How are "critical sites" defined in sterile compounding?

In sterile compounding, "critical sites" are identified as areas that have a high risk of contamination due to their proximity to exposed sterile products. These sites include locations where sterile materials, such as needles or syringes, are either inserted or withdrawn. Examples of critical sites are the tips of needles, the ports of IV bags, and any other access points that come into contact with sterile components. Protecting these sites from contamination is essential to maintain the sterility of compounded products and to ensure patient safety.

Understanding the significance of critical sites is vital in adhering to the protocols outlined in USP 797. These guidelines aim to minimize the risk of infections and ensure that any compounded sterile preparations are free from harmful microbial contamination. Proper techniques such as using aseptic manipulation and adhering to strict gowning and cleaning procedures are employed to safeguard these critical areas during compounding processes.