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Iso 14698 1 A Complete Guide 2020 Edition
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Author :United States. Food and Drug Administration. Division of Microbiology Publisher : ISBN 13 : Total Pages :180 pages Book Rating :4.F/5 ( download)
Book Synopsis Bacteriological Analytical Manual by : United States. Food and Drug Administration. Division of Microbiology
Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Stem Cell Production by : Firdos Alam Khan
Download or read book Stem Cell Production written by Firdos Alam Khan and published by Springer Nature. This book was released on 2022-03-29 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. The initial chapter of the book discusses the therapeutic potentials of stem cells for the treatment of various diseases, including degenerative disorders and genetic diseases. The book then reviews the recent developments in the cultivation of stem cells in bioreactors, including critical cultural parameters, possible bioreactor configuration and integrations of novel technologies in bioprocess developmental stages. The book also introduces microscopic, molecular, and cellular techniques for characterization of stem cells for regulatory approvals. Further, it describes optimal cell transporting conditions to maintain cell viability and properties. Further, it summarizes characterization strategies of clinical grade stem cells for stem cell therapy. This book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.
Book Synopsis Materials for Medical Application by : Robert B. Heimann
Download or read book Materials for Medical Application written by Robert B. Heimann and published by Walter de Gruyter GmbH & Co KG. This book was released on 2020-08-24 with total page 637 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives an introduction to the highly interdisciplinary field of biomaterials. It concisely summarizes properties, synthesis and modification of materials such as metals, ceramics, polymers or composites. Characterization, in vitro and in vivo testing as well as a selection of various applications are also part of this inevitable guide.
Book Synopsis Quality Management in the Assisted Reproduction Laboratory by : Da Li
Download or read book Quality Management in the Assisted Reproduction Laboratory written by Da Li and published by Springer Nature. This book was released on 2024-01-09 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides readers up-to-date information on various aspects affecting assisted reproduction laboratories and corresponding management approaches, based on latest literatures, clinical practice, and international consensus. Key points of laboratory environment, laboratory operations and quality control measures are presented in details. Last but not least, ethical issues and countermeasures of assisted reproductive technology are discussed. It will be a practical and reader-friendly resource to help reproductive medicine practitioners establish a disciplined risk and control system for assisted reproduction laboratories and techniques.
Book Synopsis Bergey's Manual of Systematic Bacteriology by : David R. Boone
Download or read book Bergey's Manual of Systematic Bacteriology written by David R. Boone and published by Springer Science & Business Media. This book was released on 2012-01-13 with total page 717 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bacteriologists from all levels of expertise and within all specialties rely on this Manual as one of the most comprehensive and authoritative works. Since publication of the first edition of the Systematics, the field has undergone revolutionary changes, leading to a phylogenetic classification of prokaryotes based on sequencing of the small ribosomal subunit. The list of validly named species has more than doubled since publication of the first edition, and descriptions of over 2000 new and realigned species are included in this new edition along with more in-depth ecological information about individual taxa and extensive introductory essays by leading authorities in the field.
Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author :European Directorate for the Quality of Medicines & Healthcare Publisher : ISBN 13 :9789287176394 Total Pages :320 pages Book Rating :4.1/5 (763 download)
Book Synopsis Guide to the Quality and Safety of Tissues and Cells for Human Application by : European Directorate for the Quality of Medicines & Healthcare
Download or read book Guide to the Quality and Safety of Tissues and Cells for Human Application written by European Directorate for the Quality of Medicines & Healthcare and published by . This book was released on 2013-10-11 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types
Book Synopsis Hugo and Russell's Pharmaceutical Microbiology by : Brendan F. Gilmore
Download or read book Hugo and Russell's Pharmaceutical Microbiology written by Brendan F. Gilmore and published by John Wiley & Sons. This book was released on 2023-01-05 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hugo & Russell’s Pharmaceutical Microbiology Discover the very latest developments in pharmaceutical microbiology in the 9th edition of this popular textbook Microbiology is one of the essential pharmaceutical sciences upon which the study and practice of pharmacy is built. It has a bearing on all aspects of the manufacture of medicines and sterile products, from their design and development to their delivery as quality products. Few interventions are more central to modern medicine than the treatment of infection, where antibiosis, vaccination and hygienic practices have essential roles to play. The COVID-19 pandemic, the appearance of new pathogens and the rise of antibiotic resistance have demonstrated most completely the need for pharmaceutical practitioners, researchers and industrial scientists to be fully conversant with this field. The 9th edition of Hugo and Russell’s Pharmaceutical Microbiology has been updated to meet this need. Having long served as the sole comprehensive textbook covering this subject, it has now been adapted to a critical new period in the advancement of medical and pharmaceutical research and development. Its experienced editors have incorporated contributions from subject experts and created a text which will serve the next generation of pharmacy students, pharmaceutical industry scientists and researchers. In this ninth edition of Hugo and Russell’s Pharmaceutical Microbiology, readers will find: A mix of established and new authors bringing practical and research experience to their chapters Material covering the fundamentals of microbiology, microbial behavior and laboratory investigation Revised chapters incorporating new material on microbe-host interactions, antibiotic resistance, emerging pathogens, public health microbiology, healthcare-associated infection and pharmaceutical manufacture Emerging understandings from the COVID-19 pandemic on infection prevention and control and vaccine development Practitioners providing their insights on clinical practice and pharmaceutical production An accompanying website incorporating teaching resources Hugo and Russell’s Pharmaceutical Microbiology, 9th edition promises to remain the essential text for pharmacy and medical students, as well as researchers and industry professionals.
