Download or read book Practical Pharmaceutical Engineering written by Gary Prager and published by John Wiley & Sons. This book was released on 2018-12-18 with total page 578 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.

Download or read book Pharmaceutical Engineering written by K Sambamurthy and published by New Age International. This book was released on 2007 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: It Is Well Known That The Applications Of Unit Operations Like Heat Transfer, Evaporation, Extraction, Mixing, Filtration And A Host Of Others Are Quite Common In The Pharmaceutical Industry, Be It In The Production Of Synthetic Drugs, Biological And Microbiological Products Or In The Manufacture Of Pharmaceutical Formulations. As Such Anyone Who Is To Look After These Manufacturing Operations Must Be Quite Knowledgeable With The Theoretical And Equipment Aspects Involved In The Relevant Unit Operations.Since A Major Involvement Of The Pharmacy Graduates Lies In The Numerous Manufacturing Operations Mentioned Above, It Is Very Much Necessary That The Subject Is Taught With A Pharmacy Orientation. There Is No Book So Far Which Has Achieved This. The Existing Books On Unit Operations Give Extensive Theory And Also Deal With A Lot Of Equipment Not Employed In The Pharmaceutical Industry. Due To A Lack Of A Pharmacy-Oriented Book In This Area, The Students And The Teachers Are Facing Difficulties In Many Ways.The Present Book Is The First One Of Its Kind On Pharmaceutical Engineering. The Special Features Of This Book Are As Follows: It Includes Theoretical And Equipment Aspects Relevant To Thepharmaceutical Industry And That Too To The Extent Needed For Pharmacy Graduates And Examples From Pharmaceutical Industry Are Quoted Extensively; Solutions To A Number Of Simpler Numerical Problems Are Given. At The End Of Each Chapter, A Large Number Of Questions, Both Theoretical And Numerical, Are Given. There Is Therefore No Doubt That The Book Will Be Of Great Use Not Only To The Students But Also To The Teachers In The Subject In India And Abroad As Well.

Download or read book Essentials of Pharmaceutical Engineering written by Deeliprao Derle and published by Bsp Books Pvt. Limited. This book was released on 2015-06 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book mainly aims in guiding the teachers and students, the fundamental principles of Pharmaceutical Engineering. This book helps the students in overcoming the obstacles faced by them in understanding the aspects of Pharmaceutical Engineering. Topics, which usually confuse the students, are explained along with applications to broaden their mental horizon regarding the subject. This book is meant to serve as an introductory text for undergraduate students doing Bachelor of Pharmaceutical Sciences (B. Pharm). It will also prove useful to people working in pharmaceutical and allied industries. In keeping with its initiatory approach to pharmaceutical engineering, only the important aspects of the subject have been discussed in a simple and easily comprehensible manner.

Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2011-03-10 with total page 1431 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-04-23 with total page 1172 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Sterile Pharmaceutical Products written by Kenneth E. Avis and published by CRC Press. This book was released on 1995-10-31 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.

Download or read book Pharmaceutical Engineering Change Control written by Simon G. Turner and published by CRC Press. This book was released on 2019-08-30 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.

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.

Download or read book Process Systems Engineering for Pharmaceutical Manufacturing written by Ravendra Singh and published by Elsevier. This book was released on 2018-03-16 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Packaging Technology and Engineering written by Dipak Kumar Sarkar and published by John Wiley & Sons. This book was released on 2020-09-08 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers chemistry, physics, engineering, and therapeutic aspects of packaging—universal to pharmaceutical, medical, and food applications This book covers the chemistry, physics, materials science, engineering, and therapeutic aspects of many different types of packaging materials, emphasizing throughout the applicability of various aspects of packaging science and technology. It also provides a simultaneous discussion of interrelated fields, and addresses the universal issues within these fields’ application areas. Intended as a technical reference and as a study aid, it is relevant to anyone who studies or uses packaging or packaging materials. Packaging Technology and Engineering: Pharmaceutical, Medical and Food Applications begins with an overview of the history of the topic. It then offers chapters on the methods of obtaining raw materials, the chemistry of polymeric and non-polymeric packaging materials, physico-chemical quality parameters, and the manufacturing of packaging. Other topics look at: additives, use, suppliers, safety and environmental concerns, regulation, anti-fraud activities, new trends, and the future of packaging technology. The book also features numerous problems and worked solutions to aid student comprehension. Covers packaging and packaging materials, their properties and technologies Addresses the chemical engineering, physics, and chemistry of packaging materials, and the individual requirements for food, pharmaceutical, and medical device packaging Includes current issues such as environmental concerns and sustainability, recycling and after-use, anti-counterfeiting technology, and packaging regulations and guidelines Packaging Technology and Engineering: Pharmaceutical, Medical and Food Applications will appeal to all packaging technologists, scientists, and engineers in industry, and in regulatory agencies. It is also an excellent book for advanced students studying packaging courses, within pharmacy, pharmaceutical sciences, chemical sciences, biomedical sciences, medical sciences, engineering, product design and technology, and food science/technology.

Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

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.

Download or read book Practical Manual Of Pharmaceutical Engineering written by Mrs. B. Jeevana Jyothi and published by Nirali Prakashan. This book was released on 2008-06-07 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical Process Engineering written by Anthony J. Hickey and published by CRC Press. This book was released on 2016-03-09 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pharmaceutical Engineering Drawing written by Nema R. K. and published by CBS Publishers & Distributors Pvt Limited, India. This book was released on 2019-06-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The subject matter of this book covers the entire syllabus of pharmaceutical engineering drawing courses. It discusses lettering, lines and dimensioning, sheet layout, symbols of materials, free hand sketching, construction of scales, geometrical drawing, principles of projection, first angle and third angle methods of projection, isometric views, sectional views, nuts and bolts, valves, pipe joints, rivets and riveted joints, assembly drawings, and flow diagrams.

Download or read book Introduction to Pharmacuetical Engineering written by Dr Ar Paradkar and published by Editora Record. This book was released on 2010-08 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction - Flow of Fluids - Heat Transfer - Mass Transfer - Size Reduction - Size Separation - Filtration - Mixing - Extraction - Crystallization - Evaporation - Drying - Distillation - Pumps - Transportation of Solids - Corrosion - Fire Hazards - Pollution From Pharmaceutical Industry - Conversion Tables - Index