Protecting Your Team and Your Preparations

Hazardous drug compounding demands more than a cleanroom: it demands a system engineered to contain what cannot be allowed to escape. The PharmaGard™ NU-NTE800 is a negative pressure, total exhaust Compounding Aseptic Containment Isolator (CACI) designed to keep hazardous drug aerosols, vapors, and particulates away from your pharmacists and compounding technicians while maintaining the ISO Class 5 sterile environment your preparations require.

Purpose-built to satisfy the barrier isolator requirements of USP 800 (Pharmaceutical Compounding: Sterile Preparations), the NU-NTE800 also meets NIOSH and ASHP guidelines for hazardous drug handling. Whether you are configuring a new sterile compounding suite or upgrading aging containment equipment, the NU-NTE800 gives your pharmacy the documented compliance foundation and the daily workflow reliability your team depends on.

Two Models for Your Facility Footprint

The NU-NTE800 is available in two widths to match your pharmacy layout and production volume: the NU-NTE800-400 (nominal 4 foot) and the NU-NTE800-600 (nominal 6 foot). Both models share the same depth, height, and interchange dimensions. Download the spec sheet for complete dimensional data, exhaust requirements, and weight specifications for each model.

Containment and Sterility by Design

The NU-NTE800 maintains negative pressure in both the workzone and interchange, with the interchange held at slightly more negative pressure than the workzone, to prevent contamination from migrating into the surrounding environment during preparation transfers. Every surface and seal is engineered around this containment architecture.

HEPA Filtration Throughout

Supply and exhaust HEPA filters achieve 99.99% efficiency on particles 0.3 microns and larger. The full-length supply HEPA filter spans the entire workzone, providing laminar downflow across the worksurface to eliminate cross-contamination. The perforated metal diffuser covers the complete top of both workzone and interchange, distributing supply airflow uniformly. Exhaust filtration uses a Bag-in/Bag-out design with single-point external filter release, eliminating technician exposure during filter changeout.

Positive Pressure Plenum Isolation

All filter positive pressure plenums are surrounded by a vacuum relative to the room. This design ensures that any leak in the supply plenum draws room air inward rather than allowing HEPA-filtered air to bypass filtration. Quick-release supply filter removal allows front/top filter access without disassembling the control panel or hinged window hardware.

ISO Class 5 Workzone and Interchange

The NU-NTE800 delivers better than ISO Class 5 (Federal Standard 209E Class 100) particle counts in both the workzone and the interchange chamber, validated per CETA CAG-002-2006. The interchange is equipped with internal and external sealed doors that interlock: the inner door cannot open when the outer door is open, preserving workzone sterility and negative pressure integrity during every material transfer.

FlowGard™ Control System

The FlowGard™ control system is the operational intelligence of the NU-NTE800. Its OLED display and function keys provide an intuitive interface with multilingual menus, available in English, Spanish, German, French, Chinese, and Japanese. A solid-state DC Motor Controller provides constant volume control, automatically compensating for line voltage variances so airflow performance remains stable across the life of the equipment.

The FlowGard™ system also includes configurable features that must be set during certification: security password protection, filter life and blower hour tracking, UV light hour logging, auto duration timers for LED lights, UV lights, and outlets, and sync functions that coordinate blower, lights, and outlets into unified usage workflows.

Pharmagard™ Digital Monitor with Exhaust Interlock

The integrated Pharmagard™ digital monitor includes a high/low alarm setpoint system with remote alarm dry contact. Its exhaust interlock prevents the workzone and interchange from ever reaching positive pressure, a critical safeguard for compliance with USP 800 and ASHP guidelines. Two minihelic gauges display real-time negative pressure for the workzone and interchange, providing visible verification at every compounding session.

