ISO Standards that apply to cleanrooms include:

  1. ISO 14644-1, which defines the classification of airborne particulate cleanliness based purely on the concentration of airborne particles in the air of a clean zone.

  2. ISO 14644-2 Which sets down periodic testing requirements to ensure that a clean zone or cleanroom continues to follow its ISO 14644-1 classification

Some Common Factors - Cleanroom Design

Since cleanrooms have a significant impact on quality assurance and product integrity, various parameters need to be taken into consideration while designing them.

Along with the type of product being manufactured, cleanroom design needs to account for other factors such as temperature, relative humidity, air flow and air changes per hour, which is why the EMS or environmental monitoring system is considered the most important instrumentation within clean zones.

Along with HVAC systems and alarm monitoring systems, Magnehelic gauges and other differential pressure sensors are used to help keep these controlled environments sterile. These devices can help measure and control airflow, cleanliness of HEPA filters, proper static pressure between cleanrooms and adjoining spaces, and more.

Energy efficiency is another aspect of cleanroom design that companies need to consider. Properly calibrated pressure sensors help HVAC control systems maintain accurate positive pressure, with very low levels of pressure. This allows for conditioned air to be saved within the clean zone and fans to run less, thus saving energy.

Link to ISO 14644-1 https://www.iso.org/standard/53394.html

Link to ISO 14644-2  https://www.iso.org/standard/53393.html