Cleanroom and controlled environments require clean airflow (typically produced by HEPA or ULPA filtration). Because clean airflow is critical to contamination control, understanding, characterizing or mapping air patterns in cleanrooms or contolled environments is an important part of contamination control.
In medical product cleanrooms, the FDA, PIC/S, EMA, WHO require In-situ Air Pattern Analysis (Smoke Studies or Air Flow Visualisation) of cleanrooms and barrier systems that are expertly reviewed with written conclusions. Additionally, the studies are to be captured on video for review. 2 International cleanroom standards, cGMP guidance and 3 cleanroom testing practices indicate “Neutrally Buoyant Tracer Particles” for Air Flow Visualisation. The Tracer Particle Injection Method as defined in ISO 14644-3:2019 requires the tracer particles are not be so large that gravity causes them to diverge from following the actual air flow being observed.
Microrite’s Tracer Particle Generator system provides a cloud of Tracer Particles that are submicron (<1.0 micrometer/micron) in size and are Neutrally Buoyant. These long lasting, Neutrally Buoyant Tracer Particles are ideal for getting a visual representation of air flow patterns in cleanrooms, barrier systems and the interfaces between areas of different classifications (e.g., Grade A/ISO Class 5 and Grade B/ISO Class 7 areas).