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Frans Saurwalt, Chair ICCCS

Developments in Designing with the Latest ISO14644-4

5 Dec 2024

Frans Saurwalt, Chair of the ICCCS, explores the advancements brought by the latest edition of ISO 14644-4, a standard that redefines the principles of designing, constructing, and initiating cleanrooms and controlled environments. Published at the end of 2022, this updated standard aligns closely with the holistic strategies emphasized in EU GMP Annex 1, underscoring the importance of contamination control concepts as a foundation for cleanroom design.

The revised standard introduces a more scientific methodology to the design process, moving away from traditional "rule of thumb" practices like arbitrary air change rates. Instead, it advocates for precision through equation-based design, which tailors cleanroom performance to specific contamination control needs. This shift represents a significant evolution, fostering designs that are not only more efficient but also aligned with the latest regulatory expectations.

While challenges persist - particularly in identifying the correct input parameters for these advanced calculations - the presentation highlights the progress already achieved. Real-world examples illustrate how these principles are being applied effectively, showcasing the benefits of this rigorous, science-driven approach to cleanroom design and operation.

…is a distinguished expert in contamination control, with a career spanning over 35 years. Holding a master’s degree in mechanical engineering from Delft University of Technology, he has dedicated his expertise to designing and consulting on advanced processes and facilities across sectors such as healthcare, pharmaceuticals, biotechnology, food production, and medical devices. As the technical manager at Kropman Contamination Control, Frans oversees the design, construction, commissioning, and qualification of state-of-the-art clean production facilities. 

He plays a pivotal role in international standardization efforts, serving as chairman of the Technical Committee and past chairman of the International Confederation of Contamination Control Societies (ICCCS). He has also held leadership positions within the Dutch Contamination Control Society (VCCN), where he is an honorary member. Frans contributes to the development of ISO 14644 and ISO 14698 standards through ISO TC209 and has been instrumental in drafting new hospital ventilation standards under CEN TC156. Additionally, he is a key figure in the European Hygienic Engineering & Design Group (EHEDG), chairing the Dutch chapter and contributing to guidelines on building design and air handling for hygienic food production.