Pharmaceutical Process Engineering


Pharmaceutical Process Engineering
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Pharmaceutical Process Engineering


Pharmaceutical Process Engineering
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Author : Anthony J. Hickey
language : en
Publisher: CRC Press
Release Date : 2016-03-09

Pharmaceutical Process Engineering written by Anthony J. Hickey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-03-09 with Medical categories.


With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac



Pharmaceutical Process Engineering And Scale Up Principles


Pharmaceutical Process Engineering And Scale Up Principles
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Author : Anil B. Jindal
language : en
Publisher: Springer Nature
Release Date : 2023-07-03

Pharmaceutical Process Engineering And Scale Up Principles written by Anil B. Jindal and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-07-03 with Medical categories.


The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process. The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms. Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process. Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations. Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up. Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource for those involved in the pharmaceutical industry. Only book that is dedicated to pharmaceutical process engineering and scale-up; Contain numerous case studies for easy reference; Covers solid, liquid, and advanced dosage forms.



Sterile Pharmaceutical Products


Sterile Pharmaceutical Products
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Author : KennethE. Avis
language : en
Publisher: Routledge
Release Date : 2018-03-29

Sterile Pharmaceutical Products written by KennethE. Avis and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-29 with Medical categories.


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
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Author : A. John Blacker
language : en
Publisher: Royal Society of Chemistry
Release Date : 2011

Pharmaceutical Process Development written by A. John Blacker and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical categories.


'Pharmaceutical Process Development' is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry and informs them about the breadth of the work carried out in chemical research and development departments.



Process Systems Engineering For Pharmaceutical Manufacturing


Process Systems Engineering For Pharmaceutical Manufacturing
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Author : Ravendra Singh
language : en
Publisher: Elsevier
Release Date : 2018-03-16

Process Systems Engineering For Pharmaceutical Manufacturing written by Ravendra Singh and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-16 with Technology & Engineering categories.


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



Pharmaceutical Production


Pharmaceutical Production
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Author : Bill Bennett
language : en
Publisher: IChemE
Release Date : 2003

Pharmaceutical Production written by Bill Bennett and has been published by IChemE this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Medical categories.


This title is a general introduction aimed at all those involved in the engineering stages required for the manufacturr of the active ingredient and its dosage forms.



Continuous Manufacturing Of Pharmaceuticals


Continuous Manufacturing Of Pharmaceuticals
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Author : Peter Kleinebudde
language : en
Publisher: John Wiley & Sons
Release Date : 2017-07-14

Continuous Manufacturing Of Pharmaceuticals written by Peter Kleinebudde and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-14 with Science categories.


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.



Chemical Engineering In The Pharmaceutical Industry


Chemical Engineering In The Pharmaceutical Industry
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Author : Mary T. am Ende
language : en
Publisher: John Wiley & Sons
Release Date : 2019-04-08

Chemical Engineering In The Pharmaceutical Industry written by Mary T. am Ende and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-08 with Technology & Engineering categories.


A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.



Chemical Engineering In The Pharmaceutical Industry


Chemical Engineering In The Pharmaceutical Industry
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Author : David J. am Ende
language : en
Publisher: John Wiley & Sons
Release Date : 2011-03-10

Chemical Engineering In The Pharmaceutical Industry written by David J. am Ende and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-03-10 with Technology & Engineering categories.


This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.



23 European Symposium On Computer Aided Process Engineering


23 European Symposium On Computer Aided Process Engineering
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Author : Hirokazu Sugiyama
language : en
Publisher: Elsevier Inc. Chapters
Release Date : 2013-06-10

23 European Symposium On Computer Aided Process Engineering written by Hirokazu Sugiyama and has been published by Elsevier Inc. Chapters this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-10 with Science categories.


This study presents a business model of continuous improvement in pharmaceutical production processes. The model covers the lifecycle of an improvement, i.e. opportunity identification, project execution and change implementation, with considering various pharma-specific constraints such as GMP (Good Manufacturing Practice). The model is described as so-called an activity model using IDEF0 (Integrated DEFinition type 0) in order to define activities and sub-activities in a clear and consistent manner. A roll-defining model termed RACI (responsible, accountable, consulted and informed) is uniquely combined with the IDEF0 model, for characterizing roles of various stakeholders in each improvement step. The model was developed and applied in a new sterile drug product manufacturing facility of Roche in Kaiseraugst, Switzerland. In this start-up facility, a case study was performed for reducing losses of valuable biologics drug products with a continuous and organization-wide effort.