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Predictive Modeling Of Pharmaceutical Unit Operations

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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

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 : 2019-04-01
ISBN : 1119285518
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.

Global Supply Chains in the Pharmaceutical Industry

Global Supply Chains in the Pharmaceutical Industry Book
Author : Nozari, Hamed,Szmelter, Agnieszka
Publisher : IGI Global
Release : 2018-11-09
ISBN : 1522559221
Language : En, Es, Fr & De

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Book Description :

In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.

Process Modelling and Simulation

Process Modelling and Simulation Book
Author : César de Prada,Constantinos Pantelides,José Luis Pitarch
Publisher : MDPI
Release : 2019-09-23
ISBN : 3039214551
Language : En, Es, Fr & De

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Book Description :

Since process models are nowadays ubiquitous in many applications, the challenges and alternatives related to their development, validation, and efficient use have become more apparent. In addition, the massive amounts of both offline and online data available today open the door for new applications and solutions. However, transforming data into useful models and information in the context of the process industry or of bio-systems requires specific approaches and considerations such as new modelling methodologies incorporating the complex, stochastic, hybrid and distributed nature of many processes in particular. The same can be said about the tools and software environments used to describe, code, and solve such models for their further exploitation. Going well beyond mere simulation tools, these advanced tools offer a software suite built around the models, facilitating tasks such as experiment design, parameter estimation, model initialization, validation, analysis, size reduction, discretization, optimization, distributed computation, co-simulation, etc. This Special Issue collects novel developments in these topics in order to address the challenges brought by the use of models in their different facets, and to reflect state of the art developments in methods, tools and industrial applications.

Advances in Industrial Machines and Mechanisms

Advances in Industrial Machines and Mechanisms Book
Author : Anonim
Publisher : Springer Nature
Release : 2021
ISBN : 9811617694
Language : En, Es, Fr & De

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Book Description :

This book presents the select proceedings of the 1st International 13th National Conference on Industrial Problems on Machines and Mechanism (IPRoMM 2020) and examines issues in the design, manufacture, and performance of mechanical and mechatronic elements and systems that are employed in modern machines and devices. The topics covered include robotics, industrial CAD/CAM systems, mechatronics, machinery associated with conventional and unconventional manufacturing systems, material handling and automated assembly, mechanical and electro-mechanical systems of modern machinery and equipment, micro-devices, compliant mechanisms, hybrid electric vehicle and electric vehicle mechanisms, acoustic and noise control. This book also discusses the recent advances in the integration of IoT and Industry 4.0 in mechanism and machines. The book will be a valuable reference for academicians, researchers, and professionals interested in the design and development of industrial machines.

Preparing for FDA Pre Approval Inspections

Preparing for FDA Pre Approval Inspections Book
Author : Martin D. Hynes
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1000654370
Language : En, Es, Fr & De

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Book Description :

This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th

Proceedings of the 8th International Conference on Foundations of Computer Aided Process Design

Proceedings of the 8th International Conference on Foundations of Computer Aided Process Design Book
Author : Anonim
Publisher : Elsevier
Release : 2014-07-14
ISBN : 0444634428
Language : En, Es, Fr & De

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Book Description :

This volume collects together the presentations at the Eighth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2014, an event that brings together researchers, educators, and practitioners to identify new challenges and opportunities for process and product design. The chemical industry is currently entering a new phase of rapid evolution. The availability of low-cost feedstocks from natural gas is causing renewed investment in basic chemicals in the OECD, while societal pressures for sustainability and energy security continue to be key drivers in technology development and product selection. This dynamic environment creates opportunities to launch new products and processes and to demonstrate new methodologies for innovation, synthesis and design. FOCAPD-2014 fosters constructive interaction among thought leaders from academia, industry, and government and provides a showcase for the latest research in product and process design. Focuses exclusively on the fundamentals and applications of computer-aided design for the process industries. Provides a fully archival and indexed record of the FOCAPD14 conference Aligns the FOCAPD series with the ESCAPE and PSE series

