Air Flow Visualization Study

Airflow pattern visualization provides a visual record of actual airflow patterns in a pharmaceutical facility. It is currently the most widely accepted method of demonstrating that airflow patterns in critical processing areas meet regulatory expectations. In addition, airflow pattern visualization allows multiple functional organizations to discover the effectiveness and significance of the airflow design and functionality, especially in critical areas.

KEY POINTS

The following key points are discussed:

Smoke studies, or airflow visualization tests, are a key activity in the qualification, maintenance, and monitoring of an aseptic facility Discussions of the specific methods and tech- niques to conduct and record airflow visualiza- tion are not readily available
Basic airflow characteristics for the cleanroom environment are described
Desirable airflow in a manufacturing cleanroom is unidirectional
Commercial cleanroom foggers are used in smoke studies
Pictures and video taken in the manufacturing environment must be conducted with rigorous compliance to good manufacturing practice poli- cies and procedures
Basic photographic considerations such as "white-on- white," reflections, panning, and other techniques must be addressed in filming smoke studies
Smoke studies are filled under static (at rest) and dynamic (operational) conditions Smoke studies must have specific acceptance criteria
Narration and music may be considered in pro- ducing the smoke study video
The final report must include basic information including results, discussion, and conclusions

Air Flow Visualization Study

KEY POINTS

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