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Sustainability case studies on the use of continuous manufacturing in pharmaceutical production
| Contributor(s):: Mark S. Kerr, Kevin P. Cole
Continuous processing is now commonly used in the manufacturing of fine chemicals including agrochemicals and pharmaceuticals. Datasets are now available, including some on environmental sustainability aspects, that enable more direct comparison between related batch and flow processes....
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Kirti Narsai
Kirti has 25 years’ experience in the healthcare industry and held board positions in several large organisations with Pan African interests & was a member of the African Regional...
https://cmkc.usp.org/members/1149
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Towards Continuous Primary Manufacturing Processes-Particle Design through Combined Crystallization and Particle Isolation
| Contributor(s):: Steenweg, C, Kufner, ACHabicht, J, Wohlgemuth, K
Integrated continuous manufacturing processes of active pharmaceutical ingredients (API) provide key benefits concerning product quality control, scale-up capability, and a reduced time-to-market. Thereby, the crystallization step, which is used in approximately 90% of API productions, mainly...
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Supervised Extended Iterative Optimization Technology for Estimation of Powder Compositions in Pharmaceutical Applications: Method and Lifecycle Management
| Contributor(s):: Muñoz, Salvador García, Torres, Eduardo Hernández
Further enhancements to the extended iterative optimization technology (EIOT) method are presented. These are meant to include the effects of nonchemical interferences of known origin in the EIOT parameters and to manage the lifecycle of the method in a pharmaceutical manufacturing application. A...
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Surrogate-Based Optimization of Expensive Flowsheet Modeling for Continuous Pharmaceutical Manufacturing
| Contributor(s):: Boukouvala, Fani, Ierapetritou, Marianthi G.
Simulation-based optimization is a Research Article area that is currently attracting a lot of attention in many industrial applications, where expensive simulators are used to approximate, design, and optimize real systems. Pharmaceuticals are typical examples of high-cost products which involve...
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Spray granulation for drug formulation
| Contributor(s):: Loh, Zhi Hui, Er, Dawn Z. L., Chan, Lai Wah, Liew, Celine V., Heng, Paul W. S.
Introduction: Granulation is a key unit process in the production of pharmaceutical solid dosage forms and involves the agglomeration of fine particles with the aid of a binding agent. Fluidized bed granulation, a classic example of spray granulation, is a technique of particle agglomeration...
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Simulation-Based Design of an Efficient Control System for the Continuous Purification and Processing of Active Pharmaceutical Ingredients
| Contributor(s):: Sen, M, Singh, R, Ramachandran, R
In this study, an efficient system-wide controlsystem has been designed for the integrated continuous purification and processing of the active pharmaceutical ingredient (API). The control strategy is based on the regulatory PID controller which is most widely used in the manufacturing industry...
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Robust State Estimation of Feeding-Blending Systems in Continuous Pharmaceutical Manufacturing
| Contributor(s):: Liu, Jianfeng, Su, Qinglin, Moreno, Mariana, Laird, Carl, Nagy, Zoltan, Reklaitis, Gintaras
State estimation is a fundamental part of monitoring, control, and real-time optimization in continuous pharmaceutical manufacturing. For nonlinear dynamic systems with hard constraints, moving horizon estimation (MHE) can estimate the current state by solving a well-defined optimization problem...
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Progress to Date in the Design and Operation of Continuous Crystallization Processes for Pharmaceutical Applications
| Contributor(s):: Wood, Barbara, Girard, Kevin, Polster, Christopher, Croker, Denise
Continuous crystallization has gained interest in the pharmaceutical sector as part of the drive toward thetransition from exclusive batch manufacturing to integrated continuous manufacturing in this industry. As a result, the design and operation of continuous crystallization processes for the...
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Model-Based Control-Loop Performance of a Continuous Direct Compaction Process
| Contributor(s):: Ramachandran, Rohit, Arjunan, Jeyrathan, Chaudhury, Anwesha, Ierapetritou, Marianthi G
This study is concerned with enhanced model-based control of a continuous direct compression pharmaceutical process. The control-loop performance is assessed in silico and results obtained will be incorporated into the pilot plant facility of the continuous direct compaction process at the NSF...
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Modeling of Particulate Processes for the Continuous Manufacture of Solid-Based Pharmaceutical Dosage Forms
| Contributor(s):: Rogers, Amanda J, Hashemi, Amir, Ierapetritou, Marianthi
The objective of this work is to present a review of computational tools and models for pharmaceutical processes, specifically those for the continuous manufacture of solid dosage forms. Relevant mathematical methods and simulation techniques are discussed, as is the development of process models...
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Characterization of a Modular Continuous Vacuum Screw Filter for Small-Scale Solid-Liquid Separation of Suspensions
| Contributor(s):: Steenweg, C, Seifert, AISchembecker, G, Wohlgemuth, K
A key enabler for the future success of continuous manufacturing in pharmaceutical and fine chemical production processes is the control of product quality. Since approx. 90% of all small molecular active pharmaceutical ingredients produced involve a crystallization step, a holistic view on its...
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Challenges and Opportunities in Pharmaceutical Manufacturing Modeling and Optimization
| Contributor(s):: Rogers, Amanda, Ierapetritou, Marianthi Eden, Mario R. Siirola, John D., Towler, Gavin P.
The pharmaceutical industry currently faces economic and regulatory challenges associated with process development. Process systems engineering (PSE) tools can play a role in developing robust and economically efficient manufacturing processes. However pharmaceutical companies have lagged behind...
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Application of a System Model for Continuous Manufacturing of an Active Pharmaceutical Ingredient in an Industrial Environment
| Contributor(s):: Diab, S, Bano, GChristodoulou, C, Hodnett, N, Benedetti, A, Andersson, M, Zomer, S
Purpose In pharmaceutical manufacturing, understanding and quantifying how process conditions impact product quality is pivotal to guaranteeing process profitability with sustained product yield. We describe an integrated system model for a commercial-scale continuous manufacturing process of a...
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An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms
| Contributor(s):: Sacher, Stephan, Khinast, Johannes G.
In this chapter, the main processing steps and manufacturing aspects of solid dosage forms are described and the relevant literature is reviewed. Starting with powder feeding, powder blending, granulation (dry and wet), and drying the most important unit operations to make compactable granules...
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A Hybrid MPC-PID Control System Design for the Continuous Purification and Processing of Active Pharmaceutical Ingredients
| Contributor(s):: Sen, M, Singh, R, Ramachandran, R
In this work, a hybrid MPC (model predictive control)-PID (proportional-integral-derivative) control system has been designed for the continuous purification and processing framework of active pharmaceutical ingredients (APIs). The specific unit operations associated with the purification and...
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A Digital Twin for Process Optimisation in Pharmaceutical Manufacturing
| Contributor(s):: Gerogiorgis, Dimitrios I., Castro-Rodriguez, Daniel
Organic synthesis is a critical step in producing any Active Pharmaceutical Ingredient (API): it encompasses a series of organic (mostly catalytic) reactions and separations, whose purpose is to arrive at a solution of a target molecule, which must then undergo crystallisation for purification,...
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3D printing and continuous flow chemistry technology to advance pharmaceutical manufacturing in developing countries
| 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...