What is the classification of the air in a Compounding Aseptic Isolator (CAI)?

The classification of air in a Compounding Aseptic Isolator (CAI) is ISO 5 or better. This classification indicates that the air within the isolator must have a maximum allowable particle count of 3,520 particles per cubic meter of air that are 0.5 micrometers in size or larger.

ISO 5 air quality is essential for sterile compounding because it minimizes the risk of contamination from airborne particles, which is crucial when preparing sterile medications. The CAI is designed to provide a controlled environment where aseptic techniques can be employed effectively, and maintaining ISO 5 conditions supports the integrity of compounded sterile preparations.

In sterile compounding environments, such as those found in pharmacies or healthcare settings, compliance with the ISO classifications is critical for patient safety and ensuring that compounded preparations meet the necessary sterility standards.