Microrite Tracer Particle Generator System

Tracer Particle Generator System TPG-M1:

The calibrated Tracer Particle Generator system produces Neutrally Buoyant, long lasting, submicron Tracer Particles for accurate airflow visualization in cleanrooms and controlled environments.

The TPG M1 includes

1. A high output Cleanroom Vaporizer which creates a sterile vapor with no combustion by products
2. 2.Extremely low vapor pressure Tracer Particle Solution for a long lasting visible fog
3. A fully configurable Diffuser Manifold System that converts the vapor into a stable tracer particle at atmospheric temperature and pressure

Cleanroom and controlled environments require clean air flow (typically produced by HEPA or ULPA filtration). Because clean air flow is critical to contamination control, understanding, characterizing or mapping air patterns in cleanrooms or controlled environments is an important part of contamination control.

In medical product cleanrooms, the FDA, PIC/S, EMA, WHO require 1In situ Air Pattern Analysis (Smoke Studies or Air Flow Visualization) 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 3cleanroom testing practices indicate “Neutrally Buoyant Tracer Particles” for Air Flow Visualization. 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).

The Tracer Particles used by Microrite, Inc. are NOT SMOKE PARTICLES. When properly diffused, a Neutrally Buoyant cloud-like fog of Tracer Particles sized between 0.3M and 0.5M is released into the cleanroom environment. These sterile particles are comprised of USP Grade Materials Such as Triethylene Glycol, Monopropylene Glycol, Dipropylene Glycol and purified water. The cloud of Tracer Particles is oil and glycerin free, non-condensing, FDA GRAS approved and is non-toxic. For typical Air Flow Visualization Studies, this fog does not condense and pool up on cleanroom surfaces or cleanroom equipment.

The Tracer Particle Solution is vaporized at ~320˚C creating a sterile and hot vapor that exits from the cleanroom vaporizer into an expansion chamber, mixing with inlet air and traveling via a high temperature silicone tube to the Diffuser System. The Diffuser System/Manifold releases a cloud of very small Tracer Particles that cool when exiting the diffuser becoming Neutrally Buoyant when entering the air stream. Neutrally Buoyant Tracer Particles are not affected by gravity and will accurately follow the air currents and identify turbulence, dead spaces and eddy currents.