What is the focus of risk assessment in sterile compounding?

In the context of sterile compounding, the primary focus of risk assessment is to identify potential hazards and implement controls to ensure the safety and quality of compounded sterile preparations. This process involves systematically evaluating every step of the compounding process to recognize factors that could compromise sterility or introduce contamination.

Identifying potential hazards is crucial because it allows compounding personnel to understand where risks exist, whether they are environmental (like air quality), procedural (like compounding techniques), or related to equipment (like sterilization methods). Once these hazards are identified, appropriate controls can be established, such as implementing standard operating procedures, utilizing proper personal protective equipment, or enhancing facility designs.

This focus on risk assessment aligns with the overarching goals of USP 797, which emphasizes the importance of maintaining safety and quality to protect patients who receive sterile compounded medications. By addressing potential risks proactively, the likelihood of contamination and adverse patient outcomes is significantly reduced, thereby enhancing the overall effectiveness of the compounding process.