Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing
Author: Ravendra Singh,Zhihong Yuan
Publsiher: Elsevier
Total Pages: 698
Release: 2018-03-16
ISBN 10: 0444639667
ISBN 13: 9780444639660
Language: EN, FR, DE, ES & NL

Process Systems Engineering for Pharmaceutical Manufacturing Book Review:

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

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing
Author: Zoltan K Nagy,Arwa El Hagrasy,Jim Litster
Publsiher: Springer Nature
Total Pages: 541
Release: 2020-06-10
ISBN 10: 3030415244
ISBN 13: 9783030415242
Language: EN, FR, DE, ES & NL

Continuous Pharmaceutical Processing Book Review:

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.

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
Author: Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publsiher: John Wiley & Sons
Total Pages: 620
Release: 2017-09-05
ISBN 10: 1119001323
ISBN 13: 9781119001324
Language: EN, FR, DE, ES & NL

Continuous Manufacturing of Pharmaceuticals Book Review:

10.7.3 State of Control

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing
Author: P. J. Cullen,Rodolfo J. Romañach,Nicolas Abatzoglou,Chris D. Rielly
Publsiher: John Wiley & Sons
Total Pages: 512
Release: 2015-05-11
ISBN 10: 1118683455
ISBN 13: 9781118683453
Language: EN, FR, DE, ES & NL

Pharmaceutical Blending and Mixing Book Review:

Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
Author: Ajit S. Narang,Sherif I.F. Badawy
Publsiher: Academic Press
Total Pages: 890
Release: 2018-08-31
ISBN 10: 0323481035
ISBN 13: 9780323481038
Language: EN, FR, DE, ES & NL

Handbook of Pharmaceutical Wet Granulation Book Review:

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

21st European Symposium on Computer Aided Process Engineering

21st European Symposium on Computer Aided Process Engineering
Author: Anonim
Publsiher: Elsevier
Total Pages: 2082
Release: 2011-06-10
ISBN 10: 0444538968
ISBN 13: 9780444538963
Language: EN, FR, DE, ES & NL

21st European Symposium on Computer Aided Process Engineering Book Review:

The European Symposium on Computer Aided Process Engineering (ESCAPE) series presents the latest innovations and achievements of leading professionals from the industrial and academic communities. The ESCAPE series serves as a forum for engineers, scientists, researchers, managers and students to present and discuss progress being made in the area of computer aided process engineering (CAPE). European industries large and small are bringing innovations into our lives, whether in the form of new technologies to address environmental problems, new products to make our homes more comfortable and energy efficient or new therapies to improve the health and well being of European citizens. Moreover, the European Industry needs to undertake research and technological initiatives in response to humanity's "Grand Challenges," described in the declaration of Lund, namely, Global Warming, Tightening Supplies of Energy, Water and Food, Ageing Societies, Public Health, Pandemics and Security. Thus, the Technical Theme of ESCAPE 21 will be "Process Systems Approaches for Addressing Grand Challenges in Energy, Environment, Health, Bioprocessing & Nanotechnologies."

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology
Author: Dilip Parikh
Publsiher: Academic Press
Total Pages: 210
Release: 2017-04-04
ISBN 10: 0128047283
ISBN 13: 9780128047286
Language: EN, FR, DE, ES & NL

How to Optimize Fluid Bed Processing Technology Book Review:

How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation. Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques Offers troubleshooting tips and practical advice for scientists working with this technique

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
ISBN 10: 0470259809
ISBN 13: 9780470259801
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 218
Release: 2016-06-07
ISBN 10: 0128096535
ISBN 13: 9780128096536
Language: EN, FR, DE, ES & NL

How to Validate a Pharmaceutical Process Book Review:

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Safaraz K. Niazi
Publsiher: CRC Press
Total Pages: 464
Release: 2016-04-19
ISBN 10: 1420081314
ISBN 13: 9781420081312
Language: EN, FR, DE, ES & NL

Handbook of Pharmaceutical Manufacturing Formulations Book Review:

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Formulation and Analytical Development for Low-Dose Oral Drug Products

Formulation and Analytical Development for Low-Dose Oral Drug Products
Author: Jack Zheng
Publsiher: John Wiley & Sons
Total Pages: 432
Release: 2009-03-04
ISBN 10: 9780470386354
ISBN 13: 0470386355
Language: EN, FR, DE, ES & NL

Formulation and Analytical Development for Low-Dose Oral Drug Products Book Review:

There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 832
Release: 2008-04-04
ISBN 10: 9780470259825
ISBN 13: 0470259825
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

How to Integrate Quality by Efficient Design (QbED) in Product Development

How to Integrate Quality by Efficient Design (QbED) in Product Development
Author: Bhavishya Mittal
Publsiher: Academic Press
Total Pages: 274
Release: 2019-08-24
ISBN 10: 0128173041
ISBN 13: 9780128173046
Language: EN, FR, DE, ES & NL

How to Integrate Quality by Efficient Design (QbED) in Product Development Book Review:

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

The Chemical Engineer

The Chemical Engineer
Author: Anonim
Publsiher: Anonim
Total Pages: 329
Release: 1997
ISBN 10:
ISBN 13: UOM:39015040321963
Language: EN, FR, DE, ES & NL

The Chemical Engineer Book Review:

Production, Handling and Characterization of Particulate Materials

Production, Handling and Characterization of Particulate Materials
Author: Henk G. Merkus,Gabriel M.H. Meesters
Publsiher: Springer
Total Pages: 548
Release: 2015-11-26
ISBN 10: 3319209493
ISBN 13: 9783319209494
Language: EN, FR, DE, ES & NL

