What is meant by "ISO class" in the context of cleanrooms?

The term "ISO class" in the context of cleanrooms refers specifically to the classification of air cleanliness levels based on particle count. This classification system is based on ISO 14644-1 standards, which determine the maximum allowable number of particles of specified sizes per cubic meter of air. Cleanrooms are categorized into different ISO classes ranging from ISO Class 1, which has the strictest cleanliness requirements with very few particles, to ISO Class 9, which allows a higher concentration of particles.

In sterile compounding, maintaining the appropriate ISO class is crucial because it directly impacts the sterility of pharmaceutical products. A lower ISO class indicates better air quality and fewer contaminants, which is essential to ensure that compounded sterile preparations do not become contaminated during the compounding process. Higher ISO classes may not provide the necessary environment for sterile operations, leading to an increased risk of infections or complications in patients receiving these products.

While the other choices touch on relevant aspects of cleanrooms, they do not accurately define ISO classes. For instance, the number of sterile compounds produced in a cleanroom and the organizational structure of cleanroom personnel do not directly relate to the cleanliness and air quality that ISO classes measure. The age of the facility also does not determine its ISO classification