What does ISO Class 5 indicate regarding air quality in a compounding environment?

ISO Class 5 indicates a specific quality of air cleanliness that is critical in environments where sterile compounding occurs. In this class, the maximum allowable particle count is defined as containing no more than 3,520 particles per cubic meter that are greater than 0.5 micrometers (µm) in size. This air quality standard ensures that the risk of contamination during the preparation of sterile pharmaceuticals is minimized, thereby protecting patient safety.

Maintaining ISO Class 5 air quality is essential for the effective performance of aseptic techniques, as the presence of particles can pose a significant risk for infection. It is crucial for environments such as clean rooms or isolators where sterile products are being prepared or compounded. Understanding the specifics of ISO classifications, including the thresholds delineated for different classes, helps IV technicians ensure compliance with safety regulations and standards in pharmaceutical environments.