What ISO class air quality environment is necessary for sterile compounding?

In sterile compounding, the environment must maintain a high level of cleanliness to prevent contamination of sterile products. An ISO class 5 environment is mandated because it allows for a maximum of 3,520 particles per cubic meter that are larger than 0.5 microns in size. This level of air quality ensures that airborne contaminants are kept to a minimum, which is crucial when preparing sterile medications.

ISO class 5 environments are specifically designed to provide the necessary level of protection against particulate and microbial contamination during compounding procedures, particularly in laminar flow hoods or compounding aseptic isolators. These areas are critical for hand hygiene and control of environmental factors, thus contributing to patient safety and the overall efficacy of the sterile products.

The other classes, while still maintaining controlled environments, do not meet the stringent requirements necessary for ensuring sterility during compounding. A higher ISO class number represents a less clean environment, which would not be suitable for sterile preparations.