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
Автор: Haider, Syed Imtiaz (gulf Pharmaceutical Industries, United Arab Emirates) Название: Cleaning validation manual ISBN: 1138749710 ISBN-13(EAN): 9781138749719 Издательство: Taylor&Francis Рейтинг: Цена: 117390.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors` more than two decades of experience, the text offers hands-on training based on current approaches
Автор: Haider, Syed Imtiaz Название: Validation Standard Operating Procedures ISBN: 0367390779 ISBN-13(EAN): 9780367390778 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Нет в наличии. Описание: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
Название: Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices ISBN: 0367398265 ISBN-13(EAN): 9780367398262 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The Handbook of Microbiological Quality Control provides a unique distillation of material by providing a wealth microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. The book provides guidance on safe microbiological practices, including laboratory design and sampling techniques, and considers the design storage, use and quality control of microbiological culture in depth. All the chapters have been written by leading experts in this field, making the Handbook the essential reference source for the professional microbiologist.
Автор: Mathiowitz Название: Bioadhesive Drug Delivery Systems ISBN: 0824719956 ISBN-13(EAN): 9780824719951 Издательство: Taylor&Francis Рейтинг: Цена: 224570.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Presents a review of the basic methods for characterizing bioadhesive materials and improving vehicle targeting and uptake. This book discusses chemical bonding, polymer-mucus interactions, and the effect of surface energy in bioadhesion. It is suitable for pharmaceutical scientists, biochemists, and physical, surface, and colloid chemists.
Автор: Burdick Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 3319501844 ISBN-13(EAN): 9783319501840 Издательство: Springer Рейтинг: Цена: 79190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities.
Автор: Liu Название: Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development ISBN: 1118662318 ISBN-13(EAN): 9781118662311 Издательство: Wiley Рейтинг: Цена: 171020.00 T Наличие на складе: Поставка под заказ. Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
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.
Автор: Merkus Название: Particles and Nanoparticles in Pharmaceutical Products ISBN: 3319941739 ISBN-13(EAN): 9783319941738 Издательство: Springer Рейтинг: Цена: 107130.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This edited volume brings together the expertise of numerous specialists on the topic of particles - their physical, chemical, pharmacological and toxicological characteristics - when they are a component of pharmaceutical products and formulations.
Автор: Burdick Richard K., Leblond David J., Pfahler Lori B. Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 3319843389 ISBN-13(EAN): 9783319843384 Издательство: Springer Рейтинг: Цена: 74530.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Название: Aseptic pharmaceutical manufacturing ii ISBN: 0367401738 ISBN-13(EAN): 9780367401733 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
Автор: Niazi, Sarfaraz K. Название: Handbook of pharmaceutical manufacturing formulations, third edition ISBN: 1138103160 ISBN-13(EAN): 9781138103160 Издательство: Taylor&Francis Рейтинг: Цена: 234790.00 T Наличие на складе: Нет в наличии. Описание: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing.
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