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A brief review on Process Analytical Technology (PAT)
09 Jun 2023 | Contributor(s):: Mali, Akash, Jagtap, Monali, Karekar, P., Maruska, A
Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both physically...
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A Combined Feed-Forward/Feed-Back Control System for a QbD-Based Continuous Tablet Manufacturing Process
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Muzzio, Fernando J, Ierapetritou, Marianthi, Ramachandran, Rohit
Continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end product quality as desired by QbD (quality by design)-based efficient manufacturing. The precise control of the quality of the pharmaceutical...
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A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process
09 Jun 2023 | 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 Process Control Design and Risk Analysis in Continuous Pharmaceutical Solid-Dosage Manufacturing
09 Jun 2023 | Contributor(s):: Su, Qinglin, Moreno, Mariana, Giridhar, Arun, Reklaitis, Gintaras, Nagy, Zoltan
The paradigm shift in the pharmaceutical industry to continuous manufacturing, which has recently progressed from conceptual demonstration to pilot production, has stimulated the development and application of process systems engineering (PSE) tools for implementing efficient and robust control...
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A Systematic Framework for the Design and Implementation of Sensing and Control Architecture for a Continuous Pharmaceutical Manufacturing Plant
09 Jun 2023 | 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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Advanced Control of Continuous Pharmaceutical Tablet Manufacturing Processes
09 Jun 2023 | 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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Applications of Flow Chemistry in the Pharmaceutical Industry-Highlights of the Recent Patent Literature
09 Jun 2023 | Contributor(s):: Hughes, DL
Flow chemistry is playing an increasingly important role in drug discovery, chemical process development, and manufacturing in the pharmaceutical and agrichemical industries. The current review covers patents and patent applications from 2017 to 1Q 2020 for which no accompanying journal articles...
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Closed-loop feedback control of a continuous pharmaceutical tablet manufacturing process via wet granulation
09 Jun 2023 | 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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Data reconciliation in the Quality-by-Design (QbD) implementation of pharmaceutical continuous tablet manufacturing
09 Jun 2023 | Contributor(s):: Su, Qinglin, Bommireddy, Yasasvi, Shah Yash, Ganesh, Sudarshan, Moreno, Mariana, Liu, Jianfeng, Gonzalez, Marcial, Yazdanpanah, Nima, O'Connor, Thomas, Reklaitis, Gintaras V., Nagy, Zoltan K
Data provided by in situ sensors is always affected by some level of impreciseness as well as uncertainty in the measurements due to process operation disturbance or material property variance. In-process data precision and reliability should be considered when implementing active product quality...
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Development and implementation of an advanced model predictive control system into continuous pharmaceutical tablet compaction process
09 Jun 2023 | 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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Flow Chemistry, Continuous Processing, and Continuous Manufacturing: A Pharmaceutical Perspective
09 Jun 2023 | Contributor(s):: May, SA
Flow chemistry has become a vibrant area for Research Article over the past decade. This perspective is intended to capture insights on how these advances have and will continue to impact the development and commercialization of active pharmaceutical ingredients. A series of chemistry examples...
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From form to function: Crystallization of active pharmaceutical ingredients
09 Jun 2023 | Contributor(s):: Variankaval, Narayan, Cote, Aaron S., Doherty, Michael F.
In this perspective, we describe the state-of-the-art in API crystal product and process design, highlight barriers that currently prevent the production of better, cheaper crystalline products, and give our best estimate of where the field is going and should go during the next decade.
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Hybrid advanced control of flexible multipurpose continuous tablet manufacturing process via direct compaction
09 Jun 2023 | 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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Implementation of an advanced hybrid MPC–PID control system using PAT tools into a direct compaction continuous pharmaceutical tablet manufacturing pilot plan
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Sahay, Abhishek, Karry, Krizia, Muzzio, Fernando, Ierapetritou, Marianthi, Ramachandran, Rohit
It is desirable for a pharmaceutical final dosage form to be manufactured through a quality by design (QbD)-based approach rather than a quality by testing (QbT) approach. An automatic feedback control system coupled with PAT tools that is part of the QbD paradigm shift, has the potential to...
