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Using PAT to accelerate the transition to continuous API manufacturing
09 Jun 2023 | Contributor(s):: Gouveia, Francisca, Rahbek, Jesper, Mortensen, Asmus, Pedersen, Mette, Felizardo, Pedro, Bro, Rasmus, Mealy, Michael
Significant improvements can be realized by converting conventional batch processes into continuous ones. The main drivers include reduction of cost and waste, increased safety, and simpler scale-up and tech transfer activities. Redesigning the process layout offers the opportunity to incorporate...
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Simplified formulations with high drug loads for continuous twin-screw granulation
09 Jun 2023 | Contributor(s):: Meier, R., Thommes, M., Rasenack, N., Krumme, M., Moll, K. -P., Kleinebudde, P.
As different batches of the same excipients will be intermixed during continuous processes, the traceability of batches is complicated. Simplified formulations may help to reduce problems related to batch intermixing and traceability. Twin-screw granulation with subsequent tableting was used to...
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Multivariate monitoring for the industrialisation of a continuous wet granulation tableting process
09 Jun 2023 | Contributor(s):: Zomer, Simeone, Zhang, Jun, Talwar, Sameer, Chattoraj, Sayantan, Hewitt, Christopher
The pharmaceutical industry is undergoing a significant change in product development and manufacturing strategies with the progressive shift from batch to continuous processes. These typically feature vast volumes of data generated by the numerous sensors connected to several unit operations...
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Nanofiltration-Enabled InSitu Solvent and Reagent Recycle for Sustainable Continuous-Flow Synthesis
09 Jun 2023 | Contributor(s):: Fodi, T, Didaskalou, CKupai, J, Balogh, GT, Huszthy, P, Szekely, G
Solvent usage in the pharmaceutical sector accounts for as much as 90% of the overall mass during manufacturing processes. Consequently, solvent consumption poses significant costs and environmental burdens. Continuous processing, in particular continuous-flow reactors, have great potential for...
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Flexible automation with compact NMR spectroscopy for continuous production of pharmaceuticals
09 Jun 2023 | Contributor(s):: Kern, Simon, Wander, Lukas, Meyer, Klas, Guhl, Svetlana, Gottu Mukkula, Anwesh, Holtkamp, Manuel, Salge, Malte, Fleischer, Christoph, Weber, Nils, King, Rudibert, Engell, Sebastian, Paul, Andrea, Pereira Remelhe, Manuel, Maiwald, Michael
Modular plants using intensified continuous processes represent an appealing concept for the production of pharmaceuticals. It can improve quality, safety, sustainability, and profitability compared to batch processes; besides, it enables plug-and-produce / reconfiguration for fast product...
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Continuous twin screw wet granulation: The combined effect of process parameters on residence time, particle size, and granule morphology
09 Jun 2023 | Contributor(s):: Shirazian, Saeed, Zeglinski, Jacek, Darwish, Shaza, Kuhs, Manuel, Albadarin, Ahmad B., Croker, Denise M., Walker, Gavin M.
In this study, a set of 24 experiments was designed to understand the combined effect of different process parameters, i.e. material feed rate, liquid-to-solid (L/S) ratio, screw speed, and screw configuration on the residence time distribution, granule morphology, and particle size distribution...
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Asymmetric distribution in twin screw granulation
09 Jun 2023 | Contributor(s):: Seem, Tim Chan, Rowson, Neil A., Gabbott, Ian, de Matas, Marcel, Reynolds, Gavin K., Ingram, Andy
Positron Emission Particle Tracking (PEPT) was successfully employed to validate measured transverse asymmetry in material distribution in the conveying zones of a Twin Screw Granulator (TSG). Flow asymmetry was established to be a property of the granulator geometry and dependent on fill level....
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Active pharmaceutical ingredient (API) production involving continuous processes - A process systems engineering (PSE)-assisted design framework
09 Jun 2023 | Contributor(s):: Cervera-Padrell, AE, Skovby, TKiil, S, Gani, R, Gernaey, KV
A systematic framework is proposed for the design of continuous pharmaceutical manufacturing processes. Specifically, the design framework focuses on organic chemistry based, active pharmaceutical ingredient (API) synthetic processes, but could potentially be extended to biocatalytic and...