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How to Design and Implement Powder-To-Tablet Continuous Manufacturing Systems

How to Design and Implement Powder-To-Tablet Continuous Manufacturing Systems
A Book

by Fernando Muzzio,Sarang Oka

  • Publisher : Academic Press
  • Release : 2019-02
  • Pages : 304
  • ISBN : 9780128134795
  • Language : En, Es, Fr & De
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How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview of the considerations necessary in the design of continuous pharmaceutical manufacturing processes. This book covers both the theory and design of continuous processing of the associated unit operations, along with their characterization and control. It also discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. Discusses the development of strategy blueprints for design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, use of statistical methods to analyze material property data, and the use of material databases Covers the evolving regulatory expectations for continuous manufacturing Provides readers with ways to more effectively navigate these expectations

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
A Book

by Preetanshu Pandey,Rahul Bharadwaj

  • Publisher : Woodhead Publishing
  • Release : 2016-09-26
  • Pages : 464
  • ISBN : 0081001800
  • Language : En, Es, Fr & De
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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

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing
A Book

by Zoltan K Nagy,Arwa El Hagrasy,Jim Litster

  • Publisher : Springer Nature
  • Release : 2020-06-10
  • Pages : 541
  • ISBN : 3030415244
  • Language : En, Es, Fr & De
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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.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice

by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri

  • Publisher : Academic Press
  • Release : 2016-11-08
  • Pages : 1176
  • ISBN : 0128026375
  • Language : En, Es, Fr & De
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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
A Book

by Peter Kleinebudde,Johannes Khinast,Jukka Rantanen

  • Publisher : John Wiley & Sons
  • Release : 2017-07-14
  • Pages : 632
  • ISBN : 1119001358
  • Language : En, Es, Fr & De
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A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing
A Book

by Ravendra Singh,Zhihong Yuan

  • Publisher : Elsevier
  • Release : 2018-03-16
  • Pages : 698
  • ISBN : 0444639667
  • Language : En, Es, Fr & De
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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

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
A Book

by Peter Kleinebudde,Johannes Khinast,Jukka Rantanen

  • Publisher : John Wiley & Sons
  • Release : 2017-09-05
  • Pages : 620
  • ISBN : 1119001323
  • Language : En, Es, Fr & De
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10.7.3 State of Control

Combined Scheduling and Control

Combined Scheduling and Control
A Book

by John D. Hedengren,Logan Beal

  • Publisher : MDPI
  • Release : 2018-04-13
  • Pages : 174
  • ISBN : 3038428051
  • Language : En, Es, Fr & De
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This book is a printed edition of the Special Issue "Combined Scheduling and Control" that was published in Processes

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
A Book

by Dilip M. Parikh

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 676
  • ISBN : 1616310030
  • Language : En, Es, Fr & De
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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

13th International Symposium on Process SystemsEngineering – PSE 2018, July 1-5 2018

13th International Symposium on Process SystemsEngineering – PSE 2018, July 1-5 2018
A Book

by Mario R. Eden,Gavin Towler,Maria Ierapetritou

  • Publisher : Elsevier
  • Release : 2018-07-19
  • Pages : 2602
  • ISBN : 0444642420
  • Language : En, Es, Fr & De
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Process Systems Engineering brings together the international community of researchers and engineers interested in computing-based methods in process engineering. This conference highlights the contributions of the PSE community towards the sustainability of modern society and is based on the 13th International Symposium on Process Systems Engineering PSE 2018 event held San Diego, CA, July 1-5 2018. The book contains contributions from academia and industry, establishing the core products of PSE, defining the new and changing scope of our results, and future challenges. Plenary and keynote lectures discuss real-world challenges (globalization, energy, environment and health) and contribute to discussions on the widening scope of PSE versus the consolidation of the core topics of PSE. Highlights how the Process Systems Engineering community contributes to the sustainability of modern society Establishes the core products of Process Systems Engineering Defines the future challenges of Process Systems Engineering

Remington

Remington
The Science and Practice of Pharmacy

by Adeboye Adejare

  • Publisher : Academic Press
  • Release : 2020-11-03
  • Pages : 1030
  • ISBN : 0128223898
  • Language : En, Es, Fr & De
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Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology
Part of the Expertise in Pharmaceutical Process Technology Series

by Dilip Parikh

  • Publisher : Academic Press
  • Release : 2017-04-04
  • Pages : 210
  • ISBN : 0128047283
  • Language : En, Es, Fr & De
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How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation. Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques Offers troubleshooting tips and practical advice for scientists working with this technique

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing
A Book

by P. J. Cullen,Rodolfo J. Romañach,Nicolas Abatzoglou,Chris D. Rielly

  • Publisher : John Wiley & Sons
  • Release : 2015-05-11
  • Pages : 512
  • ISBN : 1118683455
  • Language : En, Es, Fr & De
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Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

