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Systematic framework for implementation of material traceability into continuous pharmaceutical tablet manufacturing process
Contributor(s):: Billups, Matthew, Singh, Ravendra
Purpose: With the applications of more advanced manufacturing technologies being applied to the pharmaceutical industry, continuous processes are at the forefront of innovation. One area that is highly desired to be systematically investigated is material traceability in continuous manufacturing...
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Surrogate-based Optimization for Pharmaceutical Manufacturing Processes
Contributor(s):: Wang, Zilong, Escotet-Espinoza, M Sebastian Singh, Ravendra, Ierapetritou, Marianthi
The development of pharmaceutical manufacturing processes has been facilitated by recent advances in the process simulation area. However, since the simulations are usually complex and the analytical expressions of the model can be unknown, it is difficult to directly apply traditional...
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PAT for pharmaceutical manufacturing process involving solid dosages forms
Contributor(s):: Román-Ospino, Andrés D, Cárdenas, Vanessa Ortega-Zuñiga, Carlos, Singh, Ravendra
This chapter summarizes important considerations to develop multivariate methods for pharmaceuticals process monitoring and quality control in solid dosages forms based on spectroscopic techniques. The stages described in each section aimed to explain relevant knowledge of the calibration...
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Modeling the effects of material properties on tablet compaction: A building block for controlling both batch and continuous pharmaceutical manufacturing processes
Contributor(s):: Escotet-Espinoza, M Sebastian, Vadodaria, Shishir Singh, Ravendra Muzzio, Fernando J, Ierapetritou, Marianthi G
As the pharmaceutical industry modernizes its manufacturing practices and incorporates more efficient processing approaches, it is important to reevaluate which process design elements affect product quality and the means to study these systems. The purpose of this work is to provide insight on a...
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Model development and prediction of particle size distribution, density and friability of a comilling operation in a continuous pharmaceutical manufacturing process
Contributor(s):: Metta, Nirupaplava, Verstraeten, Maxim Ghijs, Michael Kumar, Ashish Schafer, Elisabeth Singh, Ravendra De Beer, Thomas Nopens, Ingmar Cappuyns, Philippe, Van Assche, Ivo
The comilling process plays an important role in solid oral dosage manufacturing. In this process, the granulated products are comminuted to the required size distribution through collisions created from a rotating impeller. In addition to predicting particle size distribution, there is a need to...
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Integrated moving horizon-based dynamic real-time optimization and hybrid MPC-PID control of a direct compaction continuous tablet manufacturing process
Contributor(s):: Singh, Ravendra, Sen, Maitraye Ierapetritou, Marianthi, Ramachandran, Rohit
In this manuscript, a moving horizon-based real-time optimization (MH-RTO) has been integrated with a hybrid model predictive control (MPC) system for a continuous tablet manufacturing process for quality by design (QbD)-based efficient continuous manufacturing. In the proposed approach, the...
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Hybrid advanced control of flexible multipurpose continuous tablet manufacturing process via direct compaction
Contributor(s):: Singh, Ravendra, Ierapetritou, Marianthi, Ramachandran, Rohit
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
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ICAS-PAT: A software for design, analysis and validation of PAT systems
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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Flowsheet optimization of an integrated continuous purification-processing pharmaceutical manufacturing operation
Contributor(s):: Sen, Maitraye, Rogers, Amanda Singh, Ravendra Chaudhury, Anwesha John, Joyce Ierapetritou, Marianthi G, Ramachandran, Rohit
In this work, a continuous API purification process has been optimized using an integrated flowsheet model. The simulation is dynamic in nature and includes an API purification step (crystallization), followed by filtration, drying and mixing of the API with an excipient. For the first time, this...
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Experimental investigation and modelling of tensile strength of pharmaceutical tablets based on shear force applied by feed frame paddles
Contributor(s):: Furukawa, Ryoichi, Singh, Ravendra, Ierapetritou, Marianthi
The feed frame is an essential device used in a rotary tablet press and it improves the performance of the powder filling process into dies. However, the feed frame affects critical quality attributes such as a tensile strength and a dissolution negatively due to a shear applied to powders from...
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Effect of material properties on the residence time distribution (RTD) of a tablet press feed frame
Contributor(s):: Furukawa, Ryoichi, Singh, Ravendra, Ierapetritou, Marianthi
In continuous manufacturing (CM) of pharmaceutical tablets, the residence time distribution (RTD) of the tablet press feed frame plays an important role in ensuring the critical quality attributes (CQAs) of the final product. Knowledge of factors affecting the RTD of the feed frame is necessary...
