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Scale-Up Processes by Jamal Chaouki,Rahmat Sotudeh-Gharebagh Pdf
Common scale-up methods are conventional where the blind piloting is essential. This imposes huge investment and leads to failures mostly in solid processing. However, the limitations of resources, current shortcomings, short time-to-market demand are forced companies to minimize piloting. With these situations in mind, current digitalization outlook and computational facilities, we proposed and developed a novel iterative scale up method with case studies which highly expedites the process innovation through the following key sequences:
This book will help industrial process innovators in research, development and commercial start-up to assess the risks of commercial-scale implementation and provide them with practical guidelines and methods to reduce the risks to acceptable levels. The book can also be used in co-operation with industrial R&D people and academic researchers to shape open innovation programs and in education as a reference book for process innovation courses. Offers easily accessible, step-by-step, and concise guidelines for industrial process scale-up Explains each stage of the innovation funnel: research, development, demonstration, commercial implementation for any process type and branch Based on industrial experiences and practices, which reduces the risks of commercial scale implementation of new processes to acceptable levels and reduces cost and time of process innovation Very clear, attractive layout, using text boxes that contain clarifying notes and additional information on specific topics, which makes it a quick reference of main subjects and additional information
Scale-up Methodology for Chemical Processes by Jean-Paul Euzen,Pierre Trambouze,Jean-Pierre Wauquier Pdf
Having gained considerable experience in process development at the Institut FranCais du PEtrole, the authors present a design framework, a review of the available means of investigation, and several examples illustrating their methodology of industrial process scale up. The salient feature of the book is the fact that it addresses a subject which is vital in view of its economic repercussions, yet relatively unknown in technical and scientific circles, due to the confidentiality surrounding it.Contents: 1. Main guidelines of the methodology. 2. Various types of model. 3. Pilot plants and mock-ups. 4. Experimental techniques. 5. Applications to industrial process development. 6. Conclusions. References. Index.
Scale-up in Chemical Engineering by Marko Zlokarnik Pdf
Covering the important task of the scale-up of processes from the laboratory to the production scale, this easily comprehensible and transparent book is divided into two sections. The first part details the theoretical principles, introducing the subject for readers without a profound prior knowledge of mathematics. It discusses the fundamentals of dimensional analysis, the treatment of temperature-dependent and rheological material values and scale-up where model systems or not available or only partly similar. All this is illustrated by 20 real-world examples, while 25 exercises plus solutions new to this edition practice and monitor learning. The second part presents the individual basic operations and covers the fields of mechanical, thermal, and chemical process engineering with respect to dimensional analysis and scale-up. The rules for scale-up are given and discussed for each operation. Other additions to this second edition are dimensional analysis of pelleting processes, and a historical overview of dimensional analysis and modeling, while all the chapters have been updated to take the latest literature into account. Written by a specialist with more than 40 years of experience in the industry, this book is specifically aimed at students as well as practicing engineers, chemists and process engineers already working in the field.
Biopharmaceutical Processing by Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher Pdf
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference
Process Understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA`s Food and Drug Administration. This book covers the multidisciplinary aspects required for successful process design, safety, modeling, scale-up, PAT, pilot plant implementation, plant design as well the rapidly expanding area of outsourcing. In discussing what process understanding means to different disciplines and sectors throughout a product`s life cycle, this handbook and ready reference reveals the factors important to the development and manufacture of chemicals. The book focuses on the fundamental scientific understanding necessary. for a smoother technical transfer between the disciplines, leading to more effective and effi cient process development and manufacturing. A range of case studies are used to exemplify and illustrate the main issues raised. As a result, readers will appreciate that process understanding can deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry. This book serves as an aid to meeting the stringent regulations required by the relevant authorities through demonstrable understanding of the underlying science.
Author : Mary T. am Ende,David J. am Ende Publisher : John Wiley & Sons Page : 1435 pages File Size : 52,5 Mb Release : 2019-04-08 Category : Technology & Engineering ISBN : 9781119285502
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.
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,
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.
Advances in Life Cycle Engineering for Sustainable Manufacturing Businesses by Shozo Takata,Yasushi Umeda Pdf
Life cycle engineering explores technologies for shifting industry from mass production and consumption paradigms to closed-loop manufacturing paradigms, in which required functions are provided with the minimum amount of production. This subject is discussed from various aspects: life cycle design, design for environment, reduce-reuse-recycle, life cycle assessment, and sustainable business models. This book collects papers from the 14th International CIRP Life Cycle Engineering Conference, the longest-running annual meeting in the field.
Food Processing Operations and Scale-up by Kenneth J. Valentas,J. Peter Clark,Leon Levin Pdf
Intended for students and practitioners who have a basic education in chemical engineering or food science. Contains basic information in each area and describes some of the fundamental ideas of processing development and design. Examines the food industry structure, how it works, consumer products,
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.
Chemical Projects Scale Up: How to Go from Laboratory to Commercial covers the chemical engineering steps necessary for taking a laboratory development into the commercial world. The book includes the problems associated with scale up, equipment sizing considerations, thermal characteristics associated with scale up, safety areas to consider, recycling considerations, operability reviews and economic viability. In addition to the process design aspects of commercializing the laboratory development, consideration is given to the utilization of a development in an existing plant. Explains how heat removal for exothermic reactions can be scaled up Outlines how a reactor can be sized from batch kinetic data Discusses how the plant performance of a new catalyst can be evaluated Presents how the economics of a new product/process can be developed Discusses the necessary evaluation of recycling in commercial plants
Practical Fermentation Technology by Brian McNeil,Linda Harvey Pdf
A hands-on book which begins by setting the context;- defining 'fermentation' and the possible uses of fermenters, and setting the scope for the book. It then proceeds in a methodical manner to cover the equipment for research scale fermentation labs, the different types of fermenters available, their uses and modes of operation. Once the lab is equipped, the issues of fermentation media, preservation strains and strain improvement strategies are documented, along with the use of mathematical modelling as a method for prediction and control. Broader questions such as scale-up and scale down, process monitoring and data logging and acquisition are discussed before separate chapters on animal cell culture systems and plant cell culture systems. The final chapter documents the way forward for fermenters and how they can be used for non-manufacturing purposes. A glossary of terms at the back of the book (along with a subject index) will prove invaluable for quick reference.Edited by academic consultants who have years of experience in fermentation technology, each chapter is authored by experts from both industry and academia. Industry authors come from GSK (UK), DSM (Netherlands), Eli Lilly (USA) and Broadley James (UK-USA).