Production, Handling and Characterization of Particulate Materials Book Review:

This edited volume presents most techniques and methods that have been developed by material scientists, chemists, chemical engineers and physicists for the commercial production of particulate materials, ranging from the millimeter to the nanometer scale. The scope includes the physical and chemical background, experimental optimization of equipment and procedures, as well as an outlook on future methods. The books addresses issues of industrial importance such as specifications, control parameter(s), control strategy, process models, energy consumption and discusses the various techniques in relation to potential applications. In addition to the production processes, all major unit operations and characterization methods are described in this book. It differs from other books which are devoted to a single technique or a single material. Contributors to this book are acknowledged experts in their field. The aim of the book is to facilitate comparison of the different unit operations leading to optimum equipment choices for the production, handling and storage of particulate materials. An advantage of this approach is that unit operations that are common in one field of application are made accessible to other fields. The overall focus is on industrial application and the book includes some concrete examples. The book is an essential resource for students or researchers who work in collaboration with manufacturing industries or who are planning to make the switch from academia to industry.

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
Author: Igor Gorsky,Harold S. Baseman
Publsiher: Academic Press
Total Pages: 298
Release: 2019-11-27
ISBN 10: 012809446X
ISBN 13: 9780128094464
Language: EN, FR, DE, ES & NL

Principles of Parenteral Solution Validation Book Review:

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Unit Manufacturing Processes

Unit Manufacturing Processes
Author: National Research Council,Division on Engineering and Physical Sciences,Board on Manufacturing and Engineering Design,Commission on Engineering and Technical Systems,Unit Manufacturing Process Research Committee
Publsiher: National Academies Press
Total Pages: 228
Release: 1995-01-03
ISBN 10: 9780309176675
ISBN 13: 0309176670
Language: EN, FR, DE, ES & NL

Unit Manufacturing Processes Book Review:

Manufacturing, reduced to its simplest form, involves the sequencing of product forms through a number of different processes. Each individual step, known as an unit manufacturing process, can be viewed as the fundamental building block of a nation's manufacturing capability. A committee of the National Research Council has prepared a report to help define national priorities for research in unit processes. It contains an organizing framework for unit process families, criteria for determining the criticality of a process or manufacturing technology, examples of research opportunities, and a prioritized list of enabling technologies that can lead to the manufacture of products of superior quality at competitive costs. The study was performed under the sponsorship of the National Science Foundation and the Defense Department's Manufacturing Technology Program.

Pharmaceutical Dosage Forms - Tablets

Pharmaceutical Dosage Forms - Tablets
Author: Larry L. Augsburger,Stephen W. Hoag
Publsiher: CRC Press
Total Pages: 1552
Release: 2016-04-19
ISBN 10: 1420063863
ISBN 13: 9781420063868
Language: EN, FR, DE, ES & NL

Pharmaceutical Dosage Forms - Tablets Book Review:

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, an

Importing Into the United States

Importing Into the United States
Author: United States Customs Service
Publsiher: The Minerva Group, Inc.
Total Pages: 132
Release: 2002-06
ISBN 10: 9780894990779
ISBN 13: 0894990772
Language: EN, FR, DE, ES & NL

Importing Into the United States Book Review:

This publication provides an overview of the importing process and contains general information about import requirements. This edition contains much new and revised material brought about because of changes in the law, particularly the Customs Modernization Act. The Customs modernization provisions has fundamentally altered the process by shifting to the importer the legal responsibility for declaring the value, classification, and rate of duty applicable to entered merchandise.Chapters cover entry of goods, informed compliance, invoices, assessment of duty, classification and value, marking, special requirements for alcoholic beverages, motor vehicles and boats, import quotas, fraud, and foreign trade zones.In addition to the material provided by the U. S. Customs Service, the private commercial publisher of this book has provided a bonus chapter on how to build a tax-free import-export business.

Polymer Science and Engineering

Polymer Science and Engineering
Author: National Research Council,Division on Engineering and Physical Sciences,Commission on Physical Sciences, Mathematics, and Applications,Committee on Polymer Science and Engineering
Publsiher: National Academies Press
Total Pages: 192
Release: 1994-01-01
ISBN 10: 0309049989
ISBN 13: 9780309049986
Language: EN, FR, DE, ES & NL

Polymer Science and Engineering Book Review:

Polymers are used in everything from nylon stockings to commercial aircraft to artificial heart valves, and they have a key role in addressing international competitiveness and other national issues. Polymer Science and Engineering explores the universe of polymers, describing their properties and wide-ranging potential, and presents the state of the science, with a hard look at downward trends in research support. Leading experts offer findings, recommendations, and research directions. Lively vignettes provide snapshots of polymers in everyday applications. The volume includes an overview of the use of polymers in such fields as medicine and biotechnology, information and communication, housing and construction, energy and transportation, national defense, and environmental protection. The committee looks at the various classes of polymers--plastics, fibers, composites, and other materials, as well as polymers used as membranes and coatings--and how their composition and specific methods of processing result in unparalleled usefulness. The reader can also learn the science behind the technology, including efforts to model polymer synthesis after nature's methods, and breakthroughs in characterizing polymer properties needed for twenty-first-century applications. This informative volume will be important to chemists, engineers, materials scientists, researchers, industrialists, and policymakers interested in the role of polymers, as well as to science and engineering educators and students.