23rd European Symposium on Computer Aided Process Engineering

23rd European Symposium on Computer Aided Process Engineering
A Book

by Anonim

  • Publisher : Elsevier
  • Release : 2013-06-10
  • Pages : 1088
  • ISBN : 0444632417
  • Language : En, Es, Fr & De
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Computer-aided process engineering (CAPE) plays a key design and operations role in the process industries, from the molecular scale through managing complex manufacturing sites. The research interests cover a wide range of interdisciplinary problems related to the current needs of society and industry. ESCAPE 23 brings together researchers and practitioners of computer-aided process engineering interested in modeling, simulation and optimization, synthesis and design, automation and control, and education. The proceedings present and evaluate emerging as well as established research methods and concepts, as well as industrial case studies. Contributions from the international community using computer-based methods in process engineering Reviews the latest developments in process systems engineering Emphasis on industrial and societal challenges

Green Chemical Engineering

Green Chemical Engineering
A Book

by Anonim

  • Publisher : John Wiley & Sons
  • Release : 2018-07-19
  • Pages : 400
  • ISBN : 3527688404
  • Language : En, Es, Fr & De
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Green chemistry and chemical engineering belong together and this twelth volume in the successful Handbook of Green Chemistry series represents the perfect one-stop reference on the topic. Written by an international team of specialists with each section edited by international leading experts, this book provides first-hand insights into the field, covering chemical engineering process design, innovations in unit operations and manufacturing, biorefining and much more besides. An indispensable source for every chemical engineer in industry and academia.

Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering
A Book

by Gary Prager

  • Publisher : John Wiley & Sons
  • Release : 2018-11-28
  • Pages : 576
  • ISBN : 1119418844
  • Language : En, Es, Fr & De
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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.

29th European Symposium on Computer Aided Chemical Engineering

29th European Symposium on Computer Aided Chemical Engineering
A Book

by Anton A. Kiss,Edwin Zondervan,Richard Lakerveld,Leyla Özkan

  • Publisher : Elsevier
  • Release : 2019-07-03
  • Pages : 1892
  • ISBN : 0128186356
  • Language : En, Es, Fr & De
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The 29th European Symposium on Computer Aided Process Engineering, contains the papers presented at the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event held in Eindhoven, The Netherlands, from June 16-19, 2019. It is a valuable resource for chemical engineers, chemical process engineers, researchers in industry and academia, students, and consultants for chemical industries. Presents findings and discussions from the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event

The Prospect of Industry 5.0 in Biomanufacturing

The Prospect of Industry 5.0 in Biomanufacturing
A Book

by Pau Loke Show,Kit Wayne Chew,Tau Chuan Ling

  • Publisher : CRC Press
  • Release : 2021-07-02
  • Pages : 326
  • ISBN : 1000407438
  • Language : En, Es, Fr & De
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This is the first book to present the idea of Industry 5.0 in biomanufacturing and bioprocess engineering, both upstream and downstream. The Prospect of Industry 5.0 in Biomanufacturing details the latest technologies and how they can be used efficiently and explains process analysis from an engineering point of view. In addition, it covers applications and challenges. FEATURES Describes the previous Industrial Revolution, current Industry 4.0, and how new technologies will transition toward Industry 5.0 Explains how Industry 5.0 can be applied in biomanufacturing Demonstrates new technologies catered to Industry 5.0 Uses worked examples related to biological systems This book enables readers in industry and academia working in the biomanufacturing engineering sector to understand current trends and future directions in this field.

Formulation and Validation of a Population Balance Model for Powder Mixing Process

Formulation and Validation of a Population Balance Model for Powder Mixing Process
A Book

by Joyce John

  • Publisher : Unknown Publisher
  • Release : 2013
  • Pages : 62
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pharmaceutical processing is much more stringent with regulatory requirements for the processing and handling stages and the product quality specifications must be met at every step during the manufacturing operation. In the pharmaceutical manufacturing, the unit operation that is one among the most widely used, is the powder blending operation. The scope of this work is to characterize and document the complex powder blending process by means of a robust predictive model and use it to enhance operational efficiency and improve on the established monitoring and control strategies. The implementation of QbD (Quality by Design) strategies [1] to continuous processing stages allows for improved process control, higher cost-efficiency without compromising on the quality or efficacy of the final product. It also would alleviate the need for further scale up studies. In this work, a population balance model (PBM) has been formulated and validated to model the complex dynamics within a continuous powder mixing process, with the focus on the blending operation taking place within pharmaceutical tablet manufacturing. PBM modeling was selected to model the blending unit operation as it not only serves as a dynamic and highly effective tool, but also due to its relative computational simplicity. The model was designed to determine the critical quality attributes (such as RTD (residence time distribution), API composition and RSD (relative standard deviation) of the product by incorporating the key process parameters such as the impeller RPM, dimensions of the blender and design parameters such as the number of compartments (both axial and radial), etc. The model obtained has been subsequently validated to check the fit between the predicted values of these CQAs (Critical Quality Attributes) against experimentally obtained data during the same time intervals. The model has the potential use for process improvement by implementation in a PAT (Process Analytical Technique) system for designing improved monitoring, control and optimization techniques. [2].

Dosage Form Design Parameters

Dosage Form Design Parameters
A Book

by Anonim

  • Publisher : Academic Press
  • Release : 2018-07-25
  • Pages : 810
  • ISBN : 012814422X
  • Language : En, Es, Fr & De
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Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design