What is the minimum number of air changes per hour required in the buffer area of an SEC?

In sterile compounding environments, particularly in the buffer area of a sterile compounding environment (SEC), maintaining appropriate air quality is essential to prevent contamination. The minimum requirement of air changes per hour is set to ensure that any potential contaminants are effectively diluted and removed from the space.

The regulation specifies that the buffer area must have a minimum of 30 air changes per hour. This high rate of air exchange helps to maintain the integrity of the sterile environment by reducing airborne particles and maintaining a controlled atmosphere that is conducive to safe compounding practices.

Higher air change rates are crucial in these areas because they directly correlate to the reduction of viable contaminants, therefore providing a safer environment for both the compounding personnel and the patients receiving the sterile preparations. This standard highlights the importance of rigorous cleanliness and contamination control in the sterile compounding process.