What is the function of a smoke study in a PEC?

The function of a smoke study in a Primary Engineering Control (PEC) is to demonstrate unidirectional airflow. Smoke studies are conducted to visualize and confirm that air moves in a consistent, predictable, and controlled manner within the PEC. This is critical for maintaining a sterile environment, as it ensures that airborne contaminants are effectively carried away from the critical area where sterile compounding occurs.

During a smoke study, a harmless smoke-generating device is used to observe the airflow patterns within the PEC. By ensuring that the airflow is unidirectional, it means that clean air is effectively swept towards the compounding area without turbulence, which could introduce particles or microorganisms into the sterile workspace. This process is vital for anyone involved in sterile compounding to understand because proper airflow directly impacts the sterility of the compounded preparations.

While other factors like air filtration, humidity, and temperature are also important in the overall sterile compounding environment, they are not the primary focus of a smoke study, which is specifically aimed at assessing and confirming airflow dynamics.