The course covers finished product manufacturing and packaging systems in the pharmaceutical industry, concentrating on oral solid dosage forms. Process unit operations include blending, granulating, size reduction, drying, compressing, and coating for tablets, as well as blending and filling for capsules. Design and operation of packaging equipment for tablet and capsule counting, capping, security sealing, labeling, cartoning, and case packing will be covered. Approaches for develing project documentation, such as equipment specifications, purchase orders, test plans, and validation documents, will be presented. Use of computer simulation tools for system development and improvement will be discussed. A term paper project will require students to collectively design a solid dosage manufacturing and packaging facility, including the selection of processing and packaging equipment, material flow as well as the development of commissioning and qualification plans and protocols.
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