ISO 14644 Cleanroom Classification: Particle Count Limits, Testing Methods & Lab Procedure

ISO 14644 is the international standard to define how clean a cleanroom must be. Published by the International Organization for Standardization, it is done by measuring the concentration of airborne particles. The ISO 14644-1 standard is applicable to several types of industries including healthcare, pharmaceuticals, food production, medical device and aerospace manufacturing, etc.  ISO 14644-1 classifies cleanrooms on the basis of number and size of particles per cubic meter of air.

ISO 14644 is an international standard that defines classes of air cleanliness for cleanrooms and controlled environments relative  to the number, or concentration, of particles in air volume.

Testing Methods For ISO 14644 Classification

1. Airborne Particle Concentration

In this method a calibrated aerosol particle counter is used to measure particle concentrations at given sampling locations. This type of testing is carried out in ‘as-built’ , ‘at-rest’ or ‘operational’ states.

2. HEPA/ULPA Filter Leakage Test

In this type of test, an aerosol challenge (for example DOP or PAO) is usually introduced upstream of the filter, while the particle counter monitors and scans the downstream side, joints and seal of leaks.

3. Airflow Volume & velocity Test

In this type of test, airflow velocity is measured using a vane anemometer. At times, the total airflow volume is also measured in non-directional rooms using a hood. This is done to ensure sufficient air changes.

4. Pressure Differential Test

A manometer is used to measure the pressure difference between the cleanroom and adjacent spaces. This test is performed to confirm that the room has the right positive pressure to prevent contamination influx.

5. Airflow Visualization Or Smoke Study

In this testing method, airflow patterns are visualized with smoke to check that laminar flow is achieved. It is also done to ensure that there are no stagnant spots or turbulence that could concentrate particles.

ISO 14644-1 Air Classifications: Particle Count Limits

Frequently Asked Questions

1. What is the primary change to ISO 1466-2?
The primary change to the standard is related to the emphasis of using a risk assessment approach for process monitoring.

2. What are the key factors to keep in mind when working on a new cleanroom facility?
Airflow system, select non-porous materials and maintain pressure differential.

3. Best & most reliable cleanroom manufacturer in Saudi?
With over 15 years of experience, Zeibaq is one of the trusted affordable and reliable cleanroom manufacturers.