17th European Symposium on Computed Aided Process Engineering

17th European Symposium on Computed Aided Process Engineering Book
Author : Valentin Plesu,Paul Serban Agachi
Publisher : Elsevier
Release : 2007-05-24
ISBN : 9780080546315
Language : En, Es, Fr & De

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Book Description :

The 17th European Symposium on Computed Aided Process Engineering contains papers presented at the 17th European Symposium of Computer Aided Process Engineering (ESCAPE 17) held in Bucharest, Romania, from 27-30 May 2007. The ESCAPE series serves as a forum for scientists and engineers from academia and industry to discuss progress achieved in the area of Computer Aided Process Engineering (CAPE). The main goal was to emphasize the continuity in research of innovative concepts and systematic design methods as well the diversity of applications emerged from the demands of sustainable development. ESCAPE 17 highlights the progresss software technology needed for implementing simulation based tools. The symposium is based on 5 themes and 27 topics, following the main trends in CAPE area: Modelling, Process and Products Design, Optimisation and Optimal Control and Operation, System Biology and Biological Processes, Process Integration and Sustainable Development. Participants from 50 countries attended and invited speakers presented 5 plenary lectures tackling broad subjects and 10 keynote lectures. Satellite events added a plus to the scientific dimension to this symposium. * All contributions are included on the CD-ROM attached to the book * Attendance from 50 countries with invited speakers presenting 5 plenary lectures tackling broad subjects and 10 keynote lectures

26th European Symposium on Computer Aided Process Engineering

26th European Symposium on Computer Aided Process Engineering Book
Author : Anonim
Publisher : Elsevier
Release : 2016-06-17
ISBN : 0444634444
Language : En, Es, Fr & De

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Book Description :

26th European Symposium on Computer Aided Process Engineering contains the papers presented at the 26th European Society of Computer-Aided Process Engineering (ESCAPE) Event held at Portorož Slovenia, from June 12th to June 15th, 2016. Themes discussed at the conference include Process-product Synthesis, Design and Integration, Modelling, Numerical analysis, Simulation and Optimization, Process Operations and Control and Education in CAPE/PSE. Presents findings and discussions from the 26th European Society of Computer-Aided Process Engineering (ESCAPE) Event

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book
Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Release : 2017-08-30
ISBN : 1119356164
Language : En, Es, Fr & De

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Book Description :

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Chemical Product Design Towards a Perspective through Case Studies

Chemical Product Design  Towards a Perspective through Case Studies Book
Author : Ka M. Ng,Rafiqul Gani,Kim Dam-Johansen
Publisher : Elsevier
Release : 2006-10-24
ISBN : 9780080466743
Language : En, Es, Fr & De

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Book Description :

Chemical Product Design: Towards a Perspective through Case Studies provides a framework for chemical product design problems which are clearly defined together with different solution approaches. This book covers the latest methods and tools currently available in the field and discusses future challenges that the chemical industry is faced with. It focuses on important issues of chemical product design and provides a good overview on industrial chemical product design problems through case studies supplied by leading experts. The editors of Chemical Product Design teach chemical product design at graduate level courses and also serve as consultants for various chemical companies. They have also developed experimental techniques for chemical product design as well as computer-aided design methods and tools. Highlights important issues of chemical product design through case studies Case studies supplied by leading experts in chemical product design Provides a complete framework for chemical product design

Pharmaceutical Inhalation Aerosol Technology Third Edition

Pharmaceutical Inhalation Aerosol Technology  Third Edition Book
Author : Anthony J. Hickey,Sandro R. da Rocha
Publisher : CRC Press
Release : 2019-03-26
ISBN : 042962171X
Language : En, Es, Fr & De

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Book Description :

