Development of Continuous Pharmaceutical Production Processes Supported by Process Systems Engineering Methods And Tools

Process modelling and simulation for continuous pharmaceutical manufacturing of ibuprofen

“…Batch manufacturing processes feature advantages including equipment usage versatility, flexible production planning and scheduling, and a wide range of attainable products, and have dominated the pharmaceutical industry for a number of decades; they still are considerably more preferable due to regulatory and licensing considerations and the option to quickly recall specific batches of products (Plumb, 2005). Nevertheless, they have several disadvantages: new processes are often difficult to scale up to production level due to poor heat transfer and mixing (potentially resulting in unacceptable product quality) and efficiency can be very low with high volumes of unrecovered solvent (Anderson, 2012;Gernaey et al, 2012). Batch production plants also require significant intermediate storage capacity between process stages, resulting in large inventories of feedstock organic chemicals and sensitive intermediates.…”

Plantwide design and economic evaluation of two Continuous Pharmaceutical Manufacturing (CPM) cases: Ibuprofen and artemisinin

“…Batch production processes have multiple advantages including equipment flexibility, the option to buy process vessels 'off-the-shelf', high-fidelity offline quality control and the possibility to recall specific batches. However, improvements in batch production are rare, as this is a mature technology; its limitations include large storage volume requirements, poor heat and mass transfer scaling, and inefficient solvent and energy use (Anderson, 2012;Gernaey et al, 2012). Attention is turned to Continuous Pharmaceutical Manufacturing (CPM) which has the potential to revolutionise drug production quality, safety, yields, efficiency (of equipment, energy and material use) and cost (Plumb, 2005;Roberge et al, 2008;Mascia et al, 2013).…”

Averaging Level Control to Reduce Off-Spec Material in a Continuous Pharmaceutical Pilot Plant

“…Consequently, pharmaceutical companies are interested in the potential benefits of transforming the manufacturing of pharmaceutical products from a conventional batch-wise mode of operation to continuous flow mode [35]. 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].…”