What should the air quality be in an ante-area used for sterile compounding?

In the context of sterile compounding, the air quality in the ante-area is crucial for maintaining a controlled environment that minimizes the risk of contamination. An ante-area is the space where compounded sterile preparations (CSPs) are prepared before they enter the actual cleanroom or buffer area.

ISO Class 8 or better is the standard specified for ante-areas in sterile compounding settings. This classification indicates acceptable levels of airborne particulate contamination, ensuring a safer environment for both staff and the preparations being made. The ISO Class 8 standard allows for a higher number of allowable particles per cubic meter compared to more stringent classes, which is appropriate since the ante-area typically does not directly involve the sterile preparation process but serves as a transition area to the more controlled atmosphere of the cleanroom.

Maintaining this air quality standard in the ante-area supports contamination control by reducing the amount of particulates in the air, which can be a source of microbial contamination. Overall, having an ante-area designated as ISO Class 8 provides a balance between operational efficiency and necessary cleanliness, aligning with the goals of USP 797 to ensure patient safety in the final compounded product.