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Author : Raymond K. Schneider
Publisher : Unknown
Page : 170 pages
File Size : 55,7 Mb
Release : 1995
Category : House & Home
ISBN : UOM:39015036276643
Author : William Whyte
Publisher : John Wiley & Sons
Page : 382 pages
File Size : 50,6 Mb
Release : 2010-03-01
Category : Technology & Engineering
ISBN : 9780470748060
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 : Bengt Ljungqvist,Berit Reinmuller
Publisher : Routledge
Page : 101 pages
File Size : 43,9 Mb
Release : 2018-05-04
Category : Medical
ISBN : 9781351460422
This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmüller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements
Author : W. Whyte
Publisher : John Wiley & Sons
Page : 336 pages
File Size : 48,5 Mb
Release : 1999-05-04
Category : Technology & Engineering
ISBN : STANFORD:36105023605061
This book has been written by an international body of authors working in a variety of industries including electronics, biotechnology and pharmaceuticals, who discuss the considerations to be taken into account when designing cleanrooms. Three chapters describe how cleanrooms are designed for the principal manufacturing areas of microelectronics, pharmaceutical manufacturing and biotechnology. Other subjects covered are international design standards, the economics of cleanroom design, high efficiency air filtration, materials used in cleanroom construction, and the provision of clean gases and water. A unique feature of this new edition includes the application of cleanroom design technology to a mini environment such as a bench-top.
Author : William Whyte
Publisher : John Wiley & Sons
Page : 382 pages
File Size : 48,6 Mb
Release : 2011-08-17
Category : Technology & Engineering
ISBN : 9781119965596
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 : Zhonglin Xu
Publisher : Springer Science & Business Media
Page : 871 pages
File Size : 54,8 Mb
Release : 2013-10-10
Category : Technology & Engineering
ISBN : 9783642393747
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 : Bengt Ljungqvist,Berit Reinmuller
Publisher : CRC Press
Page : 160 pages
File Size : 51,5 Mb
Release : 1996-11-30
Category : Medical
ISBN : 1574910329
This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmüller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements
Author : W. Whyte
Publisher : John Wiley & Sons
Page : 336 pages
File Size : 43,7 Mb
Release : 2001-10-17
Category : Medical
ISBN : 0471868426
This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with an introduction to this state-of-the-art technology and professionals with an accessible reference to current standards.
Author : W. J. Whitfield
Publisher : Unknown
Page : 30 pages
File Size : 50,5 Mb
Release : 1962
Category : Clean rooms
ISBN : UOM:39015094986083
This is a report on an experimental cleanroom which eliminates the need for strict personnel control, special clothing, and special operational procedures. Tests to date have shown that cleanliness levels have been achieved which are several orders of magnitude better than cleanrooms of conventional design. General design features, and the results of operational tests, are described.
Author : Gary Prager
Publisher : John Wiley & Sons
Page : 578 pages
File Size : 55,9 Mb
Release : 2018-12-18
Category : Science
ISBN : 9780470410325
A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals.
Author : Sandro C. Esteves,Alex C. Varghese,Kathryn C. Worrilow
Publisher : CRC Press
Page : 461 pages
File Size : 42,9 Mb
Release : 2016-11-18
Category : Medical
ISBN : 9781482254082
Regulatory agencies worldwide have issued directives or such requirements for air quality standards in embryology laboratories. This practical guide reviews the application of clean room technology or controlled environments specifically suited for Assisted Reproductive Technology (ART) Units. Its comprehensive coverage includes material on airborne particles and volatile organic compounds, including basic concepts, regulation, construction, materials, certification, clinical results in humans, and more.
