Environmental Monitoring for Cleanrooms and Controlled Environments PDF Download
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Author: Anne Marie Dixon
Publisher: CRC Press
ISBN: 1420014854
Category : Medical
Languages : en
Pages : 254
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Book Description
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response
Author: Anne Marie Dixon
Publisher: CRC Press
ISBN: 1420014854
Category : Medical
Languages : en
Pages : 254
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Book Description
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response
Author: Tim Sandle
Publisher: Elsevier
ISBN: 0443216010
Category : Medical
Languages : en
Pages : 510
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Book Description
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
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
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: William Whyte
Publisher: John Wiley & Sons
ISBN: 0470748060
Category : Technology & Engineering
Languages : en
Pages : 382
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Book Description
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)
Author: Claude Amiard-Triquet
Publisher: Academic Press
ISBN: 0128011769
Category : Science
Languages : en
Pages : 519
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Book Description
Aquatic Ecotoxicology: Advancing Tools for Dealing with Emerging Risks presents a thorough look at recent advances in aquatic ecotoxicology and their application in assessing the risk of well-known and emerging environmental contaminants. This essential reference, brought together by leading experts in the field, guides users through existing and novel approaches to environmental risk assessment, then presenting recent advances in the field of ecotoxicology, including omics-based technologies, biomarkers, and reference species. The book then demonstrates how these advances can be used to design and perform assays to discover the toxicological endpoints of emerging risks within the aquatic environment, such as nanomaterials, personal care products, PFOS and chemical mixtures. The text is an invaluable reference for any scientist who studies the effects of contaminants on organisms that live within aquatic environments. - Provides the latest perspectives on emerging toxic risks to aquatic environments, such as nanomaterials, pharmaceuticals, chemical mixtures, and perfluorooctane sulfonate (PFOS) - Offers practical guidance on recent advances to help in choosing the most appropriate toxicological assay - Presents case studies and information on a variety of reference species to help put the ecotoxicological theory into practical risk assess
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 48
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Book Description
A central resource of technology and methods for environments where the control of contamination is critical.
Author: Mark J. Jackson
Publisher: Springer Science & Business Media
ISBN: 0387270264
Category : Medical
Languages : en
Pages : 595
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Book Description
Medical devices and surgical tools that contain micro and nanoscale features allow surgeons to perform clinical procedures with greater precision and safety while monitoring physiological and biomechanical parameters more accurately. While surgeons have started to master the use of nanostructured surgical tools in the operating room, this book addresses for the first time the impact and interaction of nanomaterials and nanostructured coatings in a comprehensive manner. Surface Engineered Surgical Tools and Medical Devices presents the latest information and techniques in the emerging field of surface engineered biomedical devices and surgical tools, and analyzes the interaction between nanotechnology, nanomaterials, and tools for surgical applications. Chapters of the book describe developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. Chapters are also dedicated to the performance of surgical tools and dental tools and describe how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body.
Author: Dr. Tim Sandle
Publisher: Grosvenor House Publishing
ISBN: 178148080X
Category : Health & Fitness
Languages : en
Pages : 284
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Book Description
The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.
Author: Zhonglin Xu
Publisher: Springer Science & Business Media
ISBN: 3642393748
Category : Technology & Engineering
Languages : en
Pages : 885
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Book Description
Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms sets up the theoretical framework for cleanrooms. New ideas and methods are presented, which include the characteristic index of cleanrooms, uniform and non-uniform distribution characteristics, the minimum sampling volume, a new concept of outdoor air conditioning and the fundamentals of leakage-preventing layers. Written by an author who can look back on major scientific achievements and 50 years of experience in this field, this book offers a concise and accessible introduction to the fundamentals of air cleaning technology and its application. The work is intended for researchers, college teachers, graduates, designers, technicians and corporate R&D personnel in the field of HVAC and air cleaning technology. Zhonglin Xu is a senior research fellow at China Academy of Building Research.
Author: Bhavan (Bob) Mehta
Publisher: Quality Press
ISBN: 1953079105
Category : Technology & Engineering
Languages : en
Pages : 114
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Book Description
The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015. This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.
