Scale Up of Liquid and Semisolid Manufacturing Processes

Process scale-up is an increase in batch size or production capacity, usually in response to increased product demand, concerns about high production costs, or an increased need for clinical research supplies. Conversely, scale-down is a decrease in batch size or productivity.

These problems include but are not limited to dissimilar processing equipment between one scale and another; various requirements for process control at different production scales; insufficient data about equipment performance at different production scales; the complexity of pharmaceutical processing, which may involve several very different unit operations and equipment; and variations in macroscopic and microscopic properties of formulation components and products at different production scales. Additional usually in response to decreased product demand. Pharmaceutical manufacturing scales range from the laboratory to the pilot plant to full production. The transition from one scale to another, however, is fraught with problems.

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