How many air changes per hour are required in the ante area, assuming it is classified as ISO class 8?

The requirement for air changes per hour in the ante area classified as ISO class 8 is set at a minimum of 15 air changes. This standard is established to maintain the appropriate environmental control necessary for compounding sterile preparations.

ISO class 8 requires a certain level of particulate contamination control, and having at least 15 air changes per hour helps to dilute and remove airborne particles that could compromise sterility during the compounding process. It ensures that any microorganisms or particulates are sufficiently reduced in concentration in the air, contributing to a safer working environment for both the staff and the preparations being made.

This regulation aims to ensure a consistent flow of clean air, which is critical for maintaining cleanliness and preventing contamination in areas where sterile compounding occurs. The higher number of air changes helps in achieving low particle counts, adhering to the standards necessary for safe and effective sterile compounding practices.