The qualification of the aseptic core zone and adjacent cleanroom areas is a recurring focus of audits and inspections. One of the most frequently discussed topics is the visualization of laminar airflow in the aseptic core zone. The visualization of laminar air flow is referred to as flow visualization or smoke study. The aim of the flow visualization is to verify the laminar air flow in the following operating states “At Rest”, “In Operation” and “Intervention”.
The preparation and planning of the visualization as well as the execution and subsequent interpretation of the results obtained each represent a complex set of tasks that must be carefully prepared and planned.
This presentation presents the requirements for the visualization as well as a description for the preparation and execution of the validation of laminar air flow in the aseptic core zone using the risk-based approach.