How often should environmental monitoring be performed in compounding areas as per USP 797?

Environmental monitoring in compounding areas, as per USP 797, should be performed on a regular schedule determined by the quality assurance program. This approach allows the facility to tailor the monitoring frequency based on specific risks associated with their compounding activities, workflow patterns, and overall sterile compounding practices. By utilizing a quality assurance program, facilities can ensure that monitoring is comprehensive and responsive to changes in the environment, processes, or staff, which is critical for maintaining sterility and patient safety.

Regularly scheduled monitoring helps identify potential contamination sources or trends over time, facilitating timely interventions to maintain compliance with established standards. The adaptability of this method allows for increased scrutiny during high-volume periods or following significant changes in the compounding process while still ensuring oversight during quieter times.

Establishing a specific frequency based solely on rigid parameters or only in response to training or compliance needs would not adequately address the dynamic nature of compounding environments, emphasizing the importance of a tailored approach in maintaining sterile conditions.