ISO 14644

What ISO 14644 Is

ISO 14644 is a series of international standards that define how to classify the cleanliness of cleanrooms and controlled environments, based on the concentration of airborne particles per cubic metre.

Cleanliness Classification (ISO Class)

The standard ranges from ISO Class 1 (cleanest) to ISO Class 9, with Grade A aseptic filling areas typically required to meet ISO Class 5 or better.

Testing and Certification Methods

Certifying a cleanroom involves particle counting, airflow velocity measurement, air change rates, and differential pressure testing, following the procedures set out in ISO 14644-2 and 14644-3.

Relationship to GMP

Although ISO 14644 is a technical standard, pharmaceutical regulators such as PIC/S and the FDA reference its cleanliness classes when assessing GMP cleanroom grades.