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A Semi-Continuous Operations Model For Solid-Dose Manufacturing
Contributor(s): Pazhayattil, Ajay Babu, Sayeed-Desta, Naheed
This article will explore the evolving generic drug environment in the U.S. It will also describe an operations model for semi-continuous manufacturing of generic solid-dose products that will improve flexibility and enable just-in-time production.
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Breaking Through Barriers to Continuous Manufacturing
Contributor(s): Markarian, Jennifer
Pharmaceutical manufacturing is inching towards implementing more efficient and sustainable processes, including continuous manufacturing (CM) of solid-dosage drugs. Advantages of CM include the potential for faster development, easier technical transfer, and more efficient and flexible...
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Continuous manufacturing: A changing processing paradigm
Contributor(s): Randi Hernandez
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Designing a novel continuous manufacturing plant with superior monitoring and control
Contributor(s): Singh, Ravendra, Zhang, Jun Ierapetritou, Marianthi, Ramachandran, Rohit
There is a growing interest in manufacturing the pharmaceutical product continuously . Along with other advantages , it provides an appropriate platform to implement suitable monitoring and control architecture, to improve the product quality and minimise product rejection and operating expenses....
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment
Contributor(s): Muzzio, Fernando, Singh, M Sebastian Escotet-Espinoza Ravendra, Lee Sau, Thomas O’Connor Marianthi, Ierapetritou, Lee Sharmista Chatterjee Rohit Ramachandran, Sen, Maitraye
The pharmaceutical industry has recognized the value of implementing a systematic approach to drug product development where quality is built into the product and process. The FDA initiative on quality by design (QbD) promotes the design of the product and manufacturing process using principles...
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Holistic Control Strategies for Continuous Manufacturing
Contributor(s): Moore, Christine, Garcia, Thomas, Hausner, Douglas B., Ben-Anat, Inna
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations....
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Model-predictive design, control and optimization of pharmaceutical process
Contributor(s): Muzzio, F, Singh, R Chaudhury, A Rogers, A Ramachandran, R, Ierapetritou, M
Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process. Currently, there is a high level of interest in the pharmaceutical industry in continuous-manufacturing strategies, integrated with online-monitoring tools, that are...
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Model-Predictive Design, Control, and Optimization
Contributor(s): Muzzio, Fernando, Singh, Ravendra Chaudhury, Anwesha Rogers, Amanda Ramachandran, Rohit, Ierapetritou, Marianthi
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Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Magazine | Contributor(s): Gabriella Dahlgren, Kevin A. Macias, Antonio R. Moreira, Duncan R. Thompson, Christoph Herwig, Robert Dream
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
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Five key factors to consider when selecting a granulation system for tablet manufacturing
Magazine | Contributor(s): Fi Forrest
Granulation is a vital process in pharmaceutical dosage forms, transforming powders into granules. Michael Schupp from Gerteis - specialists in dry granulation systems for the pharmaceutical industry - discusses what you should be looking for when choosing your granulation method.