For ISO Class 7, what is the action level for Colony Forming Units?

In an ISO Class 7 cleanroom, the action level for Colony Forming Units (CFUs) is set at 10 CFUs for a viable count in an area measurement. This standard is established to maintain an environment conducive to sterile compounding, ensuring adequate control over particulate and microbial contamination.

An action level indicates a threshold at which corrective actions must be taken to maintain the integrity of the cleanroom environment. The reasoning behind setting the action level at 10 CFUs lies in balancing the risks of contamination with operational practicalities. Levels above this can indicate that the environment is not being adequately controlled, necessitating further investigation and remediation.

Maintaining environments classified according to ISO standards is critical, especially in settings where sterile preparations are being compounded, to safeguard patient safety and ensure compliance with regulations.