Our ‘dynamic flowsheet model’ links API purification and processing with downstream tablet manufacturing to provide better control of the process variables and, ultimately, the critical quality attributes of the final pharmaceutical product. Here’s how.
The advantages of continuous processing schemes have been discussed by many in the industry (1-3), but the US FDA’s stringent regulatory guidelines have somewhat hindered implementation. Despite this, progress is being made and the pharma industry is slowly moving from batch to continuous processing. As a result, it is necessary to have a clear understanding of the process dynamics and to develop suitable tools to help with the process design analysis. We believe that modeling and simulation can aid the transition.
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