What is the required air change per hour (APCH) in an ISO Class 7 area?

In an ISO Class 7 area, the required air change rate is 30 air changes per hour (APCH). This standard is established to maintain the necessary cleanliness and control particulate contamination within environments where sterile compounding occurs. The high turnover of air helps to dilute and remove contaminants that could compromise the sterility of compounded preparations. This requirement is critical to ensure the safety and efficacy of sterile products.

Other options do not meet the established standards for ISO Class 7 areas and do not provide adequate control over airborne particulate levels required to maintain the integrity of sterile compounding environments.