How frequently should particle counts be conducted in hazardous compounding?

In the context of hazardous compounding, particle counts are critical for ensuring the sterility and safety of compounded products. These counts are typically performed to evaluate the cleanliness of the compounding environment, specifically in cleanrooms or controlled environments.

The correct frequency for conducting particle counts in hazardous compounding is every six months. This interval aligns with the guidelines set by regulatory bodies such as the United States Pharmacopeia (USP), which stipulate that air and surface sampling needs to be performed at least every six months to maintain an acceptable level of cleanliness and to ensure compliance with standards.

Performing particle counts semi-annually allows compounding facilities to monitor the effectiveness of their cleaning procedures and to make necessary adjustments to their processes. This frequency is seen as a balance between having a rigorous quality assurance process without overwhelming resources.

While daily and monthly frequencies may appear to provide more thorough monitoring, they are generally not required by current standards and can lead to unnecessary resource expenditures. Annually is too infrequent to ensure the required level of environmental control, meaning that any contamination issues could go unnoticed for too long, risking the safety of compounded medications.

This understanding of particle counting frequency is vital for pharmacists and compounding facilities to ensure the safety and efficacy of hazardous drug preparations, adhering