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Quality Risk Assessment and Mitigation of Pharmaceutical Continuous Manufacturing Using Flowsheet Modeling Approach
Contributor(s):: Tian, Geng;, Koolivand, Abdollah, Arden, Nilou S., Lee, Sau, O'Connor, Thomas F.
Integrated flowsheet modeling is an engineering approach that can provide a framework for understanding the impact of process dynamics on drug quality and associated risks during production, thereby facilitating the development of robust continuous processes. In this investigation, flowsheet...
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Modeling and simulation of continuous powder blending applied to a continuous direct compression process
Contributor(s):: Galbraith, Shaun C., Liu, Huolong, Cha, Bumjoon, Park, Seo-Young, Huang, Zhuangrong, Yoon, Seongkyu
Continuous manufacturing techniques are increasingly being adopted in the pharmaceutical industry and powder blending is a key operation for solid-dosage tablets. A modeling methodology involving axial and radial tanks-in-series flowsheet models is developed to describe the residence time...
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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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Dynamic flowsheet model development and sensitivity analysis of a continuous pharmaceutical tablet manufacturing process using the wet granulation route
Contributor(s):: Metta, Nirupaplava, Ghijs, Michael Schäfer, Elisabeth Kumar, Ashish Cappuyns, Philippe Van Assche, Ivo Singh, Ravendra Ramachandran, Rohit De Beer, Thomas, Ierapetritou, Marianthi
In view of growing interest and investment in continuous manufacturing, the development and utilization of mathematical model(s) of the manufacturing line is of prime importance. These models are essential for understanding the complex interplay between process-wide critical process parameters...