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Risk Considerations on Developing a Continuous Crystallization System for Carbamazepine
09 Jun 2023 | Contributor(s):: Yang, Xiaochuan, Acevedo, David, Mohammad, Adil, Pavurala, Naresh, Wu, Huiquan, Brayton, Alex L., Shaw, Ryan A., Goldman, Mark J., He, Fan, Li, Shuaili, Fisher, Robert J., O'Connor, Thomas F., Cruz, Celia N.
Continuous manufacturing (CM) is an emerging technology in the pharmaceutical manufacturing sector, and the understanding of the impact on product quality is currently evolving. As the final purification and isolation step, crystallization has a significant impact on the final physicochemical...
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Real-time assessment of critical quality attributes of a continuous granulation process
09 Jun 2023 | Contributor(s):: Fonteyne, Margot, Vercruysse, Jurgen, Díaz, Damián Córdoba, Gildemyn, Delphine, Vervaet, Chris, Remon, Jean Paul, De Beer, Thomas
There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off-line analyses in analytical laboratories,...
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Process Analytical Technology for continuous manufacturing of solid-dosage forms
09 Jun 2023 | Contributor(s):: Fonteyne, Margot;, Vercrusysse, Jurgen, De Leersnyder, Fien, Van Snick, Bernd, Vervaet, Chris, Remon, Jean, De Beer, Thomas
Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the...