Clean Room Standards
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Cleanroom Technology
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)
Clean Room Standards
Clean Room Standards explores the critical world of controlled environments. It focuses on clean room technology and the stringent standards that govern their operation across industries like pharmaceutical and electronic manufacturing. The book delves into the ISO 14644 series, which dictates cleanliness levels, and highlights the importance of HEPA and ULPA filters in maintaining air purity. Understanding these standards is vital, as inconsistencies can lead to product recalls and harm to consumers. The book takes a systematic approach, starting with fundamental principles and then moves into specific requirements for various sectors. It emphasizes practical implementation over theoretical concepts. Case studies and examples are used to illustrate key concepts and challenges. It highlights contamination control, filtration systems, and cleanliness levels required for different manufacturing processes. The book progresses through sections detailing ISO standards, sector-specific needs, and the role of filtration. It concludes with validation and monitoring procedures. This makes the book a valuable resource for manufacturing engineers and quality assurance professionals seeking to ensure regulatory compliance and high-quality product output while navigating the complexities of clean room technology.
Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms
Author: Zhonglin Xu
language: en
Publisher: Springer Science & Business Media
Release Date: 2013-10-10
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.