ABSTRACT

Process engineering forms the bridge between the underlying sciences of chemistry, biology, and pharmacology and manufacturing operations. The process engineer translates the basic science and technology of the process steps into a commercially feasible production process. This task includes scaling up unit operations and converting them into the sizing, specification, and selection of the production equipment systems. These systems must meet the required production capacity for the selected products, while simultaneously meeting the constraints of capital and operating costs. The process engineer must also consider current Good Manufacturing Practice (cGMP) regulations, safety, and environmental issues.