What is the minimum air change per hour (ACPH) required in a buffer area?

The minimum air change per hour (ACPH) required in a buffer area is 30 ACPH. This standard is crucial for maintaining proper airflow and contamination control in sterile compounding environments. The buffer area is where sterile compounding takes place, and ensuring an adequate number of air changes helps to dilute and remove any potential contaminants from the air, thereby protecting the integrity of the compounded sterile preparations.

In this context, air changes refer to the number of times the entire air volume of the buffer area is replaced in one hour. A rate of 30 ACPH is recognized as sufficient to achieve a clean room environment appropriate for sterile compounding, in accordance with standards outlined by organizations such as USP (United States Pharmacopeia). This level of air exchange helps maintain the necessary environmental conditions, reducing risks of particulate and microbial contamination during the compounding process.