Flow Chart for USP 797 and USP 800 PEC Requirements
14 Nov 2018This infographic presents a flow chart for USP 797 and USP 800 Pec Requirements when preparing drugs in healthcare settings.
This infographic presents a flow chart for USP 797 and USP 800 Pec Requirements when preparing drugs in healthcare settings.

NU-560 Total Exhaust Biological Safety Cabinet (BSC) may be used for work with non-flammable, non-explosive volatile chemicals and radionuclides by providing personnel, product, and environmental protection by exhausting 100% of contaminated air.

The LabGard ES (Energy Saver) TE (Total Exhaust) model NU-565 is an NSF/ANSI 49 Class II, Type B2 Biosafety Fume Hood designed to meet ASHRAE 110 classified to UL 1805 may be used for work with flammable or volatile chemicals and radionuclides required if permitted by chemical risk assessment.

The LabGard (Energy Saver) AIR Limited model NU-545 is an NSF/ANSI 49 certified Class II, Type A2 biological safety cabinet delivering the long-lasting, high-quality performance you and your staff demand to protect you and your work. Safety Automatic Airflow Compensation To maintain safe airflows, the LabGard Limited Edition automatically compensates for both filter loading and line voltage variance to provide you safe, constant airflow protection. HEPEX Zero Leak Airflow System The HEPEX™ Zero Leak Airflow System provides quiet, uniform velocities throughout the entire sterile work zone. All positive pressure chambers and ducts are surrounded by a vacuum or negative air pressure relative to the room. This feature eliminates the possibility of cabinet and gasket leaks. Uneven particulate loading is prevented by maintaining high-static pressure over the entire filter surface assuring True Laminar Airflow. Dynamic Air Barrier Air exchanges within a Class II, Type A2 Biological Safety Cabinet, can occur 25 times per minute. This rapid air exchange system combined with an aerodynamic, ergonomic air foil and a significantly larger access opening creates the strongest air barrier, personnel protection, of any Biological Safety Cabinet. True Laminar Airflow Unidirectional Airflow moving along parallel flow lines at a constant velocity minimizes air turbulence within the work zone. With proper techniques, activities within the work area can be performed safely minimizing the chance of cross-contamination. Technology TouchLink 2.0 Electronic Control System TouchLink™ is an easy-to-use touch screen LCD which will operate and display all system functions. On / off functions for fluorescent and germicidal ultraviolet lights, blower motor, and interior outlets. Monitors high / low limits for down flow, inflow, and sliding window position. The password protected TouchLink ™ also contains a unique date/clock display and timer functions that can be used as a laboratory timer, purge timer, outlet timer, UV light timer, auto-run timer, night setback, or weekend turn-off. TOUCHLINK™ also contains diagnostic functions for a NSF trained service technician or certifier. Real Time Airflow Monitoring Using the same technology as your NSF Accredited Certifier, model NU-545 features digital dual thermistor airflow sensors in the down flow and exhaust flow air to monitor and control real-time airflow ensuring safe airflows based on air velocity instead of pressure inside the plenum. Auto Decontamination The automatic decontamination works in conjunction with hydrogen peroxide, chlorine dioxide, and paraformaldehyde systems. The process simultaneously runs the cabinet blower at a low rate during the decontamination cycle. This will aid in the process of distributing the decontaminant gas/vapor throughout the cabinet during the entire decontamination cycle. Window clamps securely create an air tight seal against an inner window gasket. The inlet port is connected to a connection point on top of the BSC. The outlet port is attached to a fitting on an auto decontamination exhaust seal plate. Lower Total Cost of Ownership Ultra-High Efficiency Motor A single DC ECM motor with an optimally sized fan saves you up to 47% off your electricity bill compared to previously used motor technologies. LED Lighting Exterior LED lighting provides life up to 50,000 hours and is 30% more efficient than standard fluorescent lightning. The LED lighting provides cool white illumination of the work zone from 90 – 120 foot-candles (968 – 1291 lux). Larger, Longer Lasting Filters NuAire offers filters that use more filter media and offer more pleats per square inch. Combined with an ultra-high efficiency motor with more torque, a NuAire BSC can extend the life of a HEPA filter up to 10 years or more. Night Setback As a standard option, upon window closure, the NU-545 may allow the motor to continue to run at a lower rate to continually HEPA filter the work zone. The LED light will be disabled. If the sliding window is then opened, the cabinet will resume normal airflow set points in run mode. Night setback will save your facility money if your standard operating procedures require you to run the BSC 24/7. Design Monolithic Design At the core of any NuAire Biosafety Cabinet is the single piece stainless steel shell. The process starts by bending a single piece of heavy duty stainless steel to create the back and side walls of the cabinet. Additional stainless steel sheets are seam welded into place to create the top and bottom. A smaller sheet of stainless steel is bent and welded into place to create the coved interior work zone. The final step welds the frame work into place to house the motor/blower assembly and HEPA filters. The result is a monolithic shell eliminating the need for rivets, gaskets, and sealants extending product life and enhancing safety. Vibration Control The motor/blower system is suspended inside the BSC using the attenumont system, a shock absorbing technology minimizing vibration transfer from the motor to the cabinet. The HEPEX Zero Leak Airflow System uses an impermeable, antimicrobial, and flameproof flexible fabric to make up the BSC’s plenum eliminating vibration transfer from the motor/blower to the plenum. Clean-ability The interior of the BSC features smooth coved corners for easy clean-ability. A spill trough with drain valve is located under the work surface to catch any unwanted spills. The work surface comes optionally with a prop-up work tray to easily clean under the work surface.

