Practical Pharmaceutical Engineering

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119418844
Total Pages : 575 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Practical Pharmaceutical Engineering by : Gary Prager

Download or read book Practical Pharmaceutical Engineering written by Gary Prager and published by John Wiley & Sons. This book was released on 2018-11-28 with total page 575 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Quality (Pharmaceutical Engineering Series)

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Publisher : Butterworth-Heinemann
ISBN 13 : 9780750651134
Total Pages : 296 pages
Book Rating : 4.6/5 (511 download)

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Book Synopsis Quality (Pharmaceutical Engineering Series) by : Kate McCormick

Download or read book Quality (Pharmaceutical Engineering Series) written by Kate McCormick and published by Butterworth-Heinemann. This book was released on 2002-09-24 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership. Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry Find the answers you are looking for quickly and easily with clear indexing and referencing Reference to international standards and practice mean this book will be useful wherever you are working

Pharmaceutical Blending and Mixing

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Publisher : John Wiley & Sons
ISBN 13 : 1118682807
Total Pages : 508 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Pharmaceutical Blending and Mixing by : P. J. Cullen

Download or read book Pharmaceutical Blending and Mixing written by P. J. Cullen and published by John Wiley & Sons. This book was released on 2015-05-11 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Engineering Change Control

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Publisher : CRC Press
ISBN 13 : 9781135491185
Total Pages : 200 pages
Book Rating : 4.4/5 (911 download)

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Book Synopsis Pharmaceutical Engineering Change Control by : Simon G. Turner

Download or read book Pharmaceutical Engineering Change Control written by Simon G. Turner and published by CRC Press. This book was released on 2003-12-15 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

Good Design Practices for GMP Pharmaceutical Facilities

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Publisher : CRC Press
ISBN 13 : 1315355027
Total Pages : 674 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Good Design Practices for GMP Pharmaceutical Facilities by : Terry Jacobs

Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 674 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Validation of Pharmaceutical Processes

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Publisher : CRC Press
ISBN 13 : 1420019791
Total Pages : 762 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Validation of Pharmaceutical Processes by : James P. Agalloco

Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 1118514343
Total Pages : 432 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by : Hamid Mollah

Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-02-01 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Modern Aspects of Pharmaceutical Quality Assurance

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Publisher : Springer Nature
ISBN 13 : 9819992710
Total Pages : 525 pages
Book Rating : 4.8/5 (199 download)

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Book Synopsis Modern Aspects of Pharmaceutical Quality Assurance by : Minal Ghante

Download or read book Modern Aspects of Pharmaceutical Quality Assurance written by Minal Ghante and published by Springer Nature. This book was released on with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Handbook of Validation in Pharmaceutical Processes, Fourth Edition by : James Agalloco

Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

How to Validate a Pharmaceutical Process

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Publisher : Academic Press
ISBN 13 : 0128096535
Total Pages : 219 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis How to Validate a Pharmaceutical Process by : Steven Ostrove

Download or read book How to Validate a Pharmaceutical Process written by Steven Ostrove and published by Academic Press. This book was released on 2016-06-07 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

What Went Wrong? Pharma Tech Case Studies

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Publisher : Notion Press
ISBN 13 : 1648506593
Total Pages : 136 pages
Book Rating : 4.6/5 (485 download)

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Book Synopsis What Went Wrong? Pharma Tech Case Studies by : P G Shrotriya

Download or read book What Went Wrong? Pharma Tech Case Studies written by P G Shrotriya and published by Notion Press. This book was released on 2020-06-21 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of What Went Wrong? Pharma Tech Case Studies is to provide multidisciplinary approaches/guidelines for problem-solving capability. These case studies are based on the actual situation faced by the author in India and overseas and successfully resolved with the back-up of science and technology convincing international regulators/complainants leading to the closing of complaints. The book provides guidelines covering regulatory requirements for documentation. How do you document (format) any complaint? How to investigate a case study, using knowledge of science and technology and method of investigation? How to reproduce the complaint in-house, where ever required? It answers these various questions. The conclusion is with corrective and preventive actions required, submission of the investigation report and assignable reason to the regulatory agency/complainant, getting a response from the complainant and once satisfied, requesting them to close the complaint. Can we integrate regulatory science with other subjects of pharmaceutical sciences to learn ‘What Went Wrong? In Pharma Tech Case Study’. Important regulatory references are provided at the end.

Validation Compliance Annual

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Publisher : CRC Press
ISBN 13 : 9780824794590
Total Pages : 1114 pages
Book Rating : 4.7/5 (945 download)

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Book Synopsis Validation Compliance Annual by : International Validation Forum

Download or read book Validation Compliance Annual written by International Validation Forum and published by CRC Press. This book was released on 1995-02-17 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Pharmaceutical Computer Systems Validation

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Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Pharmaceutical Process Development

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Author :
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733074
Total Pages : 375 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Process Development by : John Blacker

Download or read book Pharmaceutical Process Development written by John Blacker and published by Royal Society of Chemistry. This book was released on 2011-08-17 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Quality by Design

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Publisher : John Wiley & Sons
ISBN 13 : 1118895223
Total Pages : 379 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-11 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Introduction to Chemical Engineering

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Publisher : John Wiley & Sons
ISBN 13 : 1119592208
Total Pages : 373 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Introduction to Chemical Engineering by : Uche P. Nnaji

Download or read book Introduction to Chemical Engineering written by Uche P. Nnaji and published by John Wiley & Sons. This book was released on 2019-09-30 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of chemical engineering is undergoing a global “renaissance,” with new processes, equipment, and sources changing literally every day. It is a dynamic, important area of study and the basis for some of the most lucrative and integral fields of science. Introduction to Chemical Engineering offers a comprehensive overview of the concept, principles and applications of chemical engineering. It explains the distinct chemical engineering knowledge which gave rise to a general-purpose technology and broadest engineering field. The book serves as a conduit between college education and the real-world chemical engineering practice. It answers many questions students and young engineers often ask which include: How is what I studied in the classroom being applied in the industrial setting? What steps do I need to take to become a professional chemical engineer? What are the career diversities in chemical engineering and the engineering knowledge required? How is chemical engineering design done in real-world? What are the chemical engineering computer tools and their applications? What are the prospects, present and future challenges of chemical engineering? And so on. It also provides the information new chemical engineering hires would need to excel and cross the critical novice engineer stage of their career. It is expected that this book will enhance students understanding and performance in the field and the development of the profession worldwide. Whether a new-hire engineer or a veteran in the field, this is a must—have volume for any chemical engineer’s library.

Pharmaceutical Production

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Author :
Publisher : IChemE
ISBN 13 : 9780852954409
Total Pages : 500 pages
Book Rating : 4.9/5 (544 download)

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Book Synopsis Pharmaceutical Production by : Bill Bennett

Download or read book Pharmaceutical Production written by Bill Bennett and published by IChemE. This book was released on 2003 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.