A Plant-Wide Dynamic Model
of a Continuous Pharmaceutical Process
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Abstract
The pharmaceutical industry has historically benefited
from high profit margins for their products, and over the years limited
efforts have been made to change the main manufacturing concept from
batch into continuous. However, over the past decade, as a result
of an increased demand for more efficient and cost-effective processes,
interest has grown in the application of continuous manufacturing
to address economical and technical issues in the pharmaceutical field.
This option is becoming more viable, particularly with the implementation
of new process analytical technology (PAT). In this paper, we present
a plant-wide mathematical model inspired by a recently developed continuous
pharmaceutical pilot plant. This model is first used to simulate a
base case that shows typical limitations in achieving simultaneously
high productivity and quality. The main critical quality attribute
considered is the purity of the final product. To alleviate the base
case limitations and improve the pilot plant performance, the effects
of several design parameters are investigated and the most critical
are identified. In addition, alternative start-up scenarios are considered
to improve the transient performance of the pilot plant, particularly
time to steady state. The environmental footprint of the pilot plant
is evaluated and shown to be low