Risk Considerations on Developing a Continuous Crystallization System for Carbamazepine
| Autor: | Adil Mohammad, David Acevedo, Mark J. Goldman, Alexander L. Brayton, Xiaochuan Yang, Thomas F. O’Connor, Shuaili Li, Fan He, Robert J. Fisher, Huiquan Wu, Celia N. Cruz, Ryan Shaw, Naresh Pavurala |
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| Rok vydání: | 2017 |
| Předmět: |
010405 organic chemistry
business.industry Process (engineering) Computer science Process analytical technology media_common.quotation_subject Organic Chemistry 010402 general chemistry 01 natural sciences Automation 0104 chemical sciences law.invention law Pharmaceutical manufacturing Systems design Quality (business) Product (category theory) Physical and Theoretical Chemistry Crystallization Process engineering business media_common |
| Zdroj: | Organic Process Research & Development. 21:1021-1033 |
| ISSN: | 1520-586X 1083-6160 |
| DOI: | 10.1021/acs.oprd.7b00130 |
| Popis: | 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 properties of drug substance and is considered a critical process step in achieving the continuous manufacturing of drug substances. Although many publications previously focused on various innovative techniques to continuously make crystals with desired properties, engineering difficulties such as system design, automation, and integration with process analytical technology (PAT) tools have not been thoroughly discussed. Here, we focus on how to develop a continuous crystallization system, from the perspective of process engineering, and the related risk considerations on product quality. Specifically, we designed and built an automated two-stage mixed suspension mixed product removal (MSMPR) crystallization platfor... |
| Databáze: | OpenAIRE |
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