ISO 14644 And Cleanroom Standards, Classification, Test Methods And Compliance Requirements

The semiconductor industry together with biomedical and food processing require Cleanrooms to guarantee product quality. Cleanroom management follows the international requirements described in the ISO 14644 standard that details air cleanliness classes and test procedures and compliance protocols.  

1. What is ISO 14644?

ISO 14644 is a Cleanroom specification developed by the International Organization for Standardization that centers on classifying cleanrooms based on the concentration of airborne particulate matter and specifies how clean environments should be tested and maintained.  

2. Cleanroom Air Cleanliness Classes

ISO 14644-1 establishes the Cleanroom classification system ISO 1 through ISO 9 which defines higher cleanliness through lower numerical values. The standard ISO Classes 1-3 serve semiconductor manufacturing while pharmaceuticals and laboratories need ISO Classes 4-5 and all indoor environments with food or medical purposes utilize ISO Classes 6-8. The limits for particulates in Cleanroom air follow specific criteria under ISO standards where ISO Class 5 permits no more than 3,520 particles for ≥0.5μm yet ISO Class 8 supports up to 35,200,000 particulates.  

 3. Clean Room testing and validation

The standards provided by ISO 14644-2 determine what is needed for periodic monitoring of Cleanrooms through the following requirements:  

• Airborne particulate matter testing: Testing air particulate matter using airborne measurement devices falls under this category.  

• Airflow pattern test: A smoke test functions to check whether the air flow maintains even distribution throughout the area of examination.  

• Air change count and air velocity measurements: Air change count and air velocity measurements: Ensure adequate supply of clean air.  

• Differential Pressure Control: A necessary requirement is to maintain positive pressure in high cleanliness areas since it stops outside contaminants from invading these spaces.

4. How to ensure Cleanroom compliance with ISO 14644?

• Design phase: The selection of appropriate filtration grade with HEPA/ULPA filters and proper airflow design takes place during the design phase.

• Construction phase: Construction activities should use dust-reducing materials together with proper sealing methods to minimize pollution emission points.

• Operation phase: The operation stage requires continuous monitoring of air quality and equipment maintenance with entry controls for people and materials to the process.