In which ISO class does a LAFH operate?

A LAFH, or laminar airflow hood, operates within ISO class 5. This classification indicates a controlled environment that ensures a low level of airborne particulates, which is critical for maintaining the sterility of compounded sterile preparations.

ISO class 5 must have a maximum allowable particulate count of 3,520 particles per cubic meter of air that are 0.5 micrometers or larger. This level of air cleanliness is essential for any area where sterile compounding is performed, as it minimizes the risk of contamination by airborne particles, ensuring patient safety and adherence to regulatory standards.

In comparison, ISO classes 4 and 6 have different particulate count limits, meaning they do not provide the same level of cleanliness as ISO class 5, and class 7 allows even more particles than class 6. Therefore, for the specific needs of a LAFH, ISO class 5 standards are necessary to ensure a contamination-free environment for the preparation of sterile products.