Author : Charles Nehme
Publisher : Charles Nehme
Page : 45 pages
File Size : 53,7 Mb
Release : 2024-06-10
Category : Technology & Engineering
ISBN : 8210379456XXX
Cleanrooms have become an essential component of the pharmaceutical industry, playing a critical role in ensuring the purity and safety of life-saving medications. These rigorously controlled environments are designed to minimize the presence of airborne particles and other contaminants, protecting sensitive pharmaceutical products from microbial contamination, preventing product degradation, and maintaining product efficacy. This comprehensive guide provides a detailed and practical overview of cleanroom design, construction, operation, and maintenance, specifically tailored for pharmaceutical plants. It delves into the fundamental principles of cleanroom technology, covering topics ranging from air quality control and personnel practices to regulatory compliance and future trends. Whether you are a seasoned pharmaceutical professional or an aspiring engineer seeking to enter this specialized field, this book will equip you with the knowledge and expertise to effectively design, construct, operate, and maintain cleanrooms that meet the stringent requirements of pharmaceutical manufacturing. Key Features: Comprehensive Coverage: Provides in-depth insights into all aspects of cleanroom technology for pharmaceutical plants, from fundamental principles to practical applications. Real-World Applications: Showcases practical examples of cleanroom implementation in pharmaceutical plants, highlighting challenges, best practices, and the impact on product quality. Regulatory Compliance: Discusses the applicable regulatory guidelines and standards, ensuring adherence to Good Manufacturing Practice (GMP) requirements. Future Trends: Explores emerging trends in cleanroom technology, including innovative air filtration systems, advanced materials, and automation solutions. Target Audience: Pharmaceutical Professionals: Engineers, chemists, pharmacists, quality control specialists, and other professionals involved in the design, construction, operation, and maintenance of cleanrooms in pharmaceutical plants. Engineering Students: Students pursuing careers in pharmaceutical engineering, cleanroom technology, or related fields. Regulatory Auditors: Individuals responsible for inspecting and ensuring compliance with pharmaceutical cleanroom regulations. Contribution to the Field: This book aims to serve as a valuable resource for individuals seeking to advance their knowledge and expertise in cleanroom technology for pharmaceutical applications. It bridges the gap between theoretical concepts and practical implementation, equipping professionals with the tools to design, construct, operate, and maintain cleanrooms that consistently meet the stringent requirements of pharmaceutical manufacturing.
Author : David Conway
Publisher : Architectural Press
Page : 0 pages
File Size : 48,8 Mb
Release : 2003-04
Category : Clean rooms
ISBN : 0750657952
An essential topic for the semiconductor fabrication and electronics manufacturing industry, also relevant to electronic design engineers in microelectronics and other industry sectors that use cleanrooms, for example, pharmaceutical. This book offers an introduction to the role of cleanrooms, their use and specification, for a wide range of technicians and technical managers. products and it is for this reason that cleanrooms are becoming a regular feature of modern industry in its battle to control contamination. With the demand for higher productivity and reliability of the manufacturing process and the ever-increasing miniaturisation of equipment, cleanrooms have become integral to the success of the manufacturing process. This book will teach you how to create a cleanroom and also how to effectively operate, maintain and work within this controlled environment. This book will help you manage your cleanroom investment more efficiently, thereby increasing your productivity through greater product yields.
Author : Matts Ramstorp
Publisher : John Wiley & Sons
Page : 179 pages
File Size : 43,7 Mb
Release : 2008-07-11
Category : Science
ISBN : 9783527613137
Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. This book covers the basic principles of contamination control and cleanroom technology from a holistic point of view. It deals with cleanliness and hygiene and their effects on the outcome of a process, reflecting the latest results from both scientific and practical points of view. The following topics are covered: contaminants and how they are measured cleanrooms and clean zones cleaning and decontamination cleanroom clothing the impact of people on cleanliness. Intended as an introduction to the area of contamination control, the text is also an excellent source of knowledge for people with both theoretical and practical experience. The Swedish version has been used for a long time within the Nordic countries as a basic training textbook within the pharmaceutical, microelectronics, food and beverage, optics and many other industries.
Author : Alvin Lieberman
Publisher : Springer Science & Business Media
Page : 419 pages
File Size : 46,5 Mb
Release : 2012-12-06
Category : Technology & Engineering
ISBN : 9781468465129
Contamination control standards and techniques for all phases of the production of high-technology products are spelled out in this applications-orientated guide. Practical cleaning methods for products and process fluids are accompanied by tips on selecting operations based on economy and efficiency. Explanations of contaminant measurement devices cover operation, error sources and remedial methods. Engineers will find vital data on contaminant sources, as well as coverage of operations and procedures that aggravate contaminant effects.