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Cleanroom Classification – ISO 14644-1 & GMP Standards

2025-08-21

When planning a cleanroom, determining its classification is one of the most critical steps. Cleanroom classification defines the acceptable levels of airborne particles and ensures compliance with ISO 14644-1 and GMP (Good Manufacturing Practice) standards.

Proper classification guarantees product quality, process reliability, and regulatory compliance.

1. What Is Cleanroom Classification

A cleanroom classification defines the maximum allowable number of airborne particles per cubic meter at specific particle sizes.
Each classification level corresponds to a different degree of cleanliness required by various industries such as pharmaceuticals, biotechnology, microelectronics, and food processing.

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