Cleanroom Standards and Classifications
Cleanrooms are classified based on the number and size of particles permitted per volume of air. The most widely recognized classification standards are provided by the International Organization for Standardization (ISO) under the ISO 14644 series.
ISO 14644 Standards
The ISO 14644 standards outline the methodologies for testing and classifying clean rooms, including:
- ISO 14644-1 – Specifies the classification of air cleanliness by particle concentration.
- ISO 14644-2 – Covers specifications for testing and monitoring to ensure continued compliance with cleanliness standards.
- ISO 14644-3 – Outlines the test methods required for clean rooms, including tests for air volume, filter integrity, and airflow visualization.
- ISO 14644-4 – Provides guidelines for cleanroom design, construction, and startup procedures.
ISO 14644-1 Cleanroom Classifications
ISO cleanroom standards range from ISO 1 (the cleanest) to ISO 9 (less stringent). The classification is determined by the number of particles of a specific size (in micrometers, µm) that are allowed per cubic meter of air.
Applications Across Industries
- Pharmaceuticals – Cleanrooms are used to ensure that drug production is free from contaminants that could affect patient safety. The most common clean room classifications used are ISO 5 to ISO 8.
- Semiconductor Manufacturing – This industry requires extremely clean environments, often ISO 1 to ISO 4, to prevent defects in microchips and other sensitive components.
- Aerospace – In aerospace manufacturing, cleanrooms are used for the assembly of components that must be free from particulate contamination, such as satellite and spacecraft parts. Clean room classifications typically used are ISO 5 to ISO 8.
