Iso 146443pdf 2021 -

Overview

ISO 14644-3:2021 specifies the test methods for cleanrooms and associated controlled environments. The standard provides a framework for evaluating the performance of cleanrooms and controlled environments in terms of their ability to control airborne particulate contamination.

4.5 Airflow Visualization (Smoke Studies)

• Purpose: Demonstrate unidirectional flow direction, turbulence, or containment.
• Tools: Smoke generators (DI water, glycol, or mineral oil) + video recording.
• New in 2019: Quantitative turbulence intensity measurement.

1. Recommended Tests (The "Must-Haves")

These tests are considered essential for the basic characterization of a cleanroom. If you are doing a classification, you are almost certainly performing these: iso 146443pdf 2021

• Airborne Particle Counting: The most critical test. This verifies the concentration of particles at defined locations to ensure the room meets its target ISO Class (e.g., ISO 7 or ISO 8).
• Airflow Volume and Velocity: This verifies that the air handling system is providing sufficient air changes per hour (ACH) or unidirectional flow velocity to dilute or flush out contaminants.
• Pressure Difference (Differential Pressure): This ensures the cleanroom is positively (or negatively, for containment) pressurized relative to adjacent areas to prevent unfiltered air from leaking in.

1. Airborne Particle Count Test (Annex A)

• Purpose: Verifies that the cleanroom meets its ISO class (e.g., ISO 5, ISO 7).
• Key change in 2019: Alignment with ISO 14644-1:2015’s new particle size thresholds and sampling point formulas.
• Instruments: Discrete-particle counters (light scattering or condensation nucleus counters).