AIR FLOW VISUALIZATION STUDIES IN CLEAN ROOMS
“Air flow visualization studies are intended to demonstrate visual evidence of air flow direction. The test helps to identify stagnant areas within a clean room; these areas can further act as a channel or reservoir of contaminants. The test can also be used to demonstrate the effects on airflow caused by equipment”.
FDA’s Inspectional Observations (483’s) on Air Flow Pattern Visualization
1.Smoke studies in ISO 5 hoods were not conducted under dynamic conditions.
2. There has been no air flow pattern (i.e smoke study) evaluation study performed to determine the acceptability of the horizontal air flow, that is, the air flow is not compromised (i.e air turbulence/air eddies) during the aseptic operations that are performed in the ISO-5 area.
3. There has been no air flow pattern evaluation to determine that the personnel activities and manual transfer of materials between the ISO-8 and ISO-7 areas negatively affect the air movement and air cascade.
4. Smoke studies have not been properly documented for the air flow patterns of the ISO 6 class rooms or ISO 5 laminar air flow hoods used in the processing of injectable products.
5. The air flow pattern video does not present data to adequately assess the requested “downward sweeping air flow pattern” for the ISO 5 aseptic fill zone. The firm failed to evaluate the potential product impact of the turbulence, air eddies observed in the middle of the ISO 5 hoods during dynamic operations.
6.Smoke study did not include an evaluation of the personnel activities performed in the adjacent ISO 5 hoods to determine that the personnel activities do not negatively affect air flow patterns within ISO 5 hoods.
7. The smoke study does not demonstrate critical aseptic connections performed during the assembly of ISO 5 hoods used to fill sterile pharmaceuticals.