The PharmaGard NTE797 creates a negative pressure clean air [ISO Class 5] total exhaust controlled environment for the aseptic compounding of hazardous drugs. The HEPA filtered work area maintains a negative air pressure relative to the interchange compartment, which operates at a negative air pressure relative to the surrounding room. These levels of protection minimize the possibility of chemotherapy agents or other hazardous materials migrating from the work area into the surrounding room as well as minimizing the possibility of contamination migrating into the work zone.

The PharmaGard NR797 creates a negative pressure clean air [ISO Class 5] re-circulating controlled environment for the aseptic compounding of hazardous drugs. The HEPA filtered work area maintains a negative air pressure relative to the interchange compartment, which operates at a negative air pressure relative to the surrounding room. These levels of protection minimize the possibility of chemotherapy agents or other hazardous materials migrating from the work area into the surrounding room as well as minimizing the possibility of contamination migrating into the work zone.

The LabGard™ ES NU-677 Class II, Type A2 Biological Safety Cabinet / Cage Changing Station offers sterility for animals, procedure work and bio-hazard containment for scientists and technicians; NSF listed to provide personnel, product and environmental protection for sensitive animal handling and cage changing procedures. The NU-677 can be either exhausted back into the room or connected to a facility HVAC system. The cabinet's airflow is 30% exhausted / 70% recirculated to minimize cross-contamination of low to moderate risk biologicals in the absence of volatile toxic chemicals.

LabGard® Air NU-543 Class II, Type A2 Biological Safety Cabinet offers the very best in personnel, product, and environmental protection by monitoring and controlling real-time airflow through the use of an airflow sensor, and displays airflow speeds on the OLED interface. The ability to choose up to three (3) different access opening heights allows our customers the option to select a larger access opening to improve technician movement and reach; select a smaller access opening to lower your total cost of ownership; or select somewhere in-between to get the best of both heights.

The LabGard® ES NU‐540 Class II, Type A2 Laminar Flow Biological Safety Cabinet (LFBSC) is an effective primary engineering control in obtaining the optimum product quality while reducing the potential for exposure of both product and personnel to airborne biological or particulate chemical agents in low to moderate risk‐hazard research and drug preparation. The NU-540 offers economical operation through the use of an ultra high efficiency motor to maximize filter life and monolithic silicone-free construction for long product life.

The PharmaGard PR797 creates a positive pressure clean air [ISO Class 5] controlled environment specifically for aseptic compounding of non-hazardous drugs. The HEPA filtered work area maintains a positive air pressure relative to the interchange compartment, which operates at a positive air pressure relative to the surrounding room. These two levels of protection minimize the possibility of contamination migrating into the work zone.

The AutoLabGard ES (Energy Saver) NU-125 Mini-Room is designed after a Class II, Type A2 Biological Safety Cabinet on a larger scale to provide Class II protection for personnel, product, and the environment. The mini-room can be used for applications involving high-throughput robotic systems, large high-speed cell sorters, ultra-centrifuges, and laboratory equipment requiring Class II protection from potentially harmful aerosols and airborne particles. The NU-125 AutoLabGard ES is constructed with an interior stainless steel floor and wall panels that are gasketed and bolted together. Painted exterior Cold Rolled Steel (CRS) cover panels are gasketed and bolted to the stainless wall panels that make up the negative pressure plenum. Painted CRS blower modules are mounted on top of the wall panels and contain both the supply and exhaust HEPA filters along with the ultra-high efficiency DC ECM motors. Stainless steel doors complete the cabinet enclosure with a hinged window assembly mounted on each door providing an 8 inch (203mm) access opening. If additional access is needed to the interior for user or system interfaces (i.e. power/computer cables, process tubing, etc.), negative pressure pass through ports may be added to the sides or rear of the enclosure that maintain enclosure containment. The airflow pattern of the NU-125 AutoLabGard ES is identical to any class II, type A2 biosafety cabinet. Room air is pulled into the cabinet through the work access opening at an average velocity of 105 fpm (.53 m/s) to provide an air barrier. Engineered with an ultra-high efficiency motor the AutoLabGard lowers operating costs by using less electricity and increasing filter life with less heat output. Each NU-125 is tested and comes with a certified copy to tests consistent with standard NSF/ANSI 49. Contact NuAire today to start your high-throughput robotic system enclosure consultation. Example Application: A perfect match for the BD FACS Airflow Cytometer Laboratory equipment or processes requiring sterility Class II Biological Safety Cabinet protection for robotics