Optimization Modeling and Variation Reduction in a Pharmaceutical Production Process by Quality Engineering and Robust Design - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Optimization Modeling and Variation Reduction in a Pharmaceutical Production Process by Quality Engineering and Robust Design write by Andrew Dada Ezekiel. This book was released on 2006. Optimization Modeling and Variation Reduction in a Pharmaceutical Production Process by Quality Engineering and Robust Design available in PDF, EPUB and Kindle. A key to be competitive in today's economy is to produce high-quality products at low production cost, to meet or exceed customer's requirements. Product and process variations cost manufacturing industry significant money in terms of high rework cost, scrap, and costly inspections. Reducing product and process variation in a production process is a vital issue in quality improvement programs, because variation grows into hundreds-of-thousands of dollars in added product cost per year. The objectives of this research are (1) to study the variability of a generic pharmaceutical filling process; (2) to generate the process capability and conduct process validation based on statistical process control (SPC); (3) to develop economic optimization models for the filling process; and then (4) to optimize the process mean (e.g., reduce the deviation of the average fill from the target value), as well as minimize the variability around the process mean in a generic liquid pharmaceutical filling operation. This research, motivated by the fact that many production processes are being run at sub-optimal settings, utilizes the combination of control charts and SPC to study the current variability, capability, and validation of our filling process. Then, we developed a model that accounts for both the controllable and uncontrollable factors, and the response variable. Based on the model, we used mixed-level factorial design and robust design methods to effectively determine the optimal level settings of controllable factors that minimize the variability in the fill weights, while keeping the mean fill weight on target. As a result, the response variable (the fill weight) was insensitive or robust to the variations in uncontrollable noise factors. We derived optimum specification limits for the filling process. This research provides consistent methods for process optimization and variation reduction that has been implemented to improve the performance of our filling operations. Consequently, we have decreased the amount of scrap, rework and the cost incurred by the firm. The approach and the models, based on Taguchi's robust design, can be applied to other similar production processes. -- Abstract.
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture write by Gintaras V. Reklaitis. This book was released on 2017-08-30. Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture available in PDF, EPUB and Kindle. 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.
Optimization of Pharmaceutical Processes
Optimization of Pharmaceutical Processes - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Optimization of Pharmaceutical Processes write by Antonios Fytopoulos. This book was released on 2022-04-06. Optimization of Pharmaceutical Processes available in PDF, EPUB and Kindle. Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.
Dissertation Abstracts International
Dissertation Abstracts International - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Dissertation Abstracts International write by . This book was released on 2006. Dissertation Abstracts International available in PDF, EPUB and Kindle.
Model-Based Tools for Pharmaceutical Manufacturing Processes
Model-Based Tools for Pharmaceutical Manufacturing Processes - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Model-Based Tools for Pharmaceutical Manufacturing Processes write by Krist V. Gernaey. This book was released on 2020-03-13. Model-Based Tools for Pharmaceutical Manufacturing Processes available in PDF, EPUB and Kindle. 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.
