What type of area is a Segregated Compounding Area (SCA)?

A Segregated Compounding Area (SCA) is a designated space that is meant for compounding sterile preparations. It is classified as a specific type of controlled environment that allows for sterile compounding to occur outside of a traditional clean room but still maintains a level of cleanliness and control over environmental factors that can affect product sterility.

The classification of an SCA indicates that it meets certain conditions set forth by regulatory bodies, such as the United States Pharmacopeia (USP), specifically USP <797>, which outlines standards for compounding sterile preparations. While it is not a full clean room, it must still provide a controlled environment where compounding can be done safely and effectively, minimizing the risk of contamination.

Understanding the role of an SCA is important for the practice of sterile compounding, as it addresses how the area is designed to ensure that the compounded products remain sterile. The distinction of the SCA as a classified area conveys its importance in maintaining the integrity of compounded sterile products, ensuring compliance with standards that are crucial for patient safety.