For low and medium risk CSPs, what is the recommended frequency of Active (Viable) Air Sampling?

The recommended frequency of Active (Viable) Air Sampling for low and medium risk Compounded Sterile Preparations (CSPs) being every 6 months is rooted in maintaining a critical balance between product safety and operational efficiency. This interval is established by guidelines to ensure that the sterile compounding environment is regularly monitored for microbial contamination.

Conducting air sampling every 6 months helps to identify any microbial growth or changes in the facility's cleanroom environment that could compromise sterility, ensuring that any potential issues can be addressed promptly. By adhering to this schedule, facilities can demonstrate compliance with regulatory standards and maintain a high level of quality control.

More frequent sampling might lead to unnecessary use of resources, while less frequent sampling could increase the risk of contamination going unnoticed for longer periods, affecting patient safety. Thus, the 6-month interval is a balanced approach that aligns with best practices in sterile compounding.