CELLGARD ES Energy Saver Class II Laminar Flow Biological Safety Cabinet
CELLGARD ES Energy Saver Class II Laminar Flow Biological Safety Cabinet
Models
NU-477-300E/400E/500E/600E
Bench/Console
November 2015
(Series 5 and Higher)
Revision 6
NU-477-400E/500E/600E Only
Manufactured By:
NuAire, Inc.
2100 Fernbrook Lane
Plymouth, MN 55447
Toll-Free: 1-800-328-3352
In Minnesota: (763)-553-1270
Fax: (763)-553-0459
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Congratulations!
You have just purchased one of the finest Laminar Flow Biological Safety Cabinets available. With proper care, maintenance
(testing), and laboratory procedure, this cabinet will give you years of product and personnel protection from particulate
contaminants as prescribed in NSF/ANSI 49 and EN12469. Please read this manual carefully to familiarize yourself with proper
installation, maintenance, and operation of the cabinet.
www.hc-sc.gc.ca
www.cdc.gov/od/ohs/
www.absa.org
www.absa-canada.org
www.ebsa.be
www.inspection.gc.ca
www.who.int
www.biosafety.be
www.hse.gov.uk
www.nsf.org
www.cetainternational.org
www.osha.gov/dts/osta/
www.nuaire.com
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ABOUT THIS OPERATION & MAINTENANCE MANUAL
The information contained in this manual is intended to reflect our current production standard configuration model
along with the more frequently purchased options. Any unique additions/modifications/shop drawings are appended in the back
flap of this manual, along with any modifications and/or additions to procedures as outlined in this manual. A copy of the original
factory test report is also appended to this manual. In case this manual and/or test report is lost or misplaced, NuAire retains a copy
in our files. A replacement copy can be obtained by calling or writing NuAire, Inc. stating the model number and serial number and a
brief description of the information desired.
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CELLGARD ES Energy Saver Class II Laminar Flow Biological Safety Cabinet
Models NU-477-300E/400E/500E/600E Operation & Maintenance Manual
TABLE OF CONTENTS
Section No. 1 ..............................................................General Description
Section No. 2 ..............................................................Models & Features
Section No. 3 ..............................................................Warranty
Section No. 4 ..............................................................Shipments
Section No. 5 ..............................................................Installation Instructions
5.1 ................................................................................ Location
5.2 ................................................................................ Set-up Instructions
5.3 ................................................................................ Testing Methods and Equipment
Section No. 6 ..............................................................Operating the NU-477E
6.1 ................................................................................ Operator Controls & Indicators
6.2 ................................................................................ Operating Guidelines
6.3 ................................................................................ Operating Sequence
6.4 ................................................................................ Ergonomics
6.5 ................................................................................ Cleaning Procedures
6.6 ................................................................................ Hazardous Decontamination Procedure
Section No. 7 ..............................................................General Maintenance
7.1 ................................................................................ Decontamination
7.2 ................................................................................ Fluorescent Lamp, Bulb Replacement
7.3 ................................................................................ HEPA Filter/Motor Replacement
7.4 ................................................................................ Sliding Window Replacement & Adjustment
7.5 ................................................................................ Airflow Calibration
7.6.................................................................................. HEPA Filter Leak Test
7.7 ................................................................................ Airflow Smoke Pattern Test
7.8 ................................................................................ Cleanliness Classification Test for Pharmacy Application
7.9.................................................................................. Main Control Board Description & Replacement
Section No. 8 ..............................................................Error Indicators & Troubleshooting
Section No. 9 ..............................................................Remote Contacts
Section No. 10 ............................................................Optional Equipment
10.1 .................................................................................. Ultraviolet Lamp
Section No. 11............................................................Electrical/Environmental Requirements
Section No. 12 ...........................................................Disposal and Recycle
Insert.............................................................. ............Replacement Parts
MANUAL DRAWINGS
ACD-16006 ........................................................................ NU-477E Airflow Schematic
BCD-16007 ........................................................................ NU-477-300E Specification Drawing
BCD-16008 ........................................................................ NU-477-400E Specification Drawing
BCD-16009 ........................................................................ NU-477-500E Specification Drawing
BCD-16010 ........................................................................ NU-477-600E Specification Drawing
BCD-12634 ........................................................................ NU-477E SST Cap/Security Drain Valve Installation
BCD-12056 ........................................................................ Front Panel
ASSEMBLY DRAWINGS
BCD-05147 ........................................................................ Base Stand Assembly
BCD-05146 ........................................................................ Base Stand Storage Cabinet Assembly
BCD-11817 ........................................................................ Control Center & Front Decorative Panel Assembly
BCD-15926 ........................................................................ Sliding Window Assembly & Adjustment
BCD-11819 ........................................................................ Base Cabinet Assembly
ELECTRICAL SCHEMATICS
BCD-13276 ........................................................................ Main Control Module Schematic
BCD-14300 ........................................................................ NU-477-300E/400E/500E/600E Electrical Schematic
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CELLGARD ES Energy Saver Class II Laminar Flow
Biological Safety Cabinet
Models
NU-477-300E/400E/500E/600E
MANUFACTURED BY:
NuAire, Inc. - Plymouth, Minnesota, U.S.A.