Ergonomics That Support Long Compounding Sessions

Your pharmacists and technicians work at this isolator for hours. The NU-NTE800 is designed to reduce fatigue and support precise, controlled manipulation:

• Hinged lockable polycarbonate window slanted 10° from vertical for optimal gloveport work angle
• Full window opening provides complete access to the entire workzone and interchange for cleaning and setup
• Two independent removable work trays, one for the workzone and one for the interchange, with coved corners for easy cleaning and disinfection
• Large exterior hinged transfer door for efficient product movement into and out of the transfer chamber
• Large interior sliding door for smooth material transfer from interchange to workzone
• Three-position IV bar with 6 hooks
• LED lighting externally mounted, providing a minimum of 40 foot-candles (430 LUX) on the work surface
• Motorized base stand with casters, the standard base configuration for the NU-NTE800, providing mobility and positioning flexibility within the pharmacy

Construction and Electrical

The NU-NTE800 workzone is constructed from welded Type 304 stainless steel, 16-gauge, with a pressure-tight design that maintains the integrity of the negative pressure environment. Cabinet construction allows transport through a standard 36-inch (914 mm) door without disassembly, an important consideration for facilities undergoing renovation or equipment relocation.

Electrical supply is 115VAC, 60Hz via a 12-foot hospital grade power cord (14 GA, 3-wire, 15A). The cabinet includes two independent internal circuits, one for the blower and lights and one for the hospital grade duplex outlet, each protected by a fuse in the Control Center. The DC EC Impeller is optimized for each model width to maximize energy efficiency and filter loading capacity. The NU-NTE800 is UL/UL-C Listed to meet both U.S. and Canadian electrical and mechanical integrity requirements.

Download the NU-NTE800 Spec Sheet

The PharmaGard™ NU-NTE800 purchase specification document (PROCESS #9-1225, Rev 3, October 2024) includes complete dimensional data, performance specifications, electrical requirements, and dimensional drawings for both the 4-foot and 6-foot models. Download it to support your facility planning, RFQ preparation, or compliance documentation.

Download the NU-NTE800 Spec Sheet (PDF)

Frequently Asked Questions

Does the NuAire PharmaGard NU-NTE800 meet USP 800 requirements?

Yes. The NU-NTE800 meets the barrier isolator requirements of USP 800 (Pharmaceutical Compounding: Sterile Preparations) as well as NIOSH and ASHP guidelines for hazardous drug preparations. It maintains negative pressure in both the workzone and interchange, delivers better than ISO Class 5 air quality validated per CETA CAG-002-2006, and uses a total exhaust HEPA filtration system to prevent hazardous drug exposure.

What is the air quality inside the NU-NTE800 workzone?

The NU-NTE800 provides better than ISO Class 5 (equivalent to Federal Standard 209E Class 100) particle counts in both the workzone and interchange. Supply HEPA filtration achieves 99.99% efficiency on particles 0.3 microns and larger, providing laminar downflow across the full workzone length validated to CETA CAG-002-2006 standards.

What exhaust requirements does the NU-NTE800 have?

The NU-NTE800-400 (4-foot model) requires 550 CFM at 2.0" w.g. through a 10-inch (254 mm) exhaust collar. The NU-NTE800-600 (6-foot model) requires 725 CFM at 2.0" w.g. through the same collar size. Both models use a Bag-in/Bag-out exhaust HEPA filter with single-point external filter release to protect personnel during filter changeout.

What base stand options are available for the NU-NTE800?

The NU-NTE800 is available with a motorized base stand with casters, the standard base configuration. The motorized stand provides mobility for positioning within the pharmacy. The cabinet can be transported through a standard 36-inch door without disassembly.

What control and monitoring features does the NU-NTE800 include?

The NU-NTE800 includes the FlowGard™ control system with an OLED display, multilingual menus (English, Spanish, German, French, Chinese, Japanese), solid-state constant volume motor control, and configurable timers. It also includes the Pharmagard™ digital monitor with exhaust interlock, high/low alarm setpoints, remote alarm dry contact, and two minihelic gauges displaying negative pressure in the workzone and interchange.

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