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How To Design And Implement Powder To Tablet Continuous Manufacturing Systems

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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 Book
Author : Fernando Muzzio,Sarang Oka
Publisher : Academic Press
Release : 2019-02
ISBN : 9780128134795
Language : En, Es, Fr & De

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Book Description :

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

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing Book
Author : Zoltan K Nagy,Arwa El Hagrasy,Jim Litster
Publisher : Springer Nature
Release : 2020-06-10
ISBN : 3030415244
Language : En, Es, Fr & De

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Book Description :

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.

Combined Scheduling and Control

Combined Scheduling and Control Book
Author : John D. Hedengren,Logan Beal
Publisher : MDPI
Release : 2018-04-13
ISBN : 3038428051
Language : En, Es, Fr & De

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Book Description :

This book is a printed edition of the Special Issue "Combined Scheduling and Control" that was published in Processes

Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing Book
Author : Ravendra Singh,Zhihong Yuan
Publisher : Elsevier
Release : 2018-03-16
ISBN : 0444639667
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publisher : John Wiley & Sons
Release : 2017-07-14
ISBN : 1119001358
Language : En, Es, Fr & De

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Book Description :

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.

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

13th International Symposium on Process SystemsEngineering     PSE 2018  July 1 5 2018 Book
Author : Mario R. Eden,Gavin Towler,Maria Ierapetritou
Publisher : Elsevier
Release : 2018-07-19
ISBN : 0444642420
Language : En, Es, Fr & De

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Book Description :

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

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
Publisher : Academic Press
Release : 2016-11-08
ISBN : 0128026375
Language : En, Es, Fr & De

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Book Description :

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

Advanced Functional Materials

Advanced Functional Materials Book
Author : Nevin Tasaltin,Paul Sunday Nnamchi,Safaa Saud
Publisher : BoD – Books on Demand
Release : 2020-11-26
ISBN : 1839624795
Language : En, Es, Fr & De

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Book Description :

This book was written by authors in the field of preparation of advanced functional materials and their wide-ranging applications. The topics in the book include: preparation of several advanced functional materials, and their applications in sensors, health, concrete, textile, glasses, and pharmacy. In this book, the authors focused on recent studies, applications, and new technological developments in fundamental properties of advanced functional materials.

23rd European Symposium on Computer Aided Process Engineering

23rd European Symposium on Computer Aided Process Engineering Book
Author : Anonim
Publisher : Elsevier
Release : 2013-06-10
ISBN : 0444632417
Language : En, Es, Fr & De

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Book Description :

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

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry Book
Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Release : 2019-04-09
ISBN : 1119285496
Language : En, Es, Fr & De

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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.

21st European Symposium on Computer Aided Process Engineering

21st European Symposium on Computer Aided Process Engineering Book
Author : Anonim
Publisher : Elsevier
Release : 2011-06-10
ISBN : 0444538968
Language : En, Es, Fr & De

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Book Description :

The European Symposium on Computer Aided Process Engineering (ESCAPE) series presents the latest innovations and achievements of leading professionals from the industrial and academic communities. The ESCAPE series serves as a forum for engineers, scientists, researchers, managers and students to present and discuss progress being made in the area of computer aided process engineering (CAPE). European industries large and small are bringing innovations into our lives, whether in the form of new technologies to address environmental problems, new products to make our homes more comfortable and energy efficient or new therapies to improve the health and well being of European citizens. Moreover, the European Industry needs to undertake research and technological initiatives in response to humanity's "Grand Challenges," described in the declaration of Lund, namely, Global Warming, Tightening Supplies of Energy, Water and Food, Ageing Societies, Public Health, Pandemics and Security. Thus, the Technical Theme of ESCAPE 21 will be "Process Systems Approaches for Addressing Grand Challenges in Energy, Environment, Health, Bioprocessing & Nanotechnologies."

