How does risk assessment contribute to sterile compounding?

Risk assessment plays a crucial role in sterile compounding by identifying potential hazards and mitigating risks, which directly supports the safety and effectiveness of compounded sterile products. In a sterile compounding environment, there are various risks, including contamination, equipment failure, and human error. Through risk assessment, compounding personnel can systematically identify these hazards, evaluate their likelihood and potential impact, and implement strategies to minimize or eliminate them.

This proactive approach is essential in ensuring compliance with USP 797 standards, which demand a high level of cleanliness and sterility in compounding practices. By recognizing and addressing risks, facilities can enhance the quality of their compounded products, protect patients from harm, and ensure that product efficacy is maintained. Risk assessment thus serves as a foundational element in promoting safety and quality in sterile compounding, making it a critical component of the compounding process.