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According to ISO 14644, which provides guidelines for cleanrooms and associated controlled environments, the particle count test is an essential part of evaluating the cleanliness of pharmaceutical environments. The standard specifies limits for particle counts based on different particle size ranges.

For non-viable particle count testing in pharmaceuticals, ISO 14644-1 establishes limits for two particle size ranges: 0.5 micrometers and 5.0 micrometers. These limits are expressed as maximum allowable concentrations per cubic meter of air.

The ISO 14644-1 standard specifies the following maximum allowable concentrations for non-viable particles in cleanrooms:

Particle Size Range

ISO Class 5

ISO Class 7

ISO Class 8

0.5 micrometers




5.0 micrometers




These limits represent the maximum number of particles allowed in each size range for different cleanroom classifications (ISO Class 5, ISO Class 7, and ISO Class 8).

It’s important to note that these values are subject to specific requirements and may vary depending on the specific application and regulatory standards of the pharmaceutical industry. Therefore, it is crucial to consult the relevant regulatory guidelines and specific requirements applicable to your region and facility.

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