The Impact of Annex 1 on Air Visualization Studies

Air visualization studies are a fundamental tool for the qualification of clean rooms and clean air devices. The use of these air flow studies made it increasingly clear that the information generated was transversal and useful in personnel training, and a component in the definition of an environmental monitoring plan. The latest edition of Annex 1 (2023) emphasizes these last two aspects, pushing for the appropriate performance of studies to generate information for these purposes. Computational Fluid Dynamic (CFD) studies and Smoke studies are the two most widely used types of air visualization studies to date, the first is used to predict airflow patterns during Quality by Design phases, and the second is to visualize airflow patterns during qualification and re-qualification phases. These studies, both in at rest and in operational state, are important for defining risks related to airflow (e.g. air turbulence) and the interference generated by operations. During this presentation, we will review the risks related to interpreting these studies, the most common doubts, and above all, how the data generated can be used for the design of the site's Contamination Control Strategy (CCS).