Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to which ISO class?

The correct choice is based on the standards set forth by USP 797, which governs sterile compounding practices and ensures that compounded sterile preparations (CSPs) are made in environments that minimize contamination risk. According to these regulations, sterile ingredients, components, devices, and mixtures must be prepared in environments that are at least ISO Class 5 or better.

ISO Class 5 air quality sets a standard of no more than 3,520 particles per cubic meter for particles greater than 0.5 microns in size. This stringent limit helps to ensure that the risk of contamination is significantly reduced, which is crucial for maintaining the sterility of compounded preparations. Environments with air quality that is worse than ISO Class 5 allow for a higher concentration of airborne contaminants, which increases the likelihood of introducing microbial or particulate contamination into sterile products.

In contrast, ISO Class 3, ISO Class 7, and ISO Class 9 are all levels that have higher allowable particle counts than ISO Class 5, meaning that environments classified at those levels would not provide the necessary sterility assurance required by USP 797. Thus, preparations should not be exposed to air quality inferior to ISO Class 5 to maintain the integrity and safety of sterile products.