What is the minimum requirement for a primary engineering control device when compounding sterile products?

The minimum requirement for a primary engineering control device when compounding sterile products is ISO Class 5 air quality. This classification designates an area with a maximum of 3,520 particles per cubic meter, which is essential for maintaining the sterility of compounded products. ISO Class 5 environments ensure that airborne particulate matter is kept at a very low level, significantly reducing the risk of contamination during the compounding process. This is critical, as unsterile products can lead to severe patient safety issues, such as infections or other complications.

In sterile compounding, the primary engineering control device, such as a laminar airflow hood or a cleanroom, must provide this level of air quality to safeguard the sterility of the preparations being made. Higher ISO classifications, like ISO Class 7 or 8, allow for more particles in the air, which would not meet the necessary safety standards for sterile compounding. Therefore, ISO Class 5 is the benchmark that ensures compounded sterile products maintain their integrity and safety for patient use.