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In the Quality-by-Design (QbD) paradigm for pharmaceutical processes, critical quality attributes (CQAs) must meet specifications for all possible realizations of critical process parameters (CPPs) within a design space. During the startup of such a process, it is desired to begin meeting CQA specifications as quickly as possible and then robustly guarantee that specifications will continue to be...
Integrated continuous manufacturing offers ample opportunities for efficient and cost-effective pharmaceutical processes. Plant-wide control is required for meeting the stringent regulatory requirements on quality attributes of products in continuous pharmaceutical manufacturing processes. This paper investigates plant-wide model predictive control (MPC) of an end-to-end continuous pharmaceutical...
Continuous manufacturing has the potential to provide substantial improvements to the manufacturing of pharmaceutical products compared to traditional batch-wise manufacturing. A key challenge is the development of effective control strategies for this new type of process. This contribution presents the experimental application of an automated plant-wide control strategy for a continuous pharmaceutical...
A semi-continuous crystallizer configuration that combines continuous seeding using a dual impinging jet with growth rate control in a stirred tank was experimentally demonstrated for the manufacture of l-asparagine monohydrate (LAM) crystals with the objective of obtaining a target flattop size distribution. The dual impinging jets combined hot and cold saturated solutions to generate highly uniform...
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