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

Mesoscale Modeling in Chemical Engineering

Mesoscale Modeling in Chemical Engineering Book
Author : Anonim
Publisher : Academic Press
Release : 2015-11-26
ISBN : 0128013540
Language : En, Es, Fr & De

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Book Description :

Focusing Mesoscales of Multiscale Problems in Chemical Engineering, a volume in the Advances in Chemical Engineering series provides readers with the personal views of recognized authorities who present assessments of the state-of-the-art in the field and help readers develop an understanding of its further evolution. Subjects covered in the book are not limited to the classical chemical engineering disciplines. Contributions connecting chemical engineering to related scientific fields, either providing a fundamental basis or introducing new concepts and tools, are encouraged. This volume aims to create a balance between well developed areas such as process industry, transformation of materials, energy, and environmental issues, and areas where applications of chemical engineering are more recent or emerging. Contains reviews by leading authorities in their respective areas Provides up-to-date reviews of the latest techniques in the modeling of catalytic processes Includes a broad mix of US and European authors, as well as academic/industrial/research institute perspectives Provides discussions on the connections between computation and experimental methods

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].

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

Biopharmaceutical Production Technology 2 Volume Set

Biopharmaceutical Production Technology  2 Volume Set Book
Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
Release : 2012-08-20
ISBN : 3527330291
Language : En, Es, Fr & De

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Book Description :

Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

28TH EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING

28TH EUROPEAN SYMPOSIUM ON COMPUTER AIDED PROCESS ENGINEERING Book
Author : Stefan Radl,Jiri J Klemes,Petar Sabev Varbanov,Thomas Wallek
Publisher : Elsevier
Release : 2018-06-26
ISBN : 0444642366
Language : En, Es, Fr & De

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Book Description :

28th European Symposium on Computer Aided Process Engineering, Volume 43 contains the papers presented at the 28th European Society of Computer-Aided Process Engineering (ESCAPE) event held in Graz, Austria June 10-13 , 2018. 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 28th European Society of Computer-Aided Process Engineering (ESCAPE) event

Chemical Engineering in the Pharmaceutical Industry Active Pharmaceutical Ingredients

Chemical Engineering in the Pharmaceutical Industry  Active Pharmaceutical Ingredients Book
Author : David J. am Ende,Mary T. am Ende
Publisher : John Wiley & Sons
Release : 2019-03-28
ISBN : 1119285887
Language : En, Es, Fr & De

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Book Description :

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

18th European Symposium on Computer Aided Process Engineering

18th European Symposium on Computer Aided Process Engineering Book
Author : Bertrand Braunschweig,Xavier Joulia
Publisher : Elsevier
Release : 2008
ISBN : 0444532277
Language : En, Es, Fr & De

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Book Description :

The 18th European Symposium on Computer Aided Process Engineering contains papers presented at the 18th European Symposium of Computer Aided Process Engineering (ESCAPE 18) held in Lyon, France, from 1-4 June 2008. The ESCAPE series brings the latest innovations and achievements by leading professionals from the industrial and academic communities. The series serves as a forum for engineers, scientists, researchers, managers and students from academia and industry to: - present new computer aided methods, algorithms, techniques related to process and product engineering, - discuss innovative concepts, new challenges, needs and trends in the area of CAPE. This research area bridges fundamental sciences (physics, chemistry, thermodynamics, applied mathematics and computer sciences) with the various aspects of process and product engineering. The special theme for ESCAPE-18 is CAPE for the Users! CAPE systems are to be put in the hands of end users who need functionality and assistance beyond the scientific and technological capacities which are at the core of the systems. The four main topics are: - off-line systems for synthesis and design, - on-line systems for control and operation, - computational and numerical solutions strategies, - integrated and multi-scale modelling and simulation, Two general topics address the impact of CAPE tools and methods on Society and Education. * CD-ROM that accompanies the book contains all research papers and contributions * International in scope with guest speeches and keynote talks from leaders in science and industry * Presents papers covering the latest research, key top areas and developments in Computer Aided Process Engineering