What is the primary classification of the inside perimeter used in the segregated compounding area?

The primary classification of the inside perimeter used in the segregated compounding area is typically ISO Class 5. This classification is significant because ISO Class 5 environments are designed to provide adequate air quality to limit the risk of contamination during the preparation of sterile products. Specifically, ISO Class 5 air cleanliness standards allow for a maximum of 3,520 particles per cubic meter at a size of 0.5 microns or larger.

In the context of a segregated compounding area, which is intended for the preparation of low-risk level compounded sterile preparations, maintaining an ISO Class 5 environment is crucial to ensure that the sterility of the compounded products is not compromised. The air cleanliness standards associated with ISO Class 5 help to minimize the presence of airborne particles, thus reducing the potential for microbial contamination.

In comparison, ISO Class 6, ISO Class 7, and unclassified environments do not meet the stringent requirements needed for sterile compounding as effectively as ISO Class 5. Thus, for facilities that prepare compounded sterile preparations, ISO Class 5 is the standard classification that must be maintained within the inside perimeter of the segregated compounding area to ensure patient safety and product integrity.