1.1 Description
The CELLGARD ES Model NU-477E Laminar Flow Biological Safety Cabinet (LFBSC) is a bench/table top model, optionally
available with a base support stand, for operation as a console model. The CELLGARD ES Model NU-477E utilizes an Energy
Saver DC ECM Motor optimally determined forward curved fan for each model size/width to maximize both energy
efficiency and filter loading capacity. The Energy Saver ECM Motor is controlled to airflow setpoints via a solid-state DC
motor controller with digital dual thermister airflow sensors that provide an automatic compensation (constant volume
control) for both filter loading and line voltage variances.
The Laminar Flow Biological Safety Cabinet, (LFBSC) is a product resulting from the development of the "laminar flow"
principle (see airflow schematic) and the application of environmental controls as required in the field of biological research
or chemical containment. The LFBSC, when used with proper technique, is an effective laboratory aid in obtaining the
optimum control over 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 or product
operations, as prescribed by the Center for Disease Control (CDC) Atlanta, Georgia.
The NU-477E bench LFBSC meets the requirements of a Class II, since the cabinet conforms to the following requirements:
1. Maintains an average inflow velocity of 100 LFPM (.51 M/S) through the work access opening.
2. Has HEPA filtered downflow air that is mixed with the inflow air from a common exhaust plenum.
3. Discharges a percentage of air to the outside atmosphere after HEPA filtration.
4. Has all biologically contaminated ducts and plenums under negative pressure or surrounded by negative pressure.
Cabinets used for work with minute quantities of volatile toxic chemicals and trace amounts of radionuclides required as an
adjunct to microbiological studies must be exhausted through properly functioning exhaust canopies.
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1.3 Explanation of Symbols
Biohazard
Hazardous Gases! Personal
Protection Equipment Required.
Ground, Earth
Chemical Hazard
Lead Free
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2.0 Models & Features
The model NU-477E, CELLGARD ES Class II Laminar Flow Biological Safety Cabinet is manufactured in
four sizes: 3 ft.(.9m), 4 ft.(1.2m), 5 ft.(1.5m), and 6 ft.(1.8m).
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3.0 Warranty
NuAire, Inc. warrants Class II w/ECM Motor (CELLGARD ES) that it will repair F.O.B. its factory or furnish without charge
F.O.B. its factory a similar part to replace any material including HEPA filters in its equipment within 60 months after the
date of sale if proved to the satisfaction of the company to have been defective at the time it was sold provided that all
parts claimed defective shall be returned, properly identified to the company at its factory, charges prepaid. Factory
installed equipment or accessories are warranted only to the extent guaranteed by the original manufacturer, and this
warranty shall not apply to any portion of the equipment modified by the user. Claims under this warranty should be
directed to NuAire, Inc. setting forth in detail the nature of the defect, the date of the initial installation and the serial and
model number of the equipment.
This warranty shall not apply to any NuAire product or part thereof which has been subject to misuse, abuse, accident,
shipping damage, improper installation or service, or damage by fire, flood or acts of God. If the serial number of this
product is altered, removed or defaced as to be illegible, the Warranty shall be null and void in its entirety.
The warranty is for the sole benefit of the original purchaser and is not assignable or transferable. Prior to returning any
item, for any reason, contact NuAire for a Return Authorization Number. This number must accompany all returns. Any
product shipped to NuAire without this number will be returned refused shipment or collect freight.
4.0 Shipments
NuAire takes every reasonable precaution to assure that your CELLGARD ES cabinet arrives without damage. Motor carriers
are carefully selected and shipping cartons have been specially designed to insure your purchase. However, damage can
occur in any shipment and the following outlines the steps you should take on receipt of a NuAire CELLGARD ES cabinet to
be sure that if damage has occurred, the proper claims and actions are taken immediately.
