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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 : 2022-04-15
ISBN : 0128134801
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 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

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.

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

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].

Thomas Register

Thomas Register Book
Author : Anonim
Publisher : Unknown
Release : 2004
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Thomas Register book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

MRPII Integrating the Business

MRPII  Integrating the Business Book
Author : Martyn Luscombe
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download MRPII Integrating the Business book written by Martyn Luscombe, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Chemical Engineer

The Chemical Engineer Book
Author : Anonim
Publisher : Unknown
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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The Canadian Patent Office Record

The Canadian Patent Office Record Book
Author : Anonim
Publisher : Unknown
Release : 1964
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Canadian Patent Office Record book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Conference Papers Index

Conference Papers Index Book
Author : Anonim
Publisher : Unknown
Release : 1982
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Monthly. Papers presented at recent meeting held all over the world by scientific, technical, engineering and medical groups. Sources are meeting programs and abstract publications, as well as questionnaires. Arranged under 17 subject sections, 7 of direct interest to the life scientist. Full programs of meetings listed under sections. Entry gives citation number, paper title, name, mailing address, and any ordering number assigned. Quarterly and annual indexes to subjects, authors, and programs (not available in monthly issues).

Canadian Patent Office Record

Canadian Patent Office Record Book
Author : Canada. Patent Office
Publisher : Unknown
Release : 1956-11
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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The Canadian Patent Office Record and Register of Copyrights

The Canadian Patent Office Record and Register of Copyrights Book
Author : Anonim
Publisher : Unknown
Release : 1956
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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Scientific American

Scientific American Book
Author : Anonim
Publisher : Unknown
Release : 1893
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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Technical Digest

Technical Digest Book
Author : Anonim
Publisher : Unknown
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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Gazette Du Bureau Des Brevets

Gazette Du Bureau Des Brevets Book
Author : Canada. Patent Office
Publisher : Unknown
Release : 1971
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Includes annual cumulative index of inventors and patentees.

Current Awareness in Particle Technology

Current Awareness in Particle Technology Book
Author : Anonim
Publisher : Unknown
Release : 1992
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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