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.

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.

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

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.

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.

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.

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.