The presentation shows how simulation supports both regulatory compliance and engineering development in the design of cleanrooms and isolators. It explains how flow modeling contributes to quality assurance in accordance with Annex 1 and ISO 14644, and how CFD simulations of decontamination can be used to assess homogeneity and identify potential problem areas or hotspots. It also shows the influence of moving objects on air flows and the risk of contamination, and how particle tracking can be used to develop effective contamination control strategies. Aspects of environmental monitoring and the efficiency of decontamination processes are also covered.
The session provides an overview of various CFD simulation packages and links practical engineering insights with process quality, contamination control, and product safety.