About This Manual

This page provides access to the PharmaGard NU-NR800E Operations & Maintenance Manual (OM0349 Rev 1), the complete reference for installing, operating, and maintaining NuAire’s 230V Compounding Aseptic Containment Isolator. The manual addresses site preparation, start-up procedures, FlowGard control system operation, interchange material transfer, cleaning, sleeve and glove maintenance, HEPA filter replacement, and annual recertification requirements. Download the manual to support onboarding, pharmacy SOP development, and ongoing compliance documentation under USP <800>.

Installation and Site Preparation

Cleanroom Environment and Location

NuAire recommends installing the NU-NR800E in an ISO Class 7 buffer room consistent with USP <800> requirements for hazardous drug compounding environments. Site placement should allow adequate clearance at the rear, sides, and top to support service access and maintain airflow pattern integrity. The operations manual details minimum clearance dimensions and siting guidance for the 1.2 meter (NU-NR800-400E) and 1.8 meter (NU-NR800-600E) configurations.

Exhaust and Ventilation Requirements

The NU-NR800E is a recirculating CACI and does not require a dedicated exhaust duct connection for standard operation. USP <800> requires that the general exhaust of the hazardous drug compounding room be externally vented. NuAire recommends a canopy exhaust transition connected to the room exhaust system to capture any fugitive emissions during HEPA filter service and maintenance. The operations manual specifies canopy exhaust dimensions and connection guidance.

230V Electrical Connection

The NU-NR800E is configured for 230VAC operation. A hospital-grade power cord is supplied with each unit. Consult the operations manual for model-specific electrical requirements, including amperage, circuit protection specifications, and site electrical verification procedures, before installation.

Operating Your PharmaGard NU-NR800E

Start-Up and ISO Class 5 Warmup

Before beginning any compounding session, the NU-NR800E requires a minimum five-minute warmup period with the blower running to achieve and verify ISO Class 5 conditions in the work zone. This warmup is required for every session and should be incorporated into your pharmacy’s standard operating procedures. The operations manual documents the full start-up sequence, display verification steps, and guidance for documenting warmup completion in compliance records.

FlowGard Control System

The FlowGard digital control system manages airflow, monitors system performance, and provides real-time operator feedback through an OLED display. The interface supports six languages: English, Spanish, German, French, Simplified Chinese, and Japanese, accommodating international teams and multi-language healthcare settings.

A DC brushless EC impeller with constant volume control maintains consistent airflow as the HEPA filter loads over time, without manual adjustment. The PharmaGard Digital Monitor tracks work zone and interchange pressure with a digital pressure transducer and green/yellow/red LED status indicators. Configurable high and low pressure alarms alert operators to conditions outside acceptable ranges, supporting continuous containment assurance. Operator controls include security password access, filter life display, blower hour tracking, and auto duration timers.

Interchange Material Transfer Procedure

The interchange provides a separate transfer chamber for moving materials into and out of the work zone without breaking containment. A door interlock prevents the inner door from opening while the outer door is open, preserving the negative pressure differential at all times. The operations manual specifies a minimum one-minute purge cycle after placing materials in the interchange before the inner door may be opened, consistent with compliant compounding practice under CETA CAG-002-2006.

Sleeve and Glove Program

The NU-NR800E uses a nitrile sleeve and glove system as the primary physical barrier between the operator and the hazardous drug work zone. Sleeves should be inspected before each session and replaced at minimum every six months; gloves should be replaced daily or more frequently if damaged or contaminated. The operations manual provides proper donning, doffing, and disposal procedures to support compliance documentation and staff training under USP <800> and NIOSH hazardous drug handling guidelines.

Maintenance and Annual Recertification

Routine Cleaning and Decontamination

The operations manual details cleaning procedures, decontamination protocols, and approved cleaning agents for the NU-NR800E interior surfaces, sleeves, and gloves. Regular decontamination is required under USP <800> and should be incorporated into your pharmacy’s compounding environment procedures. The manual specifies compatible cleaning agents for the polycarbonate window, stainless steel work surfaces, and sleeve port assemblies.

HEPA Filter Inspection and Replacement

Supply and exhaust HEPA filters on the NU-NR800E are rated 99.99% efficient at 0.3 microns. The FlowGard system tracks blower hours and alerts operators as filter replacement intervals approach. Filter replacement must be performed by qualified service personnel following the detailed procedure in the operations manual, which covers safe access, blower shutdown sequence, filter removal, and post-replacement airflow calibration. Contact NuAire Service to schedule filter replacement and maintain continuous compliance.

Annual Recertification

NuAire recommends annual certification testing by a qualified certifier, consistent with CETA CAG-002-2006 requirements and USP <800> compliance documentation practices. Annual testing verifies ISO Class 5 performance, HEPA filter integrity, negative pressure in the work zone and interchange, and certifiable airflow within specification. The operations manual includes certifiable airflow parameters to include in your certification scope. For the complete PharmaGard RABS product family including related CACI configurations, visit the PharmaGard product family page.

Frequently Asked Questions

What does the PharmaGard NU-NR800E Operations & Maintenance Manual cover?

The OM0349 manual covers the complete lifecycle of the NU-NR800E 230V CACI: site preparation and installation requirements, ISO Class 5 warmup and daily start-up procedures, FlowGard control system operation, interchange material transfer protocol, sleeve and glove replacement, cleaning and decontamination, HEPA filter replacement, airflow calibration, and annual recertification parameters for USP 800 and CETA CAG-002 compliant hazardous drug compounding.

What cleanroom environment does the NU-NR800E require for installation?

NuAire recommends installing the NU-NR800E in an ISO Class 7 buffer room consistent with USP <800> requirements for hazardous drug compounding. USP <800> also requires that the room exhaust be externally vented; NuAire recommends a canopy exhaust transition to capture fugitive emissions. Consult the operations manual for minimum clearance requirements, ventilation specifications, and site electrical verification procedures.

What is the required warmup time before compounding with the NU-NR800E?

The NU-NR800E requires a minimum five-minute warmup with the blower running to achieve and verify ISO Class 5 conditions in the work zone before any compounding begins. This warmup applies to every compounding session and should be documented in your pharmacy’s standard operating procedures. The operations manual provides the full start-up sequence and verification steps.

How often do HEPA filters need to be replaced on the NU-NR800E?

Replacement frequency depends on operational use and environment. The FlowGard control system tracks blower hours and alerts operators as filter replacement intervals approach. Supply and exhaust HEPA filters are rated 99.99% efficient at 0.3 microns. Replacement must be performed by qualified service personnel following the procedure documented in the operations manual, which includes safe access, blower shutdown sequence, and post-replacement airflow calibration.

Is annual recertification required for the NU-NR800E?

NuAire recommends annual certification testing by a qualified certifier, consistent with CETA CAG-002-2006 requirements. Annual testing verifies ISO Class 5 performance, HEPA filter integrity, negative pressure in the work zone and interchange, and certifiable airflow within specification. Annual recertification supports USP <800> compliance documentation. The operations manual includes certifiable airflow parameters for inclusion in your certification scope.

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