Pharmaceutical Process Modeling, Optimization, and Control - 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 Pharmaceutical Process Modeling, Optimization, and Control write by Ehsan Sheikholeslamzadeh. This book was released on 2013. Pharmaceutical Process Modeling, Optimization, and Control available in PDF, EPUB and Kindle. In this project, the aim was to achieve two important objectives and solve some challenges that the pharmaceutical industry is facing. It will be shown that the NRTL-SAC (Non-random Two Liquid Segment Activity Coefficient) model can best predict the solubility of different pharmaceutical and chemical components in pure and mixed solvents by comparing the results with the well-known model of the UNIFAC. The four parameters that are used in the NRTL-SAC model will be found through nonlinear parameter estimation technique. This project also covers the VLE, LLE, and VLLE phase behaviour calculations using the mentioned models to verify their applicability in industries that use solvents as their main process materials (such as pharmaceutical processes). It will be explained that the NRTL-SAC model is efficient and less complex than the UNIFAC model when dealing with multi-component systems of solvents. The solvent screening process is then modeled using a novel method of modeling and optimization which resulted in a significant change in the objective functions from single to binary solvent combinations. The proposed method shows the efficient selection of single, binary, and ternary solvent systems with the optimal crystallization operating conditions to achieve the desired objectives. However, the change from binary to ternary system of solvents did not have a significant effect on the performance functions. The study on the crystallization process of a polymorphic transformation phenomenon is another part of the project which was modeled and optimized. The novel method of modeling for polymorphic transformation of L-glutamic acid enabled us to develop an optimal control strategy of the system consisting of a variety of process conditions (such as seeded and un-seeded crystallization). The outcome of this part of the project gives a detailed understanding of polymorphic transformation systems with optimal conditions that can be implemented for such processes. Finally some useful experimental work that has been done in the area of nucleation and polymorphic transformation of L-glutamic acid using a powerful spectroscopic probe (Lasentec FBRM) will be explained. The nucleation detection and the change from metastable polymorph to the stable one can be performed using the in-situ FBRM which was used in this project.
Continuous Manufacturing of Pharmaceuticals
Continuous Manufacturing of Pharmaceuticals - 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 Continuous Manufacturing of Pharmaceuticals write by Peter Kleinebudde. This book was released on 2017-09-05. Continuous Manufacturing of Pharmaceuticals available in PDF, EPUB and Kindle. 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.
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.
Optimization Modeling and Variation Reduction in a Pharmaceutical Production Process by Quality Engineering and Robust Design
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.
Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture
Process Simulation and Data Modeling in Solid Oral Drug 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 Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture write by Marianthi G. Ierapetritou. This book was released on 2016-08-23. Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture available in PDF, EPUB and Kindle. This thorough volume aims to provide pharmaceutical engineers with an introduction to the current state of the art in modeling and simulation of pharmaceutical processes and to summarize a number of practical applications of relevant methodologies in drug product development. Chapters include explorations of simulation and modeling methodologies, data collection and analysis, development of novel sensing techniques, development and integration of individual unit models, optimization approaches for data-based models, design space evaluation techniques, informatics-based methodologies, and emerging topics in pharmaceutical process development. As a part of the Methods in Pharmacology and Toxicology series, the chapters contain the kind of detail and implementation advice that will make the transition into the laboratory as smooth as possible. Authoritative and cutting edge, Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture seeks to promote research into process systems methodologies and their application in pharmaceutical product and process development, which will undoubtedly become an increasingly important area in the future.
