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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
Author: Fernando Muzzio
Publisher: Elsevier
Total Pages: 442
Release: 2022-04
Genre: Medical
ISBN: 0128134798

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How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it 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 in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the 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


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

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems
Author: Fernando Muzzio
Publisher: Academic Press
Total Pages: 444
Release: 2022-03-29
Genre: Medical
ISBN: 0128134801

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How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it 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 in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the 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 Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
Author: Peter Kleinebudde
Publisher: John Wiley & Sons
Total Pages: 645
Release: 2017-09-05
Genre: Science
ISBN: 1119001323

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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
Author: Ravendra Singh
Publisher: Elsevier
Total Pages: 700
Release: 2018-03-16
Genre: Technology & Engineering
ISBN: 0444639667

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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


Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
Author: Preetanshu Pandey
Publisher: Woodhead Publishing
Total Pages: 465
Release: 2016-09-26
Genre: Medical
ISBN: 0081001800

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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


23 European Symposium on Computer Aided Process Engineering

23 European Symposium on Computer Aided Process Engineering
Author: Ravendra Singh
Publisher: Elsevier Inc. Chapters
Total Pages: 16
Release: 2013-06-10
Genre: Science
ISBN: 0128086254

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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.


Design, Modeling and Real-time Monitoring of Continuous Powder Mixing Processes

Design, Modeling and Real-time Monitoring of Continuous Powder Mixing Processes
Author: Aditya U. Vanarase
Publisher:
Total Pages: 159
Release: 2011
Genre: Manufacturing processes
ISBN:

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Continuous processing is an advantageous alternative for the current methods used in the pharmaceutical manufacturing. Important advantages that it offers include smaller equipment footprint, reduced efforts in the scale-up work, and the potential to utilize already continuous processes to make the entire manufacturing more efficient. In the current pharmaceutical manufacturing environment, powder mixing process is carried out in the batch mode. The necessary methods and guidelines to design an equivalent continuous process are not well established. The work presented in this dissertation focuses on the characterization, design and optimization of a continuous powder mixing process for pharmaceutical powders. A systematic study was performed of the effects of process and design variables, and material properties involved in the continuous powder mixing process. The bulk powder flow behavior was characterized using the residence time distribution (RTD) measurement approach. Impeller speed, material bulk density and impeller design greatly influenced the mean residence time. With increasing impeller speed, mechanical fluidization was observed, which significantly affected axial dispersion coefficients. Intermediate rotation rates exerted maximum strain on the material, which leads to maximum homogenization. The strain measurements correlated well with the properties of tablets including content uniformity and tablet hardness. Mixing performance was largely dominated by the material properties of the mixture, and the blend uniformity measurement was affected by the sample size analyzed. An experimental protocol was developed to measure the blend uniformity in the in-line mode, and a methodology was further built to quantitatively relate the in-line NIR measurements with the off-line wet chemistry measurements. Considering the shear limitations of the continuous bladed mixer, alternative blending strategies, suitable for blending of cohesive materials were also demonstrated. A combination of a high-shear mixing followed by a low-shear mixing process provided the optimal mixing performance. The predictive understanding of the continuous powder mixing process developed in this dissertation can assist towards the design and development of a fully controlled continuous manufacturing process.


Modeling and Analysis of Continuous Powder Blending

Modeling and Analysis of Continuous Powder Blending
Author: Yijie Gao
Publisher:
Total Pages: 164
Release: 2012
Genre: Manufacturing processes
ISBN:

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The main focus of our research is to investigate continuous powder blending. The unit operation of powder blending is widely used to reduce the heterogeneity degree of product mixture in the manufacture of catalysts, cement, food, metal parts, and many other industrial products. Currently in pharmaceutical industry, continuous powder blending has received more attention as an efficient alternative to the traditional batch blending of powders due to its ability in handling high-flux continuous tablet manufacturing. Numerous previous approaches have been performed focusing on investigating the applicability of continuous manufacturing system. However, the development of reliable industrial system is limited by the inaccuracy of mixing index, the complicated effects of operating conditions and the black-box characterization method, all of which result from the lack of a theoretical model that can quantitatively characterize the whole continuous powder mixing process. Therefore, the overall research objective of this work is to develop a general standard method for quantitative process design and control. In this context, three different specific aims are accomplished. We analyze and distinguish different heterogeneity sources in the continuous blending process and develop a general model of continuous blending. Fourier series is applied to characterize the axial blending component, and a periodic section model is developed to capture the cross-sectional blending component. Based on the modeling work, efficient design, control, and scale-up strategies applicable for practical blending of pharmaceutical powders are determined. The effectiveness of the methodology is demonstrated in particle blending simulations and experiments using industrial mixing apparatuses to check its applicability and robustness in pharmaceutical industrial use.


Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
Genre: Science
ISBN: 0470259809

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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.