Book Synopsis Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle
Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 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 GMP in Practice written by Vesper and published by David Horwood International Pub Limited. This book was released on 2000-07 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Decontamination in Hospitals and Healthcare by : James T. Walker
Download or read book Decontamination in Hospitals and Healthcare written by James T. Walker and published by Woodhead Publishing. This book was released on 2019-11-26 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decontamination in Hospitals and Healthcare, Second Edition, enables users to obtain detailed knowledge of decontamination practices in healthcare settings, including surfaces, devices, clothing and people, with a specific focus on hospitals and dental clinics. - Offers in-depth coverage of all aspects of decontamination in healthcare - Examines the decontamination of surgical equipment and endoscopes - Expanded to include new information on behavioral principles in decontamination, control of microbiological problems, waterborne microorganisms, pseudomonas and the decontamination of laundry
Book Synopsis Cultural Heritage and Aerobiology by : Paolo Mandrioli
Download or read book Cultural Heritage and Aerobiology written by Paolo Mandrioli and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aerobiology is the science that studies the biological component of the atmosphere and its effects on living systems and on the environment. This term was used for the first time in 1935, but the attention of scientists to the biological component of the atmosphere goes back to 1769, when the Italian biologist Spallanzani carried out a series of experiments that disproved the concept of spontaneous generation of life and proved the presence of viable microorganisms in the air. Aerobiology has marked characteristics of interdisciplinarity: its application fields range from respiratory diseases to the airborne outbreak of animal and vegetal diseases and to the biodegradation of substances and materials. The latter is the subject of this book. The purpose of aerobiological research applied to the conservation of cultural heritage is to evaluate the risk of alteration by airborne microorganisms of materials forming artefacts of historical, artistic and archaeological interest. Airborne spores and vegetative structures may develop on different substrates and may be a cause of degradation, in relation to the types of materials, the microclimatic situation and the pollution of the conservation environments. The qualitative and quantitative evaluation of the biological component of air, performed by means of targeted analysis campaigns, and of the characteristics of materials and environments, supplies indispensable information for the evaluation of the actual risk and the planning of interventions. This book is divided into four main parts.
Book Synopsis Towards Sustainable Global Food Systems by : Ruerd Ruben
Download or read book Towards Sustainable Global Food Systems written by Ruerd Ruben and published by MDPI. This book was released on 2019-04-30 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the major knowledge challenges in the domain of Resilient and Sustainable Food Systems refers to the integration of perspectives on consumption, patterns that support public health, inclusive value chains, and environmentally sustainable food production. While there is a long record of the analysis of separate interventions, this special issue generates integrated insights, provides cross-cutting perspectives, and outlines practical and policy solutions that address these global challenges.The collection of papers promotes the view that sustainable food systems require thorough insights into the structure and dynamics of agri-food production systems, the drivers for integrating food value chains and markets, and key incentives for supporting healthier consumer choices. On the production side, potential linkages between agricultural commercialization and intensification and their effects for food security and nutritional outcomes are analyzed. Value Chains are assessed for their contribution to improving exchange networks and markets for food products that simultaneously support efficiency, circularity, and responsiveness. Individual motives and market structures for food consumption need to be understood in order to be able to outline suitable incentives to enhance healthy dietary choice.The contributed papers focus on interfaces between food system activities and processes of adaptive change that are critical for overcoming key constraints and trade-offs between sustainable food and healthy diets.
Book Synopsis Compounding Sterile Preparations by : E. Clyde Buchanan
Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by ASHP. This book was released on 2009-02-01 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.
Book Synopsis Sterile Drug Products by : Michael J. Akers
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
Book Synopsis Cleanroom Technology by : William Whyte
Download or read book Cleanroom Technology written by William Whyte and published by John Wiley & Sons. This book was released on 2010-03-01 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination… This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme. Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries. William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology. A comment on the first edition: "...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)
