Air Flow Visualization Techniques and Technology: How to Avoid Common Mistakes and Misunderstandings Related to Smoke Studies

摘要

1. Understanding airflow patterns in cleanrooms and controlled environments is an important aspect in contamination control. Personnel, equipment and material flow can influence airflow and affect contamination levels in even the most well designed cleanrooms. 2. Air Flow Visualization (AFV) studies, sometimes referred to as "Smoke Studies" are useful in providing a visual representation of air flow in cleanrooms. These studies (or series of tests) can also be useful in troubleshooting cleanroom contamination issues resulting from undetected air patterns that limit a cleanrooms ability to provide adequate contamination control. 3. Though considered an optional test as listed in the international cleanroom standard, "ISO 14644-3:2005, Airflow Visualization is an expected test by pharmaceutical inspection authorities and mentioned in FDA, PIC/S and USP guidance documents. 4. The criticality of airflow must not be understated when considering critical operations such as aseptic manufacturing. Because of this, the type of equipment and material used in creating the airflow visualization vapor, fog or smoke is as important as the techniques used. 5. Improperly conducted air flow visualization studies or the use of equipment and techniques that may not be suitable for conducting these studies may lead to a misleading conclusions related to airflow in critical areas. 6. Various pharmaceutical inspection authorities have specific expectations related to Smoke Studies. 7. This presentation will discuss the various methods and techniques of air flow visualization as well as provide examples of improperly tested facilities including FDA 483 Observations and warning letters related to airflow visualization.