What are the airflow and pressure requirements of a Containment Segregated Compounding Area (C-SCA)?

A Containment Segregated Compounding Area (C-SCA) is designed to ensure the safety of sterile compounding, particularly when handling hazardous drugs. The correct answer indicates that the airflow requirement should be 12 Air Changes Per Hour (ACPH) with a negative pressure environment.

The reason for maintaining a negative pressure in a C-SCA is to prevent any hazardous drugs from escaping the compounding area into surrounding areas, thereby protecting personnel, the environment, and other products or drugs that may be present nearby. This negative pressure ensures that any airborne contaminants or hazardous drug particles are contained within the C-SCA, minimizing the risk of exposure.

The airflow rate of 12 ACPH is typically established to ensure that there is adequate dilution of air and removal of any potential contaminants, ensuring a safe environment for compounding. Consistency in these standards is crucial for compliance with regulations and guidance provided by entities such as the United States Pharmacopeia (USP) and the Centers for Disease Control and Prevention (CDC).

Other options suggesting positive pressure, neutral pressure, or different airflow rates do not align with the established safety protocols for a C-SCA, demonstrating the importance of upholding the correct environmental controls to safeguard compounding practices.