Manufacturing an active pharmaceutical ingredient (API) involves a sequence of chemical and physical transformations, with different ways to execute each step. In the pharmaceutical industry, the traditional approach is to perform each operation batchwise, where each step is completed separately, and the next step waits for the preceding one to finish. The counterpart to batchwise operation is the continuous operating mode, where material flows continuously from one operation to the next. Combining both modes gives rise to a hybrid manufacturing process.
Continuous manufacturing offers several advantages that have prompted the industry to explore it over the past decades. These benefits include the use of smaller equipment, reduced in-process material storage, limited exposure to hazardous materials, and more consistent product quality. However, continuous processes have a downside: they require an initial startup period before achieving steady operation and on-specification products. During this startup phase, materials and time are consumed, and off-spec products must be discarded before nominal operation is achieved. This startup time, which depends on the process dynamics, becomes a critical...
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