Which ISO class is typically required for areas where sterile compounding occurs?

ISO Class 5 is the correct classification for areas where sterile compounding occurs due to its specific limits on airborne particulate contamination. In a controlled environment, such as a cleanroom, ISO Class 5 air cleanliness allows for no more than 3,520 particles per cubic meter for particles 0.5 microns or larger. This stringent standard ensures that the air is sufficiently clean to prevent contamination of sterile products during the compounding process.

In sterile compounding, maintaining an ISO Class 5 environment is critical because even a small number of contaminants can lead to serious health risks for patients, especially those with compromised immune systems. This classification is typically achieved through the use of laminar airflow hoods or isolators that provide a sterile working environment, limiting exposure to airborne contaminants.

While ISO Class 7 and ISO Class 8 areas have more lenient particle limits, they are generally used for less critical processes and do not provide the level of cleanliness required for the final preparation of sterile products. ISO Class 10 is not a standard classification used in sterile compounding environments. Therefore, the requirements of ISO Class 5 ensure that the highest level of sterility is maintained, protecting patient safety during compounding activities.