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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 : 2019-04-09
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.

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 : Y. V. D. Rao,C. Amarnath,Srinivasa Prakash Regalla,Arshad Javed,Kundan Kumar Singh
Publisher : Springer Nature
Release : 2021-07-20
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.

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.

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.

Feature Papers

Feature Papers Book
Author : Michael Henson
Publisher : MDPI
Release : 2018-10-04
ISBN : 3038420700
Language : En, Es, Fr & De

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Book Description :

This book is a printed edition of the Special Issue "Feature Papers" that was published in Processes

Model Based Tools for Pharmaceutical Manufacturing Processes

Model Based Tools for Pharmaceutical Manufacturing Processes Book
Author : Krist V. Gernaey,René Schenkendorf,Dimitrios I. Gerogiorgis,Seyed Soheil Mansouri
Publisher : MDPI
Release : 2020-03-13
ISBN : 303928424X
Language : En, Es, Fr & De

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Book Description :

The Special Issue on “Model-Based Tools for Pharmaceutical Manufacturing Processes” will curate novel advances in the development and application of model-based tools to address ever-present challenges of the traditional pharmaceutical manufacturing practice as well as new trends. This book provides a collection of nine papers on original advances in the model-based process unit, system-level, quality-by-design under uncertainty, and decision-making applications of pharmaceutical manufacturing processes.

Hybrid Modelling and Multi Parametric Control of Bioprocesses

Hybrid Modelling and Multi Parametric Control of Bioprocesses Book
Author : Christoph Herwig
Publisher : MDPI
Release : 2018-03-23
ISBN : 3038427454
Language : En, Es, Fr & De

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Book Description :

This book is a printed edition of the Special Issue "Hybrid Modelling and Multi-Parametric Control of Bioprocesses" that was published in Bioengineering

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].

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

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-04-04
ISBN : 9780470259825
Language : En, Es, Fr & De

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Book Description :

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

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

Pharmaceutical Extrusion Technology

Pharmaceutical Extrusion Technology Book
Author : Isaac Ghebre-Selassie,Charles Martin
Publisher : CRC Press
Release : 2003-05-14
ISBN : 0824755200
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Extrusion Technology is the only resource to provide in-depth descriptions and analyses of the key parameters of extruders and extrusion processes. The book highlights the applicability of melt extrusion in pharmaceutical drug development and product manufacturing, including controlled release, dissolution rate and bioavailability enhancement, and granulation technology. It brings together the technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements and details extruder hardware and controls, process definition and troubleshooting of single and twin screw extrusion processes, and more.

Integration and Optimization of Unit Operations

Integration and Optimization of Unit Operations Book
Author : Barry A. Perlmutter
Publisher : Elsevier
Release : 2022-06-24
ISBN : 0128236183
Language : En, Es, Fr & De

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Book Description :

The chemical industry changes and becomes more and more integrated worldwide. This creates a need for information exchange that includes not only the principles of operation but also the transfer of practical knowledge. Integration and Optimization of Unit Operations provides up-to-date and practical information on chemical unit operations from the R&D stage to scale-up and demonstration to commercialization and optimization. A global collection of industry experts systematically discuss all innovation stages, complex processes with different unit operations, including solids processing and recycle flows, and the importance of integrated process validation. The book addresses the needs of engineers who want to increase their skill levels in various disciplines so that they are able to develop, commercialize and optimize processes. After reading this book, you will be able to acquire new skills and knowledge to collaborate across disciplines and develop creative solutions. Shows the impacts of upstream process decisions on downstream operations Provides troubleshooting strategies at each process stage Asks challenging questions to develop creative solutions to process problems

Pharmaceutical and Medical Device Validation by Experimental Design

Pharmaceutical and Medical Device Validation by Experimental Design Book
Author : Lynn D Torbeck
Publisher : CRC Press
Release : 2007-06-26
ISBN : 1420055704
Language : En, Es, Fr & De

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Book Description :

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap

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

Computer aided applications in pharmaceutical technology

Computer aided applications in pharmaceutical technology Book
Author : Jelena Djuris,Svetlana Ibric,Zorica Djuric
Publisher : Elsevier Inc. Chapters
Release : 2013-04-10
ISBN : 0128091878
Language : En, Es, Fr & De

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Book Description :

This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product lifecycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from both regulatory and manufacturers’ points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and ease of its application.