Book Review | Open Access | Published 13th October 2023
BOOK REVIEW - Cleanroom Technology Fundamentals of Design, Testing and operation (Third Edition)
Author W Whyte
Reviewers : Alisdair Fulton, Validation Manager, MicroPharm Ltd, Kay O’Hagan, Qualified Person, MicroPharm Ltd.
Bill Whyte has been writing books and publishing papers about cleanrooms (design, operation, test) for decades. This is another excellent and easy reading book on the same subjects, but updated. The book is not about any particular industry using cleanrooms, but about the working of ISO14644 cleanroom standard for any industry.
As alluded to in the book title, and by the author in the Introduction, this book provides the reader with a basic understanding of the principles of design, test, and operation of a cleanroom. It is recommended that anyone embarking on the design, testing or operation of a cleanroom read this book. Each aspect one would expect to be covered by a book with this subject matter has been included so the reader can be confident that by applying the approaches explained in the book, their cleanroom will function as intended.
The chapters are short and each one ends with a reference section which directs the reader to further information sources as required. The fact that the chapters are short means that the book becomes a valuable reference document that can be consulted when necessary. While the references are well placed with each chapter, an index and a glossary at the end would be beneficial.
Each topic is clearly explained, with historic examples and scientific justification for the approach recommended by the author. This is supported by pictures, charts, and tables as necessary to help guide the reader through points the author is making. Each chapter moves from the basic to the detailed. This makes the book applicable to both the novice and the experienced.
As expected with a book concerned with cleanroom testing, International Standard ISO 14644 ‘Cleanrooms and associated controlled environments’ is heavily referenced when describing the approach and methods for particle counting, airflow monitoring, HEPA Filter Integrity testing, pressure testing and room recovery rates.
The author reminds the readers that this is a multi-industry standard and that individual industries will have standards that differ. The cleanrooms in the pharmaceutical industry have different particle limits (both microbe-carrying and non-viable particles) depending on the country of manufacture and sale of the product. For example, EU GMP Annex 1 2022 (Manufacture of Sterile Medicinal Products) for product sold in Europe and the FDA Guidance for Industry (Sterile Drug Products Produced by Aseptic Manufacturing – current Good Manufacturing Practice) for product sold in the USA. While the particle levels may differ as above, the test methodology, the terminal supply air filter testing, pressure measurements, the construction and design are the same across the cleanroom using industries.
The first part of the book focuses on the design and testing of cleanrooms. The final part focuses on the operation of cleanrooms and in particular how they support Cleanroom Contamination Control and the risk management of the cleanroom. This includes guidance of selection and management of cleanroom clothing, test methods that can be performed on the clothing, best practice in change procedures, and cleanroom behaviours.
The guidance on cleanroom surface monitoring techniques in accordance with ISO 14644-9:2012 ‘Cleanrooms and associated controlled environments — Part 9: Classification of surface cleanliness by particle concentration’ to better understand the contamination risk to open product vessels from microbial particles was a useful addition to this reader’s understanding.
The final third of the book also reiterates statements made earlier in the book and references the specific chapter should the reader wish to refresh their memory.
Overall, an excellent book, it serves both the novice and the experienced. The book covers cleanrooms regardless of their use but does have special reference to the Pharmaceutical and Medical Device industry in Chapter 17 (Microbial Sampling).
The book explains subjects (even the calculations) in simple language, the chapters are focused and with language that makes it an easy read. This book is a very useful book to add to your or your company’s library.
Alisdair Fulton, Validation Manager, MicroPharm Ltd
Kay O’Hagan, Qualified Person, MicroPharm Ltd.