What is the volume needed for Active (Viable) Air Sampling according to USP 797?

The appropriate volume for Active (Viable) Air Sampling according to USP 797 is indeed between 400 Liters and 1000 Liters. This range is established to ensure the collection of a sufficient number of samples to accurately assess the microbiological quality of the compounding environment.

By collecting samples within this volume range, it increases the probability of capturing airborne microorganisms, thereby providing a representative assessment of potential contamination in sterile compounding environments. This is particularly critical in maintaining the integrity of the sterile products being prepared, as even low levels of viable particles can pose a risk to patient safety. Using volumes lower than this range may not yield reliable results, while exceeding it could lead to unnecessary resource utilization without corresponding benefits.

Ensuring that air sampling follows this volume standard aligns with the goals of USP 797 to minimize risks of contamination in sterile compounding.