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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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Opportunities for Process Control and Quality Assurance Using Online NIR Analysis to a Continuous Wet Granulation Tableting Line
09 Jun 2023 | Contributor(s):: Palmer J., O’Malley C.J., Wade M.J., Martin E.B., Page T., Montague G.A.
This paper investigates the application of online near-infrared measurements as a means to measure blend uniformity in a continuous tableting line. Underlying all the monitoring and control methods is the ability to measure key tablet properties online at a rate suitable for control purposes. The...
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Model-based computer-aided framework for design of process monitoring and analysis systems
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Gernaey, Krist V, Gani, Rafiqul
In the manufacturing industry, for example, the pharmaceutical industry, a thorough understanding of the process is necessary in addition to a properly designed monitoring and analysis system (PAT system) to consistently obtain the desired end-product properties....
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Inline monitoring and a PAT strategy for pharmaceutical hot-melt extrusion
09 Jun 2023 | Contributor(s):: Wahl, PR, Treffer, DMohr, S, Roblegg, E, Koscher, G, Khinast, JG
Implementation of continuous manufacturing in the pharmaceutical industry requires tight process control. This study focuses on a PAT strategy for hot melt extrusion of vegetable calcium stearate (CaSt) as matrix carrier and paracetamol as active pharmaceutical ingredient (API). The extrusion was...
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ICAS-PAT: A software for design, analysis and validation of PAT systems
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Gernaey, Krist V, Gani, Rafiqul
In chemicals based product manufacturing, as in pharmaceutical, food and agrochemical industries, efficient and consistent process monitoring and analysis systems (PAT systems) have a very important role. These PAT systems ensure that the chemicals based product is manufactured with the specified...
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Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples
09 Jun 2023 | Contributor(s):: Ooi, Shing Minga, Sarkar, Srimantaa, Van Varenbergh, Grietb, Schoeters, Krisb, Heng, Paul Wan Sia
Continuous processing and production in pharmaceutical manufacturing has received increased attention in recent years mainly due to the industries’ pressing needs for more efficient, cost-effective processes and production, as well as regulatory facilitation. To achieve optimum product quality,...
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3D printing and continuous flow chemistry technology to advance pharmaceutical manufacturing in developing countries
09 Jun 2023 | Contributor(s):: Sagandira, CR, Siyawamwaya, M, Watts, P
The realization of a downward spiralling of diseases in developing countries requires them to become self-sufficient in pharmaceutical products. One of the ways to meet this need is by boosting the local production of active pharmaceutical ingredients and embracing enabling technologies. Both 3D...