Advances in Cleanroom Technology

By William Whyte.
ISBN: 978-0-9956666-6-5 (Hb)

This book is based on the author's work that has been published over the last sixteen years to advance knowledge of cleanroom technology.
The author, Bill Whyte, is an international authority on cleanrooms with over 50 years of experience in designing, testing, and running cleanrooms. This book is over 500 pages in length and divided into sections that group Dr Whyte's scientific writings. The topics include the history of cleanrooms and operating theatres, risk management and risk assessment methods, contamination of products, ventilation design of nonunidirectional airflow cleanrooms, and standard of cleanrooms required for specified product contamination.

In addition, the book provides further new information on measuring air supply volumes and air velocities, ventilation effectiveness, Computational Fluid Dynamics (CFD), high-efficiency air filters, decay of airborne contamination, collection efficiencies of sampling methods, airborne dispersion of particles and MCPs from people, dispersion from floors, transfer of surface contamination, and surface deposition of contamination.

Each of the seven sections is provided with a helpful introduction explaining the background to the research and summarising the key points. Overall, this book will prove very useful to anyone involved in any aspects of the design, testing and operation of cleanrooms.

Section 1: The history of cleanrooms and operating theatres, and reviews of airborne infection in hospital operating rooms.

1. The development of cleanroom technology (1865-1965). Whyte W (2008).
2. The effect of mechanical ventilation and clothing on airborne microbes and wound sepsis in hospital operating rooms, Part 1. W Whyte (2015).
3. The effect of mechanical ventilation and clothing on airborne microbes and wound sepsis in hospital operating rooms, Part 2. Whyte W (2015).
 
Section 2: Risk management and risk assessment of sources of contamination in cleanrooms

4. A cleanroom contamination control system. Whyte W (2002).
5. Operating a cleanroom: managing the risk from contamination. Whyte W (2010).
6. Microbial contamination models for use in risk assessment during pharmaceutical production. Whyte W and Eaton T (2004).
7. Microbial risk assessment in pharmaceutical. Whyte W and Eaton T (2004).
8. Assessing microbial risk to patients from aseptically manufactured pharmaceuticals. 9. Whyte W and Eaton T (2004).
10. Assessment of degree of risk from sources of microbial contamination in cleanrooms; 1: Airbourne. Whyte W and Eaton T (2015)
11. Assessment of degree of risk from sources of microbial contamination in cleanrooms; 2: Surfaces and liquids. Whyte W and Eaton T (2015).
12. Assessment of degree of risk from sources of microbial contamination in cleanrooms; 3: Overall application. Whyte W and Eaton T (2017).

Section 3: Measurement of air supply volumes and velocities, ventilation effectiveness, prediction of airflow in a cleanroom, and removal efficiencies of MCPs by air filters

13. The measurement of air supply volumes and velocities in cleanrooms. Part 1: Supply air volumes. Whyte W, Whyte WM, and Green G (2011).
14. The measurement of supply air volumes and velocities in cleanrooms. Part 2: Anemometer readings at the filter face. Whyte W, Whyte WM, and Green G (2011).
15. Experimental and CFD airflow studies of a cleanroom with special respect to air supply inlets. Whyte W, Hejab M, Whyte WM and Green G (2010).
16. Removal efficiency of high-efficiency air filters against microbe-carrying particles (MCPs) in cleanrooms. Whyte W, Green G and Whyte WM (2013).

Section 4: Calculation of the airborne concentration of contamination and required air supply rates in non-UDAF cleanrooms

17. The application of the ventilation equations to cleanrooms - Part 1: The equations. Whyte W, Whyte WM and Eaton T (2012).
18. The application of the ventilation equations to cleanrooms - Part 2: Decay of contamination. Whyte W, Ward S, Whyte WM and Eaton T (2014).
19. Decay of airborne contamination and ventilation effectiveness of cleanrooms. Whyte W, Ward S, Whyte, WM and Eaton T (2014)
20. Calculation of air supply rates for non-unidirectional airflow cleanrooms. Whyte W, Whyte WM, Eaton T and Lenegan N (2014)
21. Equations for predicting airborne cleanliness in non-unidirectional airflow cleanrooms. Whyte W, Lenegan W and Eaton T (2016).
22. Calculation of airborne cleanliness and air supply rate for non-unidirectional airflow cleanrooms. Whyte W, Lenegan N and Eaton T (2016).
23. Ensuring the air supply rate to a cleanroom complies with the EU GGMP and ISO 14644-3 recovery rate requirements. Whyte W, Lenegan N and Eaton T (2016).
24. Calculation of air supply rates and concentrations of airborne contamination in non-UDAF clean‑rooms. Whyte W, Eaton T, Whyte WM, Lenegan N, Ward S and Agricola,(2017)

Section 5: Assessment and validation of microbial sampling methods

25. Collection efficiency of microbial methods used to monitor cleanrooms. Whyte W (2005).
26. Collection efficiency and design of microbial air samplers. Whyte W, Green G and Albisu A (2007).
27. Airborne microbial monitoring in an operational cleanroom using an instantaneous detection system and high-efficiency microbial samplers. Eaton T, Davenport C and Whyte W (2012).

Section 6: Contamination in cleanrooms: dispersion from people and floors, transfer between surfaces, and deposition from air

28. Particle and microbial airborne dispersion from people. Whyte W and Hejab M (2007)
29. Letter to the Editor. Whyte W, Eaton T, Farquharson G, Ljungqvist B and Reinmüller B (2007).
30. Dispersion of microbes from floors when walking in ventilated rooms. Whyte W, Whyte WM, Blake S and Green G (2013).
32. Microbial transfer by surface contact in cleanrooms. Whyte W and Eaton T (2015).
Deposition velocities of airborne microbe carrying particles. Whyte W and Eaton T (2015).

Section 7: Deposition of airborne particles onto cleanroom surfaces

33. Airborne particle deposition in cleanrooms: Deposition mechanisms. Whyte W, Agricola K and Derks M (2015).
34. Airborne particle deposition in cleanrooms: Relationship between deposition rate and airborne concentration. Whyte W, Agricola K and Derks M (2016).
35. Airborne particle deposition in cleanrooms: Calculation of product contamination and required cleanroom class. Whyte W, Agricola K and Derks M (2016).