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Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet)
09 Jun 2023 | Contributor(s):: Singh, Ravendra
Real-time process control is highly desired for efficient quality by design (QbD)-based pharmaceutical manufacturing. A control system ensures the predefined end-product quality, satisfies the high regulatory constraints, facilitates real-time release of the product, and optimizes the resources....
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Loss-in-weight feeding, powder flow and electrostatic evaluation for direct compression hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing
09 Jun 2023 | Contributor(s):: Allenspach, Carl, Timmins, Peter, Lumay, Geoffroy, Holman, James, Minko, Tamara
Minimizing variability in the feeding process is important for continuous manufacturing since materials are fed individually and can impact the final product. This study demonstrates the importance of measuring powder properties and highlights the need to characterize the feeding performance both...
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Mechanistic modeling for systematic design and analysis of PAT systems
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Samad, Noor Asma Fazli Abdul Gernaey, Krist V Woodley, John M, Gani, Rafiqul
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Method for characterization of loss-in-weight feeder equipment
09 Jun 2023 | Contributor(s):: William E. Engisch, Fernando J. Muzzio
This paper presents a method for evaluating the steady state performance of loss-in-weight powder feeding equipment and then demonstrates the use of the method in evaluating the performance of a K-Tron KT35 loss-in-weight feeder for three pharmaceutical grade powders. The method describes in...
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Practical application of roller compaction process modeling
09 Jun 2023 | Contributor(s):: Reynolds, Gavin, Ingale, Rohit Roberts, Ron Kothari, Sanjeev, Gururajan, Bindhu
Very limited work has been reported on comparing the performance of the roller compaction process at different scales. The majority of the approaches highlighted in the literature discuss the applicability of using confined uniaxial compaction for predicting the performance of the roller...
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Prediction of segregation tendency occurrence in dry particulate pharmaceutical mixtures: Development of a mathematical tool adapted for granular systems application
09 Jun 2023 | Contributor(s):: Abatzoglou, N;, Simard, JS
Segregation phenomena are of importance in nearly all processes involving dry granular and powder mixtures. The extent of segregation directly influences the eventual rejection of a considerable percentage of the final product in the majority of pharmaceutical processes; among these are those...
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Process analytical technology in continuous manufacturing of a commercial pharmaceutical product
09 Jun 2023 | Contributor(s):: Vargas, Jenny, Nielsen, Sarah, Cárdenas, Vanessa, Gonzalez, Anthony, Aymat, Efrain, Almodovar, Elvin, Classe, Gustavo, Colón, Yleana, Sanchez, Eric, Romañach, Rodolfo
The implementation of process analytical technology and continuous manufacturing at an FDA approved commercial manufacturing site is described. In this direct compaction process the blends produced were monitored with a Near Infrared (NIR) spectroscopic calibration model developed with partial...
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Progress of Pharmaceutical Continuous Crystallization
09 Jun 2023 | Contributor(s):: Zhang, DJ, Xu, SJDu, SC, Wang, JK, Gong, JB
Crystallization is an important unit operation in the pharmaceutical industry. At present, most pharmaceutical crystallization processes are performed in batches. However, due to product variability from batch to batch and to the low productivity of batch crystallization, continuous...
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Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
09 Jun 2023 | Contributor(s):: Esmonde-White, Karen A, Cuellar, Maryann, Uerpmann, Carsten, Lenain, Bruno., Lewis, Ian R.
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data...
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Residence time distribution modelling and in line monitoring of drug concentration in a tablet press feed frame containing dead zones
09 Jun 2023 | Contributor(s):: Tanimura, Shinji, Singh, Ravendra Román-Ospino, Andrés D, Ierapetritou, Marianthi
The presence of a ‘significant dead zone’ in any continuous manufacturing equipment may affect the product quality and need to be investigated systematically. Dead zone will affect the residence time distribution (RTD) of continuous manufacturing and thus the mixing and product quality. Tablet...
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Surrogate-based Optimization for Pharmaceutical Manufacturing Processes
09 Jun 2023 | 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...