Airflow smoke studies are used to proof aseptic conditions when manufacturing sterile products under aseptic requirements. Smoke studies are the visualization of critical airflows and demonstrate an unidirectional airflow and sweeping action above and away from the compartment during filling. Studies are performed under static and dynamic conditions.

The studies lead to a documented conclusion and include the evaluation of the impact of interventions and aseptic equipment design. A digital recording is used to provide a visual check result of each test.

A well-shaped machine design can successfully complete a static testing but only the dynamic test conditions demonstrate that the equipment, the operators interaction and the aseptic environment work together perfectly in order to maintain the required aseptic conditions.