What is considered a "critical site" in the context of compounding?

A "critical site" is defined as any location or component that exposes a compound to potential contamination and therefore must be handled with strict adherence to aseptic techniques. In the context of compounding, this typically refers to areas within a cleanroom environment where sterile products are manipulated.

These critical sites include the surfaces of sterile equipment and devices, the connections on sterile containers, and areas where sterile components are directly interfaced with non-sterile substances. By maintaining stringent controls and practices in these locations, the risk of introducing pathogens or particulates into compounded sterile preparations is minimized. This is vital for ensuring patient safety and adherence to regulatory standards outlined in USP 797.

Other options described do not fit the definition of a critical site within sterile compounding. For example, developing marketing strategies involves no risk of contamination related to the compounding process, and while the location where compounded preparations are created may be important, it's the specific areas and surfaces during the preparation that are highlighted as critical. Lastly, storing compounded medications does not expose them to risks associated with contamination during the compounding process itself.