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Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
  • Author : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
  • Publisher :Unknown
  • Release Date :2017-09-05
  • Total pages :620
  • ISBN : 9781119001324
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Summary : 10.7.3 State of Control

Combined Scheduling and Control

Combined Scheduling and Control
  • Author : John D. Hedengren,Logan Beal
  • Publisher :Unknown
  • Release Date :2018-04-13
  • Total pages :174
  • ISBN : 9783038428053
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Summary : This book is a printed edition of the Special Issue "Combined Scheduling and Control" that was published in Processes

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing
  • Author : Zoltan K Nagy,Arwa El Hagrasy,Jim Litster
  • Publisher :Unknown
  • Release Date :2020-06-10
  • Total pages :541
  • ISBN : 9783030415242
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Summary : Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing
  • Author : Ravendra Singh,Zhihong Yuan
  • Publisher :Unknown
  • Release Date :2018-03-16
  • Total pages :698
  • ISBN : 9780444639660
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Summary : 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

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
  • Author : Ajit S. Narang,Sherif I.F. Badawy
  • Publisher :Unknown
  • Release Date :2018-08-31
  • Total pages :890
  • ISBN : 9780323481038
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Summary : Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
  • Author : Preetanshu Pandey,Rahul Bharadwaj
  • Publisher :Unknown
  • Release Date :2016-09-26
  • Total pages :464
  • ISBN : 9780081001806
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Summary : The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Cost Control and Information Systems

Cost Control and Information Systems
  • Author : Pravin P. Shah
  • Publisher :Unknown
  • Release Date :1981
  • Total pages :575
  • ISBN : UOM:39076000595053
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Summary :

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
  • Author : Dilip M. Parikh
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :676
  • ISBN : 9781616310035
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Summary : The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

Thomas' Register of American Manufacturers

Thomas' Register of American Manufacturers
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2003
  • Total pages :229
  • ISBN : UIUC:30112060354948
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Summary :

Continuous Granulation with a Twin-Screw Extruder

Continuous Granulation with a Twin-Screw Extruder
  • Author : Dejan Djuric
  • Publisher :Unknown
  • Release Date :2008
  • Total pages :104
  • ISBN : 9783867276436
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Summary :

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher :Unknown
  • Release Date :2019-03-27
  • Total pages :448
  • ISBN : 9780128163726
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Summary : Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Advanced Manufacturing Systems, ICMSE 2011

Advanced Manufacturing Systems, ICMSE 2011
  • Author : Dao Guo Yang,Tian Long Gu,Huai Ying Zhou,Jian Min Zeng,Zheng Yi Jiang
  • Publisher :Unknown
  • Release Date :2011-02-21
  • Total pages :3094
  • ISBN : 9783038135821
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Summary : This work brings together the latest applications of, and advances in, CAD/CAM/CAE, energy storage and energy development, mining machinery manufacturing, new energy equipment and manufacturing, cloud manufacturing and extreme manufacturing, bio-manufacturing, enterprise informationization, integrated manufacturing systems, quality monitoring and control of manufacturing processes, measurement control technologies and intelligent systems, embedded systems, etc. This broad overview of the latest advances also provides a reference source for researchers in this field.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
  • Author : Shayne Cox Gad
  • Publisher :Unknown
  • Release Date :2008-03-21
  • Total pages :1384
  • ISBN : 9780470259801
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Summary : This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Formulation and Analytical Development for Low-Dose Oral Drug Products

Formulation and Analytical Development for Low-Dose Oral Drug Products
  • Author : Jack Zheng
  • Publisher :Unknown
  • Release Date :2009-02-09
  • Total pages :496
  • ISBN : 9780470056097
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Summary : There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Melt Extrusion

Melt Extrusion
  • Author : Michael A. Repka,Nigel Langley,James DiNunzio
  • Publisher :Unknown
  • Release Date :2013-10-11
  • Total pages :474
  • ISBN : 9781461484325
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Summary : This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

3D Printing of Pharmaceuticals

3D Printing of Pharmaceuticals
  • Author : Abdul W. Basit,Simon Gaisford
  • Publisher :Unknown
  • Release Date :2018-08-06
  • Total pages :240
  • ISBN : 9783319907550
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Summary : 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Advances in Sustainable and Competitive Manufacturing Systems

Advances in Sustainable and Competitive Manufacturing Systems
  • Author : Américo Azevedo
  • Publisher :Unknown
  • Release Date :2013-06-25
  • Total pages :1693
  • ISBN : 9783319005577
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Summary : The proceedings includes the set of revised papers from the 23rd International Conference on Flexible Automation and Intelligent Manufacturing (FAIM 2013). This conference aims to provide an international forum for the exchange of leading edge scientific knowledge and industrial experience regarding the development and integration of the various aspects of Flexible Automation and Intelligent Manufacturing Systems covering the complete life-cycle of a company’s Products and Processes. Contents will include topics such as: Product, Process and Factory Integrated Design, Manufacturing Technology and Intelligent Systems, Manufacturing Operations Management and Optimization and Manufacturing Networks and MicroFactories.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
  • Author : Larry L. Augsburger,Stephen W. Hoag
  • Publisher :Unknown
  • Release Date :2017-10-30
  • Total pages :421
  • ISBN : 9781841849775
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Summary : Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Product Design for Manufacture and Assembly, Second Edition, Revised and Expanded

Product Design for Manufacture and Assembly, Second Edition, Revised and Expanded
  • Author : Geoffrey Boothroyd,Peter Dewhurst,Winston Anthony Knight
  • Publisher :Unknown
  • Release Date :1994
  • Total pages :540
  • ISBN : 1230987654XX
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Summary : Presents a summary of the analytical tools used to evaluate the cost and difficulty of manufacturing and assembling proposed product designs, encouraging a continuous dialogue between designers and manufacturing engineers during the early stages of design.

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing
  • Author : Ganapathy Subramanian
  • Publisher :Unknown
  • Release Date :2015-02-09
  • Total pages :528
  • ISBN : 9783527335954
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Summary : With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Strategies for Formulations Development

Strategies for Formulations Development
  • Author : Ronald Snee,Roger Hoerl
  • Publisher :Unknown
  • Release Date :2016-09-27
  • Total pages :294
  • ISBN : 9781629605302
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Summary : Strategies for Formulations Development: A Step-by-Step Guide Using JMP is based on the authors' significant practical experience partnering with scientists to develop strategies to accelerate the formulation (mixtures) development process. The authors not only explain the most important methods used to design and analyze formulation experiments, but they also present overall strategies to enhance both the efficiency and effectiveness of the development process. With this book you will be able to: Approach the development process from a strategic viewpoint with the overall end result in mind. Design screening experiments to identify components that are most important to the performance of the formulation. Design optimization experiments to identify the maximum response in the design space. Analyze both screening and optimization experiments using graphical and numerical methods. Optimize multiple criteria, such as the quality, cost, and performance of product formulations. Design and analyze formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%. Linking dynamic graphics with powerful statistics, JMP helps construct a visually compelling narrative to interactively share findings that are coherent and actionable by colleagues and decision makers. Using this book, you can take advantage of computer generated experiment designs when classical designs do not suffice, given the physical and economic constraints of the experiential environment. Strategies for Formulations Development: A Step-by-Step Guide Using JMP(R) is unique because it provides formulation scientists with the essential information they need in order to successfully conduct formulation studies in the chemical, biotech, and pharmaceutical industries.