Airflow Visualization for Cleanrooms and Hoods
EOC1 offers airflow visualization for your controlled environment. This testing is more commonly known as smoke testing or smoke studies. Unlike theatrical foggers and smoke sticks, EOC1 uses smoke generators that are highly controllable for accurate visualization of the smoke patterns. Cheaper non-specific smoke generators are not controllable and may create too much smoke that mask airflow issues.
Smoke studies rely on visual smoke generated in cleanrooms and hoods that allows for observation of airflow patterns. The visual smoke must be neutrally buoyant and mimic ambient air. Specific standards and guidelines are provided by the USP and FDA. Smoke visualization of uniform air in sterile manufacturing has been required for years and with the advent of USP <797> in 2008, sterile compounding in the healthcare arena is becoming the standard.
USP Chapter <797> states:
“The airflow in the PEC shall be unidirectional (laminar flow) and because of the particle collection efficiency of the filter, the first air at the face of the filter is, for the purpose of aseptic compounding, free from airborne particulate contamination. HEPA-filtered air shall be supplied in critical areas (ISO Class 5) at a velocity sufficient to sweep particles away from the compounding area and maintain unidirectional airflow during operations. Proper design and control prevents turbulence and stagnant air in the critical area. In situ air pattern analysis via smoke studies shall be conducted at the critical area to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions.”