Continuous Biomanufacturing

Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.

CONTINUOUS EMISSION MONITORING The new edition of the only single-volume reference on both the regulatory and technical aspects of U.S. and international continuous emission monitoring (CEM) systems Continuous Emission Monitoring presents clear, accurate, and up-to-date information on the technical and regulatory issues that affect the design, application, and certification of CEM systems installed in power plants, cement plants, pulp and paper mills, smelters, and other stationary sources. Written by an international expert in the field, this classic reference guide covers U.S. and international CEM regulatory requirements, analytical techniques, operation and maintenance of CEM instrumentation, and more. The fully revised Third Edition remains the most comprehensive source of CEM information available, featuring three brand-new chapters on mercury monitoring, the reporting and ­certification of industrial greenhouse gas emissions, and the instrumentation and methods used to measure air toxic compounds including dioxins, furans, and hydrogen chloride. Thoroughly updated chapters discuss topics such as flow rate monitors, new EPA regulations, instrumentation and calibration techniques, CEM system control and data acquisition, and extractive system design. Providing environmental professionals with the knowledge of CEM systems necessary to address the present-day regulatory environment, Continuous Emission Monitoring: Discusses how CEM systems work, their advantages and limitations, and the regulatory requirements governing their operation Covers both the historical framework and technological basis of current CEM regulatory programs and standards in the United States, Canada, Europe, and Asia Offers practical guidance on sampling system selection, measurement techniques, advanced monitoring approaches, recordkeeping, and quality assurance Provides detailed technical descriptions of the technology necessary for regulatory compliance Includes new orthographic drawings to help instrument technicians and regulators with little technical background to easily understand key topics Continuous Emission Monitoring, Third Edition is an essential resource for professionals responsible for ensuring regulatory compliance, managers and technicians who purchase, operate, and maintain CEM instrumentation, regulatory personnel who write and enforce operating permits, and instructors and students in upper-level environmental engineering programs.

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.

Automated Continuous Process Control pulls together–in one compact and practical volume–the essentials for understanding, designing, and operating process control systems. This comprehensive guide covers the major elements of process control in a well-defined and ordered framework. Concepts are clearly presented, with minimal reliance on mathematical equations and strong emphasis on practical, real-life examples. Beginning with the very basics of process control, Automated Continuous Process Control builds upon each chapter to help the reader understand and efficiently practice industrial process control. This complete presentation includes: A discussion of processes from a physical point of view Feedback controllers and the workhorse in the industry–the PID controller The concept and implementation of cascade control Ratio, override (or constraint), and selective control Block diagrams and stability Feedforward control Techniques to control processes with long dead times Multivariable process control Applicable for electrical, industrial, chemical, or mechanical engineers, Automated Continuous Process Control offers proven process control guidance that can actually be used in day-to-day operations. The reader will also benefit from the companion CD-ROM, which contains processes that have been successfully used for many years to practice tuning feedback and cascade controllers, as well as designing feedforward controllers.

This title considers the special of random processes known as semi-Markov processes. These possess the Markov property with respect to any intrinsic Markov time such as the first exit time from an open set or a finite iteration of these times. The class of semi-Markov processes includes strong Markov processes, L?vy and Smith stepped semi-Markov processes, and some other subclasses. Extensive coverage is devoted to non-Markovian semi-Markov processes with continuous trajectories and, in particular, to semi-Markov diffusion processes. Readers looking to enrich their knowledge on Markov processes will find this book a valuable resource.

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Continuous media streaming systems will shape the future of information infrastructure. The challenge is to design systems and networks capable of supporting millions of concurrent users. Key to this is the integration of fault-tolerant mechanisms to prevent individual component failures from disrupting systems operations. These are just some of the hurdles that need to be overcome before large-scale continuous media services such as video-on-demand can be deployed with maximum efficiency. The author places the subject in context, drawing together findings from the past decade of research whilst examining the technology’s present status and its future potential. The approach adopted is comprehensive, covering topics – notably the scalability and fault-tolerance issues – that previously have not been treated in depth. Provides an accessible introduction to the technology, presenting the basic principles for media streaming system design, focusing on the need for the correct and timely delivery of data. Explores the use of parallel server architectures to tackle the two key challenges of scalability and fault-tolerance. Investigates the use of network multicast streaming algorithms to further increase the scalability of very-large-scale media streaming systems. Illustrates all findings using real-world examples and case studies gleaned from cutting-edge worldwide research. Combining theory and practice, this book will appeal to industry specialists working in content distribution in general and continuous media streaming in particular. The introductory materials and basic building blocks complemented by amply illustrated, more advanced coverage provide essential reading for senior undergraduates, postgraduates and researchers in these fields.

This book contains more than 150 problems and solutions on the control of linear continuous systems. The main definitions and theoretical tools are summarized at the beginning of each chapter, after which the reader is guided through the problems and how to solve them. The author provides coverage of the ideas behind the developments of the main PID tuning techniques, as well as presenting the proof of the Routh–Hurwitz stability criterion and giving some new results dealing with the design of root locus.