Book Review - Basic Cleanroom Technology by William Whyte
Reviewer Malcolm B Holmes C.Chem MRSC
Other more in-depth books by the same author, on this theme have previously been reviewed in this journal – see the March and September 2023 editions.
The author clearly states that this is a simpler, shorter book intended for people who have recently entered the cleanroom industry and also it provides information for educational courses. Might I also suggest it as essential reading for those who make business decisions around cleanroom operations but have little knowledge of why certain practices have to be observed.
There are thirteen chapters each covering a different aspect of clean room technology from an introduction and the applicable standards & regulations through to how to clean a cleanroom. Each chapter contains useful and clear pictures / graphics to illustrate / provide explanations to the associated text.
I found CH2, in which the author reviews the applicable standards and regulations, to be a good introduction to the complexity surrounding these aspects of operating cleanrooms. He lists the 17 published (so far) parts of the ISO14644 standard, states that the most important of these is Part 1, which is used to classify the cleanroom by its airborne cleanliness. Then if 17 Parts are not enough to concern you, warns of two new ones under way (Parts 18 & 20 – no mention of 19 at this stage). Extracts from the EU and USA GMP standards for pharmaceutical clean rooms are given so the reader can see how they differ and hopefully work on how, where necessary, to be compliant with both, as well as the ISO standard.
Examples of calculations and explanations behind them are given where appropriate. E.g., clearly indicating Ch3 p11, that the air change per hour does not mean the number of times /hr. that all of the room air and its airborne contamination is replaced – a common misconception.
There is a lovely observation in Ch 10 p55 on Personnel Disciplines. “Many contamination problems are caused by lack of knowledge and only people trained in the various aspects of contamination control should be allowed into a cleanroom.” How true and frequently ignored this is! This book is surely an excellent tool in facilitating such necessary training and awareness. The same chapter contains a list of temporary conditions that may be a reason for temporarily excluding personnel from clean rooms. Such a list could be valuable as a ‘neutral’ source to prevent embarrassment when having to make or request such an exclusion.
I believe that this book meets its purpose as stated by the Author. It would make a good read for people new to the cleanroom industry as well as a refresher for ‘Old Hands’. I also can see how it could easily be used to create more extensive training materials and educational courses.
In chapter 4 page 19 & p23 the author refers to “sterilisation of the inside of the RABS /isolator” I would have preferred to see the term “fumigation or vapour disinfection (e.g. Vapour-phase Hydrogen Peroxide)” as is used in Annex 1 of the EU GGMP, rather than sterilisation. This was a topic of much debate and was a potential showstopper during the very prolonged evolution of Annex1.
There are also differences (p44) from the Annex 1 definitions of the “at Rest and “operational” states of cleanrooms.
These are just ‘reminder examples’ that you always need to bear in mind any specific regulatory or product requirements that may apply to your particular operation.
This publication is available from Amazon https://amzn.eu/d/3H4qm0b