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Welcome>Cleanroom Classification

ISO classification is based on the number of airborne particles present in the cleanroom environment, measured using specialized particle counters during cleanroom certification.


ISO 14644 cleanroom classification table_

Different particle sizes are analyzed, including: 0,1 µm; 0,3 µm; 0,5 µm; 1 µm; 5 µm. The results are compared against the maximum limits established by ISO 14644-1.

 

Most commonly used ISO classes

Although ISO 14644 defines nine cleanroom classes, the most commonly used in industrial applications are:

  • ISO 5 → critical processes (pharmaceutical manufacturing, aseptic filling)
  • ISO 7 → controlled production areas
  • ISO 8 → support and preparation areas

 

Applications by cleanliness level

  • ISO 1–3 → microelectronics, nanotechnology
  • ISO 4–5 → sterile processes, pharmaceutical industry
  • ISO 6–7 → medical devices, biotechnology
  • ISO 8–9 → controlled industrial production
Cleanroom Classification

Importance of ISO classification in cleanroom design

ISO classification directly defines:

  • HVAC system requirements
  • Air filtration systems
  • Air changes per hour (ACH)
  • Pressure control strategy
  • Airflow type

For this reason, ISO classification is one of the first parameters established during the cleanroom design process.

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IQM

Microelectronics

Saint-Gobain Sekurit

Automotive

Roche

Biopharmaceutical

Graphenea

Microelectronics

Qiagen

Biotechnology

Grupo MERCK

Biopharmaceutical

H&T Presspart

Medical Devices

Mabxience

Biotechnology

Merck Serono

Biopharmaceutical

FAE

Automotive

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