Are Class 2 BSC and CAIC both appropriate ventilated engineering controls for sterile HD compounding?

• A. Only CAIC is appropriate
• B. Only Class 2 BSC is appropriate
• C. Both Class 2 BSC and CAIC are appropriate
• D. Neither is appropriate

Answer: (C)

In sterile hazardous drug compounding, the devices used to contain aerosols and protect both the worker and the product are ventilated engineering controls. Class II biological safety cabinets and containment aseptic isolators are designed to meet that need by controlling airflow and using HEPA filtration, but they do so in different ways.

A Class II BSC provides a work surface inside a certified cabinet with laminar inward airflow and HEPA-filtered air. This setup protects the product from contamination and protects the worker from exposure, as the airflow and filtration trap and remove hazardous drug particles. It’s appropriate for direct aseptic manipulations and is a common choice when you have the room ventilation to support proper cabinet operation and where routine decontamination and certification are feasible. When used for hazardous drugs, the cabinet’s exhaust path and certification must ensure containment and compliance with regulatory requirements.

A containment aseptic isolator (CAIC) is a closed, sealed environment that isolates the work from room air. Manipulations occur through integrated gloves, and the internal air is continuously controlled and filtered, providing a high level of containment. This option is especially advantageous when maximum isolation is desired or when room ventilation does not provide adequate containment. Like the BSC, the isolator must be validated for HD use and properly maintained.

Because both options provide ventilated containment suitable for sterile HD compounding, they are both appropriate when used correctly, validated, and integrated into the facility’s overall containment strategy.