactor bay; a new solid-state characterization laboratory that includes DSC, TGA, XRPD and PSD instrumentation; a new laboratory with appropriate air handling systems for the synthesis of highly potent compounds; a new state-of-the-art materials storage and handling facility; new Rosenmund filter dryers with glovebox technology; and a new safety and hazard assessment laboratory equipped with RC1 technology.