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology Book
Author : Dilip M. Parikh
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1616310030
Language : En, Es, Fr & De

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Book Description :

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

Control of Mechatronic Systems

Control of Mechatronic Systems Book
Author : Patrick O. J. Kaltjob
Publisher : John Wiley & Sons
Release : 2021-02-08
ISBN : 1119505801
Language : En, Es, Fr & De

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Book Description :

A practical methodology for designing integrated automation control for systems and processes Implementing digital control within mechanical-electronic (mechatronic) systems is essential to respond to the growing demand for high-efficiency machines and processes. In practice, the most efficient digital control often integrates time-driven and event-driven characteristics within a single control scheme. However, most of the current engineering literature on the design of digital control systems presents discrete-time systems and discrete-event systems separately. Control Of Mechatronic Systems: Model-Driven Design And Implementation Guidelines unites the two systems, revisiting the concept of automated control by presenting a unique practical methodology for whole-system integration. With its innovative hybrid approach to the modeling, analysis, and design of control systems, this text provides material for mechatronic engineering and process automation courses, as well as for self-study across engineering disciplines. Real-life design problems and automation case studies help readers transfer theory to practice, whether they are building single machines or large-scale industrial systems. Presents a novel approach to the integration of discrete-time and discrete-event systems within mechatronic systems and industrial processes Offers user-friendly self-study units, with worked examples and numerous real-world exercises in each chapter Covers a range of engineering disciplines and applies to small- and large-scale systems, for broad appeal in research and practice Provides a firm theoretical foundation allowing readers to comprehend the underlying technologies of mechatronic systems and processes Control Of Mechatronic Systems is an important text for advanced students and professionals of all levels engaged in a broad range of engineering disciplines.

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

Formulation and Validation of a Population Balance Model for Powder Mixing Process Book
Author : Joyce John
Publisher : Unknown
Release : 2013
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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].

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations Book
Author : Preetanshu Pandey,Rahul Bharadwaj
Publisher : Woodhead Publishing
Release : 2016-09-26
ISBN : 0081001800
Language : En, Es, Fr & De

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Book Description :

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

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology Book
Author : Dilip Parikh
Publisher : Academic Press
Release : 2017-04-04
ISBN : 0128047283
Language : En, Es, Fr & De

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Book Description :

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

23 European Symposium on Computer Aided Process Engineering

23 European Symposium on Computer Aided Process Engineering Book
Author : Ravendra Singh,Marianthi Ierapetritou,Rohit Ramachandran
Publisher : Elsevier Inc. Chapters
Release : 2013-06-10
ISBN : 0128086254
Language : En, Es, Fr & De

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Book Description :

The direct compaction continuous pharmaceutical tablet manufacturing process considered in this study is highly interactive and has time delays for several process variables due to sensor placements, that indicate that a simple feedback regulatory control system (e.g. PI(D)) by itself may not be sufficient to achieve the tight process control as imposed by regulatory authorities. This process comprises of coupled dynamics involving slow and fast responses indicating the requirement of a hybrid control scheme such as an advanced hybrid MPC-PID control scheme. In this article, an efficient plant-wide hybrid MPC-PID control strategy for an integrated continuous pharmaceutical tablet manufacturing process via direct compaction has been designed in silico. The designed hybrid control system has been implemented in a first principle model-based flowsheet that was simulated in gPROMS (PSE). Results demonstrated enhanced performance of critical quality attributes (CQAs) under the hybrid control scheme compared to only PID or MPC control schemes thus illustrating the potential of hybrid control scheme in improving pharmaceutical manufacturing operations. A systematic methodology for design and implementation of hybrid MPC-PID control system has been also developed that can be employed for other processes.

29th European Symposium on Computer Aided Chemical Engineering

29th European Symposium on Computer Aided Chemical Engineering Book
Author : Anton A. Kiss,Edwin Zondervan,Richard Lakerveld,Leyla Özkan
Publisher : Elsevier
Release : 2019-07-03
ISBN : 0128186356
Language : En, Es, Fr & De

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Book Description :

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

Remington

Remington Book
Author : Adeboye Adejare
Publisher : Academic Press
Release : 2020-11-03
ISBN : 0128223898
Language : En, Es, Fr & De

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Book Description :

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