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What is Air Class 2?

Published in Cleanroom Standards 2 mins read

Air Class 2, in the context of cleanroom standards, refers to an exceptionally clean air environment. More specifically, it's a classification defined by ISO 14644-1, a widely recognized international standard for cleanrooms and controlled environments.

Here's a breakdown:

  • ISO 14644-1: This standard classifies air cleanliness based on the number of particles of a specified size allowed per cubic meter of air.

  • Cleanliness Level: ISO Class 2 is an extremely stringent cleanliness level. It's much cleaner than typical operating room environments.

  • Particle Limits: The key defining characteristic is the allowable particle concentration:

    • A cleanroom classified as ISO Class 2 must have a maximum of 100 particles of size ≥0.1 µm per cubic meter.
    • It also permits a maximum of 24 particles of size ≥0.2 µm per cubic meter.
    • Further, it allows a maximum of 10 particles of size ≥0.3 µm per cubic meter.
    • Finally, it permits a maximum of 4 particles of size ≥0.5 µm per cubic meter.

  • Applications: Cleanrooms with ISO Class 2 air are used in applications requiring the highest levels of contamination control. Examples include:

    • Manufacturing of semiconductors and microelectronics where even a single particle can cause defects.
    • Pharmaceutical manufacturing, particularly for sterile injectable drugs.
    • Nanotechnology research and development.
    • Certain types of medical device manufacturing.
    • Advanced materials research.

  • Achieving ISO Class 2: Achieving and maintaining this level of cleanliness requires sophisticated air filtration systems (typically HEPA or ULPA filters), stringent cleaning protocols, personnel gowning procedures, and airlocks to minimize particle introduction.

  • Implications: Maintaining an ISO Class 2 environment is costly and requires significant investment in infrastructure and operational practices.

In summary, Air Class 2 (as defined by ISO 14644-1) represents an extremely clean environment characterized by very low allowable particle counts, crucial for sensitive manufacturing and research processes.

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