Pharmaceutical Process Engineering And Scale Up Principles

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Pharmaceutical Process Engineering and Scale-up Principles

Anil B. Jindal

Author : Anil B. Jindal
Publisher : Springer Nature
Page : 226 pages
File Size : 42,6 Mb
Release : 2023-07-03
Category : Medical
ISBN : 9783031313806

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Pharmaceutical Process Engineering and Scale-up Principles by Anil B. Jindal Pdf

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.

Pharmaceutical Process Engineering

Anthony J. Hickey,David Ganderton

Author : Anthony J. Hickey,David Ganderton
Publisher : CRC Press
Page : 230 pages
File Size : 47,5 Mb
Release : 2016-03-09
Category : Medical
ISBN : 9781420084764

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Pharmaceutical Process Engineering by Anthony J. Hickey,David Ganderton Pdf

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 Scale-Up

Michael Levin

Author : Michael Levin
Publisher : CRC Press
Page : 588 pages
File Size : 48,5 Mb
Release : 2001-12-12
Category : Medical
ISBN : 9780824741969

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Pharmaceutical Process Scale-Up by Michael Levin Pdf

Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling,

Principles of Process Research and Chemical Development in the Pharmaceutical Industry

Oljan Repic

Author : Oljan Repic
Publisher : Wiley-Interscience
Page : 248 pages
File Size : 46,7 Mb
Release : 1998
Category : Medical
ISBN : UOM:39015045683698

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Principles of Process Research and Chemical Development in the Pharmaceutical Industry by Oljan Repic Pdf

This text discusses the functions of Process R&D (research and development), which involves the method of transforming a research synthetic procedure into a plant process and the key aspects of a synthesis that must be considered when scaling up a process. Topics consist of: basic principles of chemical development; techniques for the minimization of by-product impurities; criteria for cost-effective synthesis of enantiopure compounds by resolutions; asymmetric synthesis, and "chiral pool" strategy; synthesis for labeling substances with hydrogen or carbon isotopes; and last, licensing.

Pharmaceutical Process Development

A. John Blacker,Mike T. Williams,Michael T. Williams,Royal Society of Chemistry (Great Britain)

Author : A. John Blacker,Mike T. Williams,Michael T. Williams,Royal Society of Chemistry (Great Britain)
Publisher : Royal Society of Chemistry
Page : 375 pages
File Size : 44,5 Mb
Release : 2011
Category : Medical
ISBN : 9781849731461

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Pharmaceutical Process Development by A. John Blacker,Mike T. Williams,Michael T. Williams,Royal Society of Chemistry (Great Britain) Pdf

'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.

Chemical Engineering in the Pharmaceutical Industry

Mary T. am Ende,David J. am Ende

Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Page : 1435 pages
File Size : 54,6 Mb
Release : 2019-04-08
Category : Technology & Engineering
ISBN : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry by Mary T. am Ende,David J. am Ende Pdf

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.

Practical Pharmaceutical Engineering

Gary Prager

Author : Gary Prager
Publisher : John Wiley & Sons
Page : 578 pages
File Size : 53,8 Mb
Release : 2018-12-18
Category : Science
ISBN : 9780470410325

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Practical Pharmaceutical Engineering by Gary Prager Pdf

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.

Continuous Manufacturing of Pharmaceuticals

Peter Kleinebudde,Johannes Khinast,Jukka Rantanen

Author : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publisher : John Wiley & Sons
Page : 632 pages
File Size : 52,8 Mb
Release : 2017-07-14
Category : Science
ISBN : 9781119001355

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Continuous Manufacturing of Pharmaceuticals by Peter Kleinebudde,Johannes Khinast,Jukka Rantanen Pdf

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

David J. am Ende

Author : David J. am Ende
Publisher : John Wiley & Sons
Page : 1431 pages
File Size : 50,7 Mb
Release : 2011-03-10
Category : Technology & Engineering
ISBN : 9781118088104

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Chemical Engineering in the Pharmaceutical Industry by David J. am Ende Pdf

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.

Pharmaceutical Process Scale-Up, Third Edition

Michael Levin

Author : Michael Levin
Publisher : CRC Press
Page : 0 pages
File Size : 54,5 Mb
Release : 2011-02-02
Category : Medical
ISBN : 1616310014

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Pharmaceutical Process Scale-Up, Third Edition by Michael Levin Pdf

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

Chemical Engineering in the Pharmaceutical Industry

David J. am Ende,Mary T. am Ende

Author : David J. am Ende,Mary T. am Ende
Publisher : John Wiley & Sons
Page : 1172 pages
File Size : 44,8 Mb
Release : 2019-04-23
Category : Technology & Engineering
ISBN : 9781119285861

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Chemical Engineering in the Pharmaceutical Industry by David J. am Ende,Mary T. am Ende Pdf

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

Handbook of Pharmaceutical Granulation Technology

Dilip M. Parikh

Author : Dilip M. Parikh
Publisher : CRC Press
Page : 905 pages
File Size : 45,6 Mb
Release : 2021-05-11
Category : Medical
ISBN : 9781000366389

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Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf

Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Pharmaceutical Engineering: A Primer for Advanced Process Development

René Holm,Noor Al-Rifai,Ashish Kumar

Author : René Holm,Noor Al-Rifai,Ashish Kumar
Publisher : Elsevier
Page : 0 pages
File Size : 42,9 Mb
Release : 2024-10-01
Category : Technology & Engineering
ISBN : 9780443156991

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Pharmaceutical Engineering: A Primer for Advanced Process Development by René Holm,Noor Al-Rifai,Ashish Kumar Pdf

Pharmaceutical Engineering: A Primer for Advanced Process Development. Volume One: Liquid Dosage form Process Design provides a comprehensive, engineering-focused description of pharmaceutical dosage form process development and manufacturing. The set is split into two volumes where Volume One focuses on liquids and Volume Two on solids. Each volume introduces the most commonly used manufacturing processes for pharmaceutical dosage forms and addresses critical formulation and process parameters that influence drug product process performance and product quality. This is supplemented with detailed descriptions of engineering models as well as tools that can be used to support their development and verification (such as process analytical technology (PAT)) as well as the appropriate utilization of process and equipment knowledge. Typical scale-up challenges inspired by real industrial examples will be presented as well as a review of the latest correlations, theories and models that can form the basis for science-based scale-ups and transfers. Features engineering principles of pharmaceutical drug product processes Includes development and scale-up of pharmaceutical drug product processes Defines a robust process via science and engineering-based principles

Pharmaceutical Process Scale-Up, Second Edition

Michael Levin

Author : Michael Levin
Publisher : CRC Press
Page : 576 pages
File Size : 45,9 Mb
Release : 2005-10-18
Category : Medical
ISBN : 1574448765

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Pharmaceutical Process Scale-Up, Second Edition by Michael Levin Pdf

Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated reference spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up-clearly introducing readers to the theoretical concept of dimensional analysis to quantify similar processes on varying scales.

Chemical Engineering Design

Gavin Towler,Ray Sinnott

Author : Gavin Towler,Ray Sinnott
Publisher : Elsevier
Page : 1321 pages
File Size : 43,8 Mb
Release : 2012-01-25
Category : Technology & Engineering
ISBN : 9780080966601

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Chemical Engineering Design by Gavin Towler,Ray Sinnott Pdf

Chemical Engineering Design, Second Edition, deals with the application of chemical engineering principles to the design of chemical processes and equipment. Revised throughout, this edition has been specifically developed for the U.S. market. It provides the latest US codes and standards, including API, ASME and ISA design codes and ANSI standards. It contains new discussions of conceptual plant design, flowsheet development, and revamp design; extended coverage of capital cost estimation, process costing, and economics; and new chapters on equipment selection, reactor design, and solids handling processes. A rigorous pedagogy assists learning, with detailed worked examples, end of chapter exercises, plus supporting data, and Excel spreadsheet calculations, plus over 150 Patent References for downloading from the companion website. Extensive instructor resources, including 1170 lecture slides and a fully worked solutions manual are available to adopting instructors. This text is designed for chemical and biochemical engineering students (senior undergraduate year, plus appropriate for capstone design courses where taken, plus graduates) and lecturers/tutors, and professionals in industry (chemical process, biochemical, pharmaceutical, petrochemical sectors). New to this edition: Revised organization into Part I: Process Design, and Part II: Plant Design. The broad themes of Part I are flowsheet development, economic analysis, safety and environmental impact and optimization. Part II contains chapters on equipment design and selection that can be used as supplements to a lecture course or as essential references for students or practicing engineers working on design projects. New discussion of conceptual plant design, flowsheet development and revamp design Significantly increased coverage of capital cost estimation, process costing and economics New chapters on equipment selection, reactor design and solids handling processes New sections on fermentation, adsorption, membrane separations, ion exchange and chromatography Increased coverage of batch processing, food, pharmaceutical and biological processes All equipment chapters in Part II revised and updated with current information Updated throughout for latest US codes and standards, including API, ASME and ISA design codes and ANSI standards Additional worked examples and homework problems The most complete and up to date coverage of equipment selection 108 realistic commercial design projects from diverse industries A rigorous pedagogy assists learning, with detailed worked examples, end of chapter exercises, plus supporting data and Excel spreadsheet calculations plus over 150 Patent References, for downloading from the companion website Extensive instructor resources: 1170 lecture slides plus fully worked solutions manual available to adopting instructors

Pharmaceutical Process Engineering And Scale Up Principles

Pharmaceutical Process Engineering and Scale-up Principles by Anil B. Jindal Pdf

Pharmaceutical Process Engineering by Anthony J. Hickey,David Ganderton Pdf

Pharmaceutical Process Scale-Up by Michael Levin Pdf

Principles of Process Research and Chemical Development in the Pharmaceutical Industry by Oljan Repic Pdf

Pharmaceutical Process Development by A. John Blacker,Mike T. Williams,Michael T. Williams,Royal Society of Chemistry (Great Britain) Pdf

Chemical Engineering in the Pharmaceutical Industry by Mary T. am Ende,David J. am Ende Pdf

Practical Pharmaceutical Engineering by Gary Prager Pdf

Continuous Manufacturing of Pharmaceuticals by Peter Kleinebudde,Johannes Khinast,Jukka Rantanen Pdf

Chemical Engineering in the Pharmaceutical Industry by David J. am Ende Pdf

Pharmaceutical Process Scale-Up, Third Edition by Michael Levin Pdf

Chemical Engineering in the Pharmaceutical Industry by David J. am Ende,Mary T. am Ende Pdf

Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf

Pharmaceutical Engineering: A Primer for Advanced Process Development by René Holm,Noor Al-Rifai,Ashish Kumar Pdf

Pharmaceutical Process Scale-Up, Second Edition by Michael Levin Pdf

Chemical Engineering Design by Gavin Towler,Ray Sinnott Pdf

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