Abstract
The judicious use of buffering capacity is important in the development of future continuous pharmaceutical manufacturing processes. The potential benefits are investigated of using optimal-averaging level control for tanks that have buffering capacity for a section of a continuous pharmaceutical pilot plant involving two crystallizers, a combined filtration and washing stage and a buffer tank. A closed-loop dynamic model is utilized to represent the experimental operation, with the relevant model parameters and initial conditions estimated from experimental data that contained a significant disturbance and a change in setpoint of a concentration control loop. The performance of conventional proportional-integral (PI) level controllers is compared with optimal-averaging level controllers. The aim is to reduce the production of off-spec material in a tubular reactor by minimizing the variations in the outlet flow rate of its upstream buffer tank. The results show a distinct difference in behavior, with the optimal-averaging level controllers strongly outperforming the PI controllers. In general, the results stress the importance of dynamic process modeling for the design of future continuous pharmaceutical processes.
Highlights
Continuous manufacturing holds promise to improve the reliability and profitability of future pharmaceutical processes [1,2,3,4,5,6]
The presented dynamic model gives an accurate description of the closed-loop dynamic behavior of a section of a continuous pharmaceutical pilot plant involving continuous crystallization, filtration, washing and buffering of an intermediate pharmaceutical compound, at least for the studied conditions
The experimental data included a significant disturbance in the outlet flow rate of a crystallizer and a change in the setpoint of a concentration control loop around the buffer tank
Summary
Continuous manufacturing holds promise to improve the reliability and profitability of future pharmaceutical processes [1,2,3,4,5,6]. The role of process modeling is expected to increase significantly during this transition to enable improved design and operation [33,36,37,38,39,40,41,42,43]. A key ingredient in enabling the reliable operation of continuous pharmaceutical manufacturing processes is the development of automated control strategies. An appropriate design of automated control strategies around buffer tanks is of importance for the viability of continuous pharmaceutical manufacturing
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