Download or read book Sterile Product Facility Design and Project Management Second Edition written by Jeffrey N. Odum and published by CRC Press. This book was released on 2004-03-29 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.
Download or read book Sterile Product Facility Design and Project Management written by Jeffrey N. Odum and published by CRC Press. This book was released on 2004-03-29 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provid
Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
Download or read book Active Pharmaceutical Ingredients written by Stanley Nusim and published by CRC Press. This book was released on 2016-04-19 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
Download or read book Process Architecture in Biomanufacturing Facility Design written by Jeffery Odum and published by John Wiley & Sons. This book was released on 2018-01-26 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Download or read book Sterile Manufacturing written by SAM A. HOUT and published by CRC Press. This book was released on 2021-07-05 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA and ICH emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2015-02-13 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
Download or read book American Book Publishing Record written by and published by . This book was released on 2003 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Downstream Industrial Biotechnology written by Michael C. Flickinger and published by John Wiley & Sons. This book was released on 2013-07-17 with total page 884 pages. Available in PDF, EPUB and Kindle. Book excerpt: DOWNSTREAM INDUSTRIAL BIOTECHNOLOGY An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley’s Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biopharmaceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.
Download or read book Handbook of Validation in Pharmaceutical Processes Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Download or read book Perinatal Tissue Derived Stem Cells written by Babak Arjmand and published by Springer. This book was released on 2016-12-01 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers several aspects of perinatal tissue-derived stem cells, from theoretical concepts to clinical applications. Topics include functions and different sources, immunomodulatory properties, translational point of view, GMP facility design and manufacturing for clinical translation, therapeutic potentials, and finally ethical considerations. The text provides a brief review of each type of perinatal stem cells and then focuses on their multi- or pluripotent properties, regenerative capacity, and future therapeutic potential in regenerative medicine. Additionally, the book discusses GMP compliance in stem cell facilities and the manufacture of stem cells for clinical translation. The chapters are authored by world-renowned experts in the perinatal stem cell field. Perinatal Tissue-Derived Stem Cells: Alternative Sources of Fetal Stem Cells, part of Springer’s Stem Cell Biology and Regenerative Medicine series, is essential reading for basic and clinical scientists, clinicians, and pharmaceutical experts working or conducting research in the fields of stem cell biology, molecular aspects of stem cell research, tissue engineering, regenerative medicine, and cellular therapy.
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2023-12-18 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Download or read book The Cumulative Book Index written by and published by . This book was released on 1997 with total page 2312 pages. Available in PDF, EPUB and Kindle. Book excerpt: A world list of books in the English language.
Download or read book Subject Guide to Books in Print written by and published by . This book was released on 1997 with total page 3310 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-02-09 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. Includes the most current regulations Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy Offers practical guidance on building a complete biocontamination strategy
Download or read book The British National Bibliography written by Arthur James Wells and published by . This book was released on 2006 with total page 2492 pages. Available in PDF, EPUB and Kindle. Book excerpt:
