A New Approach to Cleanroom Design


Book Description

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.




The Cleanroom Approach to Quality Software Development


Book Description

Describes the first practical attempt to place software development under statistical quality control and to deliver software with a known and certified meantime to failure. Shows how to improve productivity during software development using statistical design methods, and gives guidelines for writing more precise specifications, building simpler designs and avoiding error rework.




Cleanroom Design


Book Description

12. The Production and Transmission of High Purity Gases for the Semiconductor Industry / R. Galbraith -- 13. Materials for Services Pipework / T. Hodgkiess.




Cleanroom Technology


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)




Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms


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.




Cleanroom Software Engineering


Book Description

Cleanroom software engineering is a process for developing and certifying high-reliability software. Combining theory-based engineering technologies in project management, incremental development, software specification and design, correctness verification, and statistical quality certification, the Cleanroom process answers today's call for more reliable software and provides methods for more cost-effective software development. Cleanroom originated with Harlan D. Mills, an IBM Fellow and a visionary in software engineering. Written by colleagues of Mills and some of the most experienced developers and practitioners of Cleanroom, Cleanroom Software Engineering provides a roadmap for software management, development, and testing as disciplined engineering practices. This book serves both as an introduction for those new to Cleanroom and as a reference guide for the growing practitioner community. Readers will discover a proven way to raise both quality and productivity in their software-intensive products, while reducing costs. Highlights Explains basic Cleanroom theory Introduces the sequence-based specification method Elaborates the full management, development, and certification process in a Cleanroom Reference Model (CRM) Shows how the Cleanroom process dovetails with the SEI's Capability Maturity Model for Software (CMM) Includes a large case study to illustrate how Cleanroom methods scale up to large projects.




Cleanroom Software Engineering Practices


Book Description

Cleanroom Software Engineering is a set of techniques and practices for the development of software-intensive systems. This book brings together concepts, lessons learned and best practices resulting from Cleanroom projects surveyed in the past several years.




HVAC DESIGN FOR CLEAN ROOMS


Book Description

Preface Welcome to the world of cleanrooms, where precision, purity, and innovation converge to shape the cutting edge of technology and scientific advancements. This book serves as a comprehensive guide to understanding the intricate ecosystem of cleanrooms, exploring their significance, principles, and applications across various industries. Cleanrooms are meticulously controlled environments designed to minimize the presence of airborne particles, contaminants, and other impurities that could compromise the integrity of sensitive processes or products. They have become indispensable in fields such as semiconductor manufacturing, pharmaceuticals, biotechnology, aerospace, and nanotechnology, where the tiniest of particles can have far-reaching consequences. The journey into the realm of cleanrooms takes us beyond the mere realm of cleanliness. It introduces us to the concepts of particle counts, laminar flow, filtration systems, gowning protocols, and the vital role they play in ensuring the highest standards of quality, reliability, and safety. Cleanroom design, construction, and maintenance are multifaceted endeavors that require a holistic approach, incorporating engineering, materials science, microbiology, and stringent quality management practices. As we delve deeper into the chapters of this book, we will explore the fascinating history of cleanrooms and the pioneers who revolutionized their development. We will gain insights into the classification systems that define cleanliness levels and the international standards that guide their implementation. Moreover, we will uncover the essential equipment and technologies employed within cleanrooms, from high-efficiency particulate air (HEPA) filters to air showers and from isolators to anterooms. Cleanrooms are more than just controlled environments; they are crucibles for innovation and breakthrough discoveries. They provide an environment conducive to pushing the boundaries of human knowledge and achievement. We will examine their pivotal role in research and development, where scientists and engineers work tirelessly to create new materials, develop life-saving drugs, and advance technologies that shape our future. While the primary focus of this book is on the technical aspects of cleanrooms, we must not overlook the human element that makes them truly effective. The people who work within these environments, following rigorous protocols and procedures, are the guardians of cleanliness and integrity. We will highlight the importance of training, cleanroom behavior, and a strong culture of safety in ensuring optimal performance. In compiling this book, our intention is to provide a comprehensive resource for engineers, scientists, researchers, students, and anyone with an interest in cleanrooms. We aim to demystify the complexities and provide practical knowledge that will enable readers to navigate the intricacies of cleanroom design, operation, and maintenance successfully. Cleanrooms are dynamic entities that evolve with the advancements in technology and scientific understanding. By exploring the past, understanding the present, and anticipating the future, we hope to equip you with the tools to embrace the challenges and seize the opportunities that lie within these controlled environments. We invite you to embark on this enlightening journey into the world of cleanrooms, where the pursuit of excellence and purity leads to remarkable discoveries and transformational achievements. Enjoy your exploration! Charles Nehme




Clean Room Technology


Book Description




Biocontamination Control for Pharmaceuticals and Healthcare


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