ISO 14644-1 is the international standard that classifies the cleanliness of air in cleanrooms and controlled environments by the maximum allowed concentration of airborne particles. It replaced the older US Federal Standard 209E (Class 100, 1000, etc.).
ISO 14644-1 defines classes from ISO 1 (cleanest) to ISO 9. In practice, most pharmaceutical, biotech and electronics work uses ISO Class 5 to ISO Class 8. ISO Class 5 allows a maximum of 3,520 particles ≥0.5µm per cubic metre — the level provided by a laminar flow hood or a Grade A zone.
The required class depends on your process. Sterile compounding and aseptic filling typically need ISO 5 at the point of work; surrounding areas may be ISO 7 or 8. Our team helps you specify the right class for each zone. See our modular cleanrooms and laminar flow hoods.
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