Restricted Access Barrier Systems

A Restricted Access Barrier System, or RABS, is an enclosure that provides HEPA-filtered ISO Class 5 unidirectional airflow for sterile compounding. Materials enter and exit through defined transfer openings, while glove ports provide physical separation between personnel and the compounding work area. Review NuAire's RABS product family overview for model options and workflow configurations.

A Compounding Aseptic Isolator (CAI) is used for sterile, non-hazardous compounded sterile preparations. A Compounding Aseptic Containment Isolator (CACI) is used for sterile hazardous drug compounding and is designed to support both aseptic conditions and containment of hazardous drug exposure. The Understanding Compounding Isolators white paper provides additional background for pharmacy teams evaluating CAI and CACI workflows.

For sterile non-hazardous compounding, the PharmaGard NU-PR797 is the appropriate CAI model. It uses positive pressure recirculating airflow to support ISO Class 5 conditions for compounded sterile preparations under USP <797> workflows.

For sterile hazardous drug compounding, NuAire offers the PharmaGard NU-NR800 and PharmaGard NU-NTE800 CACI models. The NU-NR800 is a negative pressure recirculating CACI, while the NU-NTE800 is a negative pressure total exhaust CACI for applications requiring full exhaust connection.

The NU-NR800 is a negative pressure recirculating CACI that partially recirculates HEPA-filtered air and can be connected to facility exhaust through a canopy or air gap transition. The NU-NTE800 is a negative pressure total exhaust CACI that exhausts air through the exhaust HEPA filter housing and must be connected to the facility exhaust system. Use the PharmaGard RABS brochure to compare applications and airflow approaches.

Yes. PharmaGard CAI and CACI systems are engineered to provide HEPA-filtered unidirectional airflow within the work zone and interchange area to support ISO Class 5 conditions during sterile compounding workflows when installed, operated, and certified according to applicable requirements. See the PharmaGard RABS brochure for product-family performance details.

PharmaGard isolators use HEPA-filtered unidirectional airflow across the work zone and interchange area. Properly arranged materials allow first air to bathe critical sites during compounding, helping reduce the risk of contamination and supporting aseptic technique. The Understanding Compounding Isolators white paper is the recommended resource for this educational explanation.

USP <797> applies to sterile compounding and defines requirements for compounded sterile preparations, including use of ISO Class 5 primary engineering controls. USP <800> applies when hazardous drugs are handled and adds requirements for containment, personnel protection, facility design, and engineering controls.

Placement depends on the CSP category and whether hazardous drugs are compounded. Category 1 CSPs may be prepared in an unclassified segregated compounding area when permitted by USP <797>. Category 2 and Category 3 CSPs generally require a cleanroom suite with appropriate classified spaces. Hazardous drug compounding must also follow USP <800> facility and engineering control requirements. For NuAire application context, visit the Sterile Hazardous Drug Compounding or Sterile Non-Hazardous Drug Compounding industry pages.

For sterile hazardous drug compounding, USP <800> requires containment engineering controls and externally vented compounding areas. NuAire's NU-NTE800 is a total exhaust CACI that must be connected to facility exhaust. The NU-NR800 is a recirculating CACI, and NuAire recommends connecting the exhaust airflow to an exhaust system using the appropriate transition and completing a hazardous drug risk assessment.

The transfer chamber allows materials to move into and out of the work zone while helping protect the ISO Class 5 compounding environment. PharmaGard systems use a sliding work tray to support smooth material transfer, and hazardous drug models include interlocked doors to help maintain containment during transfer. See the PharmaGard RABS brochure for a product-family explanation of transfer and work chamber design.

NuAire documentation recommends a minimum one-minute pass-through purge or wait time for material removal in NU-NR800 and NU-NTE800 CACI workflows. Facilities may require longer purge times depending on drug volatility, quantity compounded, and their standard operating procedures. The NU-NTE800 performance evaluation bulletin is a useful technical validation resource.

PharmaGard isolators are designed to support seated or standing operation, with adjustable base stand options, large oval glove ports, expanded work-zone visibility, cool white lighting, open sight lines, and a sliding transfer tray. These features help improve posture, reach, visibility, and daily workflow efficiency. See the PharmaGard RABS brochure for images and feature details.

Yes. PharmaGard systems can be configured with waste and sharps disposal options. These systems allow users to dispose of waste and sharps directly from the sterile work zone through covered negative pressure drop tubes, helping maintain work-zone sterility and exterior containment. See the PharmaGard RABS brochure for workflow visuals.

RABS used for sterile compounding must be certified and verified according to applicable USP, CETA, and facility requirements. USP <797> requires documented recovery time after transfer chamber openings and dynamic airflow smoke pattern testing under operating conditions initially and at least every six months. For certification and service scheduling, contact NuAire Sales and Support.