Compounding Aseptic Containment Isolators (CACI)

Compounding Aseptic Containment Isolators (CACI) for Sterile Hazardous Drug Compounding

Compounding Aseptic Containment Isolators (CACI) are engineered to provide simultaneous protection for personnel, product, and the surrounding environment during sterile hazardous drug compounding. Operating under negative pressure with HEPA-filtered, unidirectional airflow, these systems maintain an ISO Class 5 work zone while containing aerosols, vapors, and particulates generated during pharmacy workflows.

Modern CACI platforms support compliance with USP <800> and USP <797> guidelines by combining leak-tight construction, pressure monitoring, and controlled transfer processes between the work chamber and pass-through or interchange areas. Integrated glove ports, sealed viewing windows, and ergonomic arm positions help minimize operator fatigue while maintaining a robust containment barrier.

At ARES Scientific, our CACI offerings include both dedicated negative-pressure hazardous drug isolators and flexible systems that can be configured for different compounding scenarios. For non-hazardous sterile applications that prioritize product protection without hazardous containment, we also offer a full range of Biological Safety Cabinets to complement your pharmacy cleanroom design.

Key Selection Factors for Compounding Aseptic Containment Isolators

Pressure Regime and Containment: Confirm that the isolator maintains the appropriate negative pressure setpoint relative to the room to protect staff from hazardous drug exposure during routine and worst-case operations.
Air Quality and Filtration: Verify that the work zone and transfer chamber meet ISO Class 5 cleanliness criteria with validated HEPA filtration on both supply and exhaust air streams.
Exhaust Configuration and Ducting: Determine whether the CACI will be fully ducted to the facility exhaust, partially recirculating, or connected to dedicated filtration modules to accommodate volatile or highly toxic compounds.
Chamber Design and Ergonomics: Evaluate glove port spacing, viewing window angle, reach distances, internal lighting, and pass-through design to support long compounding sessions without compromising technique.
Cleaning, Decontamination, and Materials: Select interior finishes and seals compatible with your approved disinfectants and sporicidal agents, and confirm that all surfaces are accessible for routine cleaning and terminal decontamination.
Compliance, Monitoring, and Documentation: Look for integrated pressure and airflow monitoring, alarm capabilities, and certification support to satisfy USP <797>/<800>, CETA, and internal quality or regulatory audit requirements.

Frequently Asked Questions About Compounding Aseptic Containment Isolators

What is the difference between a CACI and a CAI?

A Compounding Aseptic Containment Isolator (CACI) is designed for hazardous drug compounding and operates under negative pressure to protect personnel and the environment while maintaining an ISO Class 5 sterile work zone. A Compounding Aseptic Isolator (CAI) is typically used for non-hazardous sterile preparations and often operates under positive pressure to prioritize product protection. Many pharmacy facilities use CACIs for hazardous drugs and CAIs or biological safety cabinets for non-hazardous sterile compounding.

When is a CACI required instead of a standard biological safety cabinet?

A CACI is recommended when sterile hazardous drugs must be compounded in a fully enclosed, glovebox-style environment with a hard physical barrier between personnel and the work zone. While certain biological safety cabinets can support hazardous drug handling, CACIs provide an additional level of containment by combining negative pressure, sealed glove ports, and controlled transfer chambers, which can be advantageous for high-risk or high-volume chemo compounding programs.

What standards should a CACI help me comply with?

Your CACI should support compliance with USP <800> for hazardous drug handling and USP <797> for sterile compounding, as well as relevant guidance from CETA, local Board of Pharmacy regulations, and internal health system policies. Look for clear manufacturer documentation on performance testing, pressure setpoints, airflow patterns, and filter integrity verification.

How often should a CACI be certified and tested?

Most pharmacy facilities require certification at installation, after relocation or major maintenance, and at least annually thereafter. Certification typically includes verification of pressure differentials, airflow patterns, particle counts, and HEPA filter integrity, along with checks of alarms, gauges, and other monitoring devices to ensure the system is performing as designed.

Can a CACI replace a full cleanroom?

A CACI can significantly reduce the contamination risk and may allow more flexibility in room design, but it does not automatically eliminate all cleanroom requirements. The surrounding room must still meet the applicable engineering, pressure, and cleanliness criteria defined by USP <797> and USP <800>. Many facilities use CACIs within a buffer room and ante-room layout to achieve both regulatory compliance and robust environmental control.