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Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
A Book

by Peter Kleinebudde,Johannes Khinast,Jukka Rantanen

  • Publisher : John Wiley & Sons
  • Release : 2017-07-14
  • Pages : 632
  • ISBN : 1119001358
  • Language : En, Es, Fr & De
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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.

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
A Book

by Preetanshu Pandey,Rahul Bharadwaj

  • Publisher : Woodhead Publishing
  • Release : 2016-09-26
  • Pages : 464
  • ISBN : 0081001800
  • Language : En, Es, Fr & De
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The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing
A Book

by Zoltan K Nagy,Arwa El Hagrasy,Jim Litster

  • Publisher : Springer Nature
  • Release : 2020-06-10
  • Pages : 541
  • ISBN : 3030415244
  • Language : En, Es, Fr & De
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Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice

by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri

  • Publisher : Academic Press
  • Release : 2016-11-08
  • Pages : 1176
  • ISBN : 0128026375
  • Language : En, Es, Fr & De
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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Cost Control and Information Systems

Cost Control and Information Systems
A Complete Guide to Effective Design and Implementation

by Pravin P. Shah

  • Publisher : New York : McGraw-Hill
  • Release : 1981
  • Pages : 575
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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The Chemical Engineer

The Chemical Engineer
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2001
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Advanced Manufacturing Systems, ICMSE 2011

Advanced Manufacturing Systems, ICMSE 2011
A Book

by Dao Guo Yang,Tian Long Gu,Huai Ying Zhou,Jian Min Zeng,Zheng Yi Jiang

  • Publisher : Trans Tech Publications Ltd
  • Release : 2011-02-21
  • Pages : 3094
  • ISBN : 3038135828
  • Language : En, Es, Fr & De
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This work brings together the latest applications of, and advances in, CAD/CAM/CAE, energy storage and energy development, mining machinery manufacturing, new energy equipment and manufacturing, cloud manufacturing and extreme manufacturing, bio-manufacturing, enterprise informationization, integrated manufacturing systems, quality monitoring and control of manufacturing processes, measurement control technologies and intelligent systems, embedded systems, etc. This broad overview of the latest advances also provides a reference source for researchers in this field.

Product Design for Manufacture and Assembly, Second Edition, Revised and Expanded

Product Design for Manufacture and Assembly, Second Edition, Revised and Expanded
A Book

by Geoffrey Boothroyd,Peter Dewhurst,Winston Anthony Knight

  • Publisher : CRC Press
  • Release : 1994
  • Pages : 540
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Presents a summary of the analytical tools used to evaluate the cost and difficulty of manufacturing and assembling proposed product designs, encouraging a continuous dialogue between designers and manufacturing engineers during the early stages of design.

23rd European Symposium on Computer Aided Process Engineering

23rd European Symposium on Computer Aided Process Engineering
A Book

by Anonim

  • Publisher : Elsevier
  • Release : 2013-06-10
  • Pages : 1088
  • ISBN : 0444632417
  • Language : En, Es, Fr & De
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Computer-aided process engineering (CAPE) plays a key design and operations role in the process industries, from the molecular scale through managing complex manufacturing sites. The research interests cover a wide range of interdisciplinary problems related to the current needs of society and industry. ESCAPE 23 brings together researchers and practitioners of computer-aided process engineering interested in modeling, simulation and optimization, synthesis and design, automation and control, and education. The proceedings present and evaluate emerging as well as established research methods and concepts, as well as industrial case studies. Contributions from the international community using computer-based methods in process engineering Reviews the latest developments in process systems engineering Emphasis on industrial and societal challenges

Dissertation Abstracts International

Dissertation Abstracts International
The sciences and engineering. B

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2001
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Material and Manufacturing Technology

Material and Manufacturing Technology
A Book

by Xie Yi,Li Mi

  • Publisher : Trans Tech Publications Ltd
  • Release : 2010-08-11
  • Pages : 1510
  • ISBN : 3038134007
  • Language : En, Es, Fr & De
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Volume is indexed by Thomson Reuters CPCI-S (WoS). This special volume comprises 287 expertly refereed papers. The main theme covered is Materials and Manufacturing Technology; the main goal being to provide an international scientific forum for the exchange of new ideas in a number of fields, and to facilitate in-depth interaction via discussions with peers from around the world. Core areas of Materials and Manufacturing Technology, and multi-disciplinary, inter-disciplinary and practical aspects are covered, making this essential reading for anyone interested in these topics.

Scientific American

Scientific American
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1895
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Thomas' Register of American Manufacturers

Thomas' Register of American Manufacturers
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2003
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Machine Design and Manufacturing Engineering III

Machine Design and Manufacturing Engineering III
A Book

by Peng Sheng Wei

  • Publisher : Trans Tech Publications Ltd
  • Release : 2014-07-28
  • Pages : 962
  • ISBN : 3038265632
  • Language : En, Es, Fr & De
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Collection of selected, peer reviewed papers from the 2014 3rd International Conference on Machine Design and Manufacturing Engineering (3rd ICMDME 2014), May 24-25, 2014, Jeju Island, South Korea. Volume is indexed by Thomson Reuters CPCI-S (WoS). The 187 papers are grouped as follows: Chapter 1: Materials Science, Chapter 2: Manufacturing, Forming and Processing Technologies, Chapter 3: Applied Mechanics and Mechanical Engineering: Experiment, Design and Simulation, Chapter 4: Testing, Detection and Monitoring Technologies, Chapter 5: Robotics, Control System and Applications, Chapter 6: Product Design, Computation and Information Technologies

Thomas Register of American Manufacturers and Thomas Register Catalog File

Thomas Register of American Manufacturers and Thomas Register Catalog File
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2003
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Vols. for 1970-71 includes manufacturers' catalogs.

Ceramic Abstracts

Ceramic Abstracts
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1998
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Package Engineering

Package Engineering
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1979-07
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering
A Book

by Gary Prager

  • Publisher : Wiley
  • Release : 2018-12-18
  • Pages : 576
  • ISBN : 0470410329
  • Language : En, Es, Fr & De
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A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.

Chemical Abstracts

Chemical Abstracts
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Achievements in Engineering Sciences

Achievements in Engineering Sciences
A Book

by Vinod Kumar,You Jin Park,Bale V. Reddy,Amanda F. Wu

  • Publisher : Trans Tech Publications Ltd
  • Release : 2014-04-28
  • Pages : 2086
  • ISBN : 3038264652
  • Language : En, Es, Fr & De
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Collection of selected, peer reviewed papers from the 2014 3rd International Conference on Manufacturing Engineering and Process (ICMEP 2013), April 10-11, 2014, Seoul, Korea. The 378 papers are grouped as follows: Chapter 1: Advanced Materials Engineering and Processing Technologies, Chapter 2: General Mechanical Engineering and Applied Mechanics, Chapter 3: Applied Thermodynamics, Heat Transfer, Energy Conversion, Chapter 4: Instrumentation, Measurement Technologies, Analysis and Methodology, Chapter 5: Electronics and Integrated Circuits, Embedded Technology and Applications, Chapter 6: Electrical Engineering and Electric Machines, Chapter 7: Power System and Energy Engineering, Its Applications, Chapter 8: Mechatronics and Robotics, Chapter 9: Control and Automation of Manufacturing, Chapter 10: Signal and Image Processing, Data Mining and Computational Mathematics, Chapter 11: Communication, Networks and Information Technologies, Chapter 12: New Technologies, Methods and Technique in Civil Engineering, Chapter 13: Traffic and Transportation, Chapter 14: Oil and Gas Engineering, Chapter 15: Product Design and Industrial Engineering