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Author: Jamal Chaouki Publisher: Walter de Gruyter GmbH & Co KG ISBN: 3110713985 Category : Technology & Engineering Languages : en Pages : 350
Book Description
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:
Author: Jamal Chaouki Publisher: Walter de Gruyter GmbH & Co KG ISBN: 3110713985 Category : Technology & Engineering Languages : en Pages : 350
Book Description
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:
Author: Jan Harmsen Publisher: Elsevier ISBN: 0444627391 Category : Technology & Engineering Languages : en Pages : 112
Book Description
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
Author: Jean-Paul Euzen Publisher: Editions TECHNIP ISBN: 9782710806462 Category : Science Languages : en Pages : 266
Book Description
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.
Author: Marko Zlokarnik Publisher: John Wiley & Sons ISBN: 3527607765 Category : Science Languages : en Pages : 296
Book Description
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.
Author: Attilio Bisio Publisher: Wiley-Interscience ISBN: Category : Science Languages : en Pages : 760
Book Description
The focus of this book is on the technical factors that are critical to th e design and startup of a commercial manufacturing facility.
Author: Mary T. am Ende Publisher: John Wiley & Sons ISBN: 111928550X Category : Technology & Engineering Languages : en Pages : 1435
Book Description
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.
Author: Ian Houson Publisher: John Wiley & Sons ISBN: 352763715X Category : Science Languages : en Pages : 346
Book Description
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: Joe M. Bonem Publisher: Elsevier ISBN: 0128137282 Category : Technology & Engineering Languages : en Pages : 232
Book Description
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
Author: Michael Levin Publisher: CRC Press ISBN: 9781616310011 Category : Medical Languages : en Pages : 0
Book Description
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.
Author: Gunter Jagschies Publisher: Elsevier ISBN: 0128125527 Category : Technology & Engineering Languages : en Pages : 1308
Book Description
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
Author: Jamal Chaouki
Author: Jamal Chaouki
Author: Jan Harmsen
Author: Jean-Paul Euzen
Author: Marko Zlokarnik
Author: Attilio Bisio
Author: Mary T. am Ende
Author: Ian Houson
Author: Joe M. Bonem
Author: Michael Levin
Author: Gunter Jagschies