4.1.1 Terms are factory, unless stated otherwise. Therefore, it is important to check each shipment before acceptance.
4.1.2 If there is visible damage, the material can be accepted after the driver makes a notation on the consignee's copy
of the freight bill. Then an inspection must be made to verify the claim against the carrier. This inspection is the
basis of your filing the claim against the carrier.
4.1.3 If concealed damage is found, it is absolutely necessary to NOTIFY THE FREIGHT AGENT AT ONCE, and request an
inspection. Without this inspection, the transportation company may not accept a claim for loss or damage. If the
carrier will not perform the inspection, an affidavit must be prepared stating that he was contacted on a certain
date and that he failed to comply with the request. This along with other papers in the customer's possession will
support the claim.
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5.0 Installation Instructions
5.1 Location
Within the laboratory, pharmacy, etc., the ideal location of the biological safety cabinet is away from personnel traffic
lanes, air vents (in or out), doors and/or any other source of disruptive air currents.
THE EXHAUST FILTER AREA IS ESPECIALLY SUSCEPTIBLE TO DISRUPTIVE AIR CURRENTS FROM AIR VENTS. The Electronic
Airflow Control System's exhaust probe is located just above the exhaust HEPA filter and if disruptive air currents are
present, the exhaust probe could be influenced by them, and indicate disruptive readings on the front panel display.
If drafts or other disruptive air currents exceed the inflow velocity of the cabinet through the access opening, the potential
exists for contaminated air to exit or enter the work zone area of the cabinet. It depends on the severity of the air current.
REMEMBER: A BIOLOGICAL SAFETY CABINET IS NO SUBSTITUTE FOR GOOD LABORATORY TECHNIQUE.
Where space permits, a clear 6" (152mm) area should be permitted on each side of the cabinet for maintenance purposes.
The electrical outlet into which the cabinet is connected should be readily accessible for maintenance purposes. Do not
position the cabinet to prevent access to the power cord. The power cord plug serves as the disconnect and should
remain readily accessible. If the outlet is inaccessible, such as a conduit (hardwired) connection, then an appropriate
warning label should be applied near the cabinets on/off switch to indicate the circuit breaker on the power distribution
panel should be used. A MINIMUM CLEARANCE OF 6" (152MM) IS REQUIRED FROM THE TOP OF THE CABINET TO THE
CEILING FOR PROPER VENTILATION OF THE EXHAUST EFFLUX.
If this cabinet is used in a pharmacy application, Per OSHA, NIOSH, and ASHP, it is strongly recommended that the cabinet
be exhausted to the outside. In addition, if this cabinet is used in microbiological application with minute quantities of
volatile toxic chemicals and tracer amounts of radionuclides, Per CDC/NIH and NSF it is strongly recommended that the
cabinet be exhausted to the outside. NuAire offers two general categories of exhaust transitions, which will capture the
exhaust efflux from the cabinet. These are:
Canopy, Thimble or Air Gap Exhaust Transitions (with and without integral fan)
NuAire strongly recommends a canopy or thimble exhaust for most applications. See separate instruction sheets for a
discussion of exhaust transitions and installation requirements.
NOTE, some countries (i.e. Germany) only allow canopy or thimble type transitions. Verify requirements per Local,
State and Federal code laws.
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5.2 Set-Up Instructions
Remove outer shipping protection (carton or crating). The cabinet is fastened to the base skid and it is usually the best
procedure to leave the skid in place until the cabinet is located in its approximate position to facilitate ease in handling. It
can then be removed from the skid by removing the banding, bolts and screws holding the cabinet to the skid. It may be
necessary to remove the Control Center in order to gain passage through a doorway. It may easily be removed by following
the instructions on drawing
BCD- 11817.
The base stand storage cabinets will usually be shipped according to customer requirements. If it is shipped
unassembled, it can be assembled per drawing BCD-05146. It is recommended that the upper and lower base
stand braces be installed first, then the rear and bottom panels (the end panels are always prefastened). Once
assembled, fasten the cabinet per the above instructions.
5.2.2 Leveling
Using a level placed on the work tray, adjust the leg levelers, first, end to end, then, front to back. The NSF
approved leg levelers provide a 3/4" (20mm) adjustment.
If a security drain valve is desired, (NOTE, CHECK WITH YOUR SAFETY PERSONNEL FOR REGULATORY
REQUIREMENTS (i.e. LOCