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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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A Framework for Representative Sampling for NIR Analysis – Theory of Sampling (TOS)
Contributor(s): Esbensen, Kim H, Ciurczak, Emil W., Igne, Benoît, Workman, Jr.,Jerome, Burns, Donald A., Romañach, Rodolfo J.
This chapter deals with all critical steps before near-infrared spectroscopy (NIR) analysis, irrespective of whether the total sampling error contribution is large, intermediate, or small – all cases can be treated identically, including the widespread sensor-based solutions from the...
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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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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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Cellulose Ethers for Extrusion Applications
Contributor(s): Pinto, Elanor, Duerig, Thomas
Cellulose ethers have been used for years in developing oral dosage forms via batch processes such as direct compression and wet granulation. Recent advances in continuous manufacturing have brought about innovative technologies such as hot melt extrusion, melt extrusion granulation, and...
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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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Characterization of material properties
Contributor(s): Razavi, Sonia, Oka, Sarang, Escotet-Espinoza, M. Sebastian, Wang, Yifan, Li, Tianyi, Futran Mauricio., Muzzio, Fernando
This chapter describes the importance of deepening our understanding of material properties and their effect on process performance. There are many measurement techniques to describe the complex nature of powders, some of which are provided in this chapter. Strong knowledge of multivariate...
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Continuous manufacturing of pharmaceuticals
Contributor(s): Johannes Khinast, Jukka Rantanen
A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals.As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process...
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Continuous Pharmaceutical Processing
Contributor(s): Zoltan K Nagy, Arwa El Hagrasy, Jim Litster
Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design
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Control of Batch and Continuous Crystallization Processes using Reinforcement Learning
Contributor(s): Benyahia, Brahim, Anandan, Paul Danny Rielly, Chris Türkay, Metin, Gani, Rafiqul
In crystallization processes, the control of particle size distribution, shape and purity are crucial to achieve the targeted critical quality attributes of the final drug product and meet the pharmaceutical regulatory requirements. This work presents novel optimal trajectory tracking control...