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Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing
Author: Ravendra Singh
Publisher: Elsevier
Total Pages: 700
Release: 2018-03-16
Genre: Technology & Engineering
ISBN: 0444639667

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Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing


Process Systems Engineering of Continuous Pharmaceutical Manufacturing

Process Systems Engineering of Continuous Pharmaceutical Manufacturing
Author: Matthew J. Abel
Publisher:
Total Pages: 299
Release: 2009
Genre:
ISBN:

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(Cont.) This reduction in equipment size translates to capital cost (CAPEX) savings for both the continuous process equipment and manufacturing facilities. The steady state operation of continuous processing also reduces the labor requirements and gives the continuous processes an operating cost (OPEX) advantage over batch processes. This research has contributed to the understanding of continuous pharmaceutical powder blending and quantified some of the benefits of continuous downstream pharmaceutical manufacturing. This work is being continued by the Novartis-MIT Center for Continuous Manufacturing whose work is providing the foundation for future industrial scale pharmaceutical continuous manufacturing systems.


Process Systems Engineering Methods for the Development of Continuous Pharmaceutical Manufacturing Processes

Process Systems Engineering Methods for the Development of Continuous Pharmaceutical Manufacturing Processes
Author: Amanda Rogers
Publisher:
Total Pages: 170
Release: 2015
Genre: Manufacturing processes
ISBN:

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The objective of this dissertation is to develop mathematical methods to assist in the development of continuous processes for the manufacture of pharmaceutical drug products. Specifically, modeling, analysis and optimization techniques will be developed in order to apply concepts from the field of process systems engineering to pharmaceutical development. These concepts, including sensitivity analysis, feasibility and flexibility analysis and optimal design under uncertainty, can contribute to the development of robust and well-understood manufacturing processes. This is consistent with the aim Quality-by-Design in the pharmaceutical process development. Throughout this dissertation, case studies related to continuous solids-based manufacturing will be used to demonstrate the role that process systems engineering can play in process development. The mathematical methods introduced in this dissertation will emphasize the use of reduced-order and surrogate models to address the unique challenges associated with modeling, analysis and optimization of solids-based processes.


Process Systems Engineering

Process Systems Engineering
Author: Edwin Zondervan
Publisher: Walter de Gruyter GmbH & Co KG
Total Pages: 494
Release: 2022-10-03
Genre: Science
ISBN: 3110705311

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Process systems engineering (PSE) is a discipline that delivers tools for guided decision-making in the development of new processes and products. Proven successful in the pharmaceutical-, food- and water sectors, it has also breached the field of energy systems. The future energy systems aim to be more efficient, cost-effective, environmentally benign, and interconnected. The design and operation is extremely challenging for decision-makers, engineers, and scientists and here lies a crucial role for the process systems engineer.


Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
Author: Peter Kleinebudde
Publisher: John Wiley & Sons
Total Pages: 645
Release: 2017-09-05
Genre: Science
ISBN: 1119001323

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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 manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.


Sterile Pharmaceutical Products

Sterile Pharmaceutical Products
Author: KennethE. Avis
Publisher: Routledge
Total Pages: 432
Release: 2018-03-29
Genre: Medical
ISBN: 1351413864

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Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.


Pharmaceutical Process Development

Pharmaceutical Process Development
Author: John Blacker
Publisher: Royal Society of Chemistry
Total Pages: 375
Release: 2011-08-17
Genre: Science
ISBN: 1849733074

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Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.


14th International Symposium on Process Systems Engineering

14th International Symposium on Process Systems Engineering
Author: Yoshiyuki Yamashita
Publisher: Elsevier
Total Pages: 2304
Release: 2022-06-24
Genre: Technology & Engineering
ISBN: 0323853668

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14th International Symposium on Process Systems Engineering, Volume 49 brings together the international community of researchers and engineers interested in computing-based methods in process engineering. The conference highlights the contributions of the PSE community towards the sustainability of modern society and is based on the 2021 event held in Tokyo, Japan, July 1-23, 2021. It contains contributions from academia and industry, establishing the core products of PSE, defining the new and changing scope of our results, and covering future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment and health) and contribute to discussions on the widening scope of PSE versus the consolidation of the core topics of PSE. Highlights how the Process Systems Engineering community contributes to the sustainability of modern society Establishes the core products of Process Systems Engineering Defines the future challenges of Process Systems Engineering


13th International Symposium on Process SystemsEngineering – PSE 2018, July 1-5 2018

13th International Symposium on Process SystemsEngineering – PSE 2018, July 1-5 2018
Author: Mario R. Eden
Publisher: Elsevier
Total Pages: 2602
Release: 2018-07-19
Genre: Technology & Engineering
ISBN: 0444642420

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Process Systems Engineering brings together the international community of researchers and engineers interested in computing-based methods in process engineering. This conference highlights the contributions of the PSE community towards the sustainability of modern society and is based on the 13th International Symposium on Process Systems Engineering PSE 2018 event held San Diego, CA, July 1-5 2018. The book contains contributions from academia and industry, establishing the core products of PSE, defining the new and changing scope of our results, and future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment and health) and contribute to discussions on the widening scope of PSE versus the consolidation of the core topics of PSE. Highlights how the Process Systems Engineering community contributes to the sustainability of modern society Establishes the core products of Process Systems Engineering Defines the future challenges of Process Systems Engineering