Download or read book Pharmaceutical Process Modeling Optimization and Control written by Ehsan Sheikholeslamzadeh and published by . This book was released on 2013 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Optimization of Pharmaceutical Processes written by Antonios Fytopoulos and published by Springer Nature. This book was released on 2022-04-06 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Modeling and Control of Drug Delivery Systems written by Ahmad Taher Azar and published by Academic Press. This book was released on 2021-02-06 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modeling and Control of Drug Delivery Systems provides comprehensive coverage of various drug delivery and targeting systems and their state-of-the-art related works, ranging from theory to real-world deployment and future perspectives. Various drug delivery and targeting systems have been developed to minimize drug degradation and adverse effect and increase drug bioavailability. Site-specific drug delivery may be either an active and/or passive process. Improving delivery techniques that minimize toxicity and increase efficacy offer significant potential benefits to patients and open up new markets for pharmaceutical companies. This book will attract many researchers working in DDS field as it provides an essential source of information for pharmaceutical scientists and pharmacologists working in academia as well as in the industry. In addition, it has useful information for pharmaceutical physicians and scientists in many disciplines involved in developing DDS, such as chemical engineering, biomedical engineering, protein engineering, gene therapy. - Presents some of the latest innovations of approaches to DDS from dynamic controlled drug delivery, modeling, system analysis, optimization, control and monitoring - Provides a unique, recent and comprehensive reference on DDS with the focus on cutting-edge technologies and the latest research trends in the area - Covers the most recent works, in particular, the challenging areas related to modeling and control techniques applied to DDS
Download or read book Process Systems Engineering for Pharmaceutical Manufacturing written by Ravendra Singh and published by Elsevier. This book was released on 2018-03-16 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Model Based Tools for Pharmaceutical Manufacturing Processes written by Krist V. Gernaey and published by MDPI. This book was released on 2020-03-13 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Modelling Optimization and Control of Biomedical Systems written by Efstratios N. Pistikopoulos and published by John Wiley & Sons. This book was released on 2018-01-09 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Shows the newest developments in the field of multi-parametric model predictive control and optimization and their application for drug delivery systems This book is based on the Modelling, Control and Optimization of Biomedical Systems (MOBILE) project, which was created to derive intelligent computer model-based systems for optimization of biomedical drug delivery systems in the cases of diabetes, anaesthesia, and blood cancer. These systems can ensure reliable and fast calculation of the optimal drug dosage without the need for an online computer—while taking into account the specifics and constraints of the patient model, flexibility to adapt to changing patient characteristics and incorporation of the physician’s performance criteria, and maintaining the safety of the patients. Modelling Optimization and Control of Biomedical Systems covers: mathematical modelling of drug delivery systems; model analysis, parameter estimation, and approximation; optimization and control; sensitivity analysis & model reduction; multi-parametric programming and model predictive control; estimation techniques; physiologically-based patient model; control design for volatile anaesthesia; multiparametric model based approach to intravenous anaesthesia; hybrid model predictive control strategies; Type I Diabetes Mellitus; in vitro and in silico block of the integrated platform for the study of leukaemia; chemotherapy treatment as a process systems application; and more. Introduces readers to the Modelling, Control and Optimization of Biomedical Systems (MOBILE) project Presents in detail the theoretical background, computational tools, and methods that are used in all the different biomedical systems Teaches the theory for multi-parametric mixed-integer programming and explicit optimal control of volatile anaesthesia Provides an overview of the framework for modelling, optimization, and control of biomedical systems This book will appeal to students, researchers, and scientists working on the modelling, control, and optimization of biomedical systems and to those involved in cancer treatment, anaesthsia, and drug delivery systems.
Download or read book Optimization Modeling and Variation Reduction in a Pharmaceutical Production Process by Quality Engineering and Robust Design written by Andrew Dada Ezekiel and published by . This book was released on 2006 with total page 714 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture written by Marianthi G. Ierapetritou and published by Humana Press. This book was released on 2016-08-23 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book PAT Applied in Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and published by CRC Press. This book was released on 2011-12-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Business Process Management within Chemical and Pharmaceutical Industries written by Guido Grüne and published by Springer Science & Business Media. This book was released on 2013-11-08 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP’s consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants’ profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.
Download or read book Process Modelling and Simulation written by César de Prada and published by MDPI. This book was released on 2019-09-23 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-08-30 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Special Issue written by Salvador García-Muñoz and published by . This book was released on 2010 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Chemical Engineering and Chemical Process Technology Volume IV written by Ryzhard Pohorecki and published by EOLSS Publications. This book was released on 2010-11-30 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemical Engineering and Chemical Process Technology is a theme component of Encyclopedia of Chemical Sciences, Engineering and Technology Resources in the global Encyclopedia of Life Support Systems (EOLSS), which is an integrated compendium of twenty Encyclopedias. Chemical engineering is a branch of engineering, dealing with processes in which materials undergo changes in their physical or chemical state. These changes may concern size, energy content, composition and/or other application properties. Chemical engineering deals with many processes belonging to chemical industry or related industries (petrochemical, metallurgical, food, pharmaceutical, fine chemicals, coatings and colors, renewable raw materials, biotechnological, etc.), and finds application in manufacturing of such products as acids, alkalis, salts, fuels, fertilizers, crop protection agents, ceramics, glass, paper, colors, dyestuffs, plastics, cosmetics, vitamins and many others. It also plays significant role in environmental protection, biotechnology, nanotechnology, energy production and sustainable economical development. The Theme on Chemical Engineering and Chemical Process Technology deals, in five volumes and covers several topics such as: Fundamentals of Chemical Engineering; Unit Operations – Fluids; Unit Operations – Solids; Chemical Reaction Engineering; Process Development, Modeling, Optimization and Control; Process Management; The Future of Chemical Engineering; Chemical Engineering Education; Main Products, which are then expanded into multiple subtopics, each as a chapter. These five volumes are aimed at the following five major target audiences: University and College students Educators, Professional practitioners, Research personnel and Policy analysts, managers, and decision makers and NGOs.
Download or read book New Directions in Bioprocess Modeling and Control written by Michael A. Boudreau and published by ISA. This book was released on 2007 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Models offer benefits even before they are put on line. Based on years of experience, the authors reveal in New Directions in Bioprocess Modeling and Control that significant improvements can result from the process knowledge and insight that are gained when building experimental and first-principle models for process monitoring and control. Doing modeling in the process development and early commercialization phases is advantageous because it increases process efficiency and provides ongoing opportunities for improving process control. This technology is important for maximizing benefits from analyzers and control tool investments. If you are a process design, quality control, information systems, or automation engineer in the biopharmaceutical, brewing, or bio-fuel industry, this handy resource will help you define, develop, and apply a virtual plant, model predictive control, first-principle models, neural networks, and multivariate statistical process control. The synergistic knowledge discovery on bench top or pilot plant scale can be ported to industrial scale processes. This learning process is consistent with the intent in the Process Analyzer and Process Control Tools sections of the FDA_s Guidance for Industry PAT _ A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. It states in the Process Analyzer section of the FDA_s guidance: _For certain applications, sensor-based measurements can provide a useful process signature that may be related to the underlying process steps or transformations. Based on the level of process understanding these signatures may also be useful for the process monitoring, control, and end point determination when these patterns or signatures relate to product and process quality._