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Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process
Contributor(s):: Bhaskar, Aparajith, Barros, Fernando N, Singh, Ravendra
In the context of continuous pharmaceutical oral dosage manufacturing, a control system is essential to ensure that the critical quality attributes (CQAs) are maintained within the regulatory constraints by mitigating variations generated in upstream operations. Such a system is essential to the...
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Control of process operations and monitoring of product qualities through generic model-based in batch cooling crystallization
Contributor(s):: Samad, Noor Asma Fazli Abdul, Singh, Ravendra Sin, Gürkan Gernaey, Krist V, Gani, Rafiqul
A generic model-based framework has been developed for crystallization processes, with applications aiming at the control of process operations and the monitoring of product quality. This generic model-based framework allows the systematic development of a wide range of crystallization models for...
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Closed-loop feedback control of a continuous pharmaceutical tablet manufacturing process via wet granulation
Contributor(s):: Singh, Ravendra, Barrasso, Dana Chaudhury, Anwesha Sen, Maitraye Ierapetritou, Marianthi Ramachandran, Rohit
The wet granulation route of tablet manufacturing in a pharmaceutical manufacturing process is very common due to its numerous processing advantages such as enhanced powder flow and decreased segregation. However, this route is still operated in batch mode with little (if any) usage of an...
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Combined feedforward/feedback control of an integrated continuous granulation process
Contributor(s):: Pereira, Glinka Cathy, Muddu, Shashank Venkat Román-Ospino, Andrés David Clancy, Don Igne, Benoit Airiau, Christian Muzzio, Fernando J Ierapetritou, Marianthi Ramachandran, Rohit, Singh, Ravendra
Continuous manufacturing offers shorter processing times and increased product quality assurance, among several other advantages. This makes it an ever-growing interest among pharmaceutical companies. A suitable efficient control system is however desired for continuous pharmaceutical...
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An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction
Contributor(s):: R Singh, M Ierapetritou, R Ramachandran
A novel manufacturing strategy based on continuous processing integrated with online monitoring tools coupled with efficient automatic feedback control system is highly desired for efficient Quality by Design (QbD) based manufacturing ofthe next generation of pharmaceutical products with optimal...
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Advanced Control of Continuous Pharmaceutical Tablet Manufacturing Processes
Contributor(s):: Singh, Ravendra, Velazquez, Carlos Sahay, Abhishek Karry, Krizia M Muzzio, Fernando J Ierapetritou, Marianthi G, Ramachandran, Rohit
A novel manufacturing strategy based on continuous processing, integrated with online/inline monitoring tools, coupled with an advanced automatic feedback control system is highly desired for efficient Quality by Design (QbD)-based manufacturing of the next generation of pharmaceutical products...
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A systematic framework to monitor mulling processes using Near Infrared spectroscopy
Contributor(s):: Wu, Suyang, Panikar, Savitha S Singh, Ravendra Zhang, Jun Glasser, Benjamin, Ramachandran, Rohit
The optimal design of sensor location and setup is essential to ensure the accuracy and precision of in-line process monitoring of water/moisture content. This manuscript presents a systematic framework of using Near Infrared (NIR) spectroscopy to monitor moisture content in an alumina mulling...
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A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process
Contributor(s):: Singh, Ravendra, Sahay, Abhishek Muzzio, Fernando Ierapetritou, Marianthi, Ramachandran, Rohit
A novel manufacturing strategy based on continuous processing integrated with online/inline monitoring tools coupled with an advanced control system is highly desired for efficient Quality by Design (QbD)-based pharmaceutical manufacturing. A control system ensures the predefined end product...
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A Systematic Framework for the Design and Implementation of Sensing and Control Architecture for a Continuous Pharmaceutical Manufacturing Plant
Contributor(s):: Singh, Ravendra, Muzzio, Fernando J Ierapetritou, Marianthi, Ramachnadran, Rohit
The continuous pharmaceutical manufacture (CPM) plant and control architecture developed earlier is currently being widely implemented in industries [1,2]. CPM indeed provides an appropriate platform to implement suitable monitoring and control architecture, to improve product quality, and to...
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A retrofit strategy to achieve “Fast, Flexible, Future (F3)” pharmaceutical production processes
Contributor(s):: Singh, Ravendra, Rozada-Sanchez, Raquel Wrate, Tim Muller, Frans Gernaey, Krist V Gani, Rafiqul, Woodley, John M
n the work reported here, a substrates adoption methodology for a series of similar substrates has been developed as part of a retrofit strategy. The objective is to achieve “fast, flexible and future” pharmaceutical production processes by adapting a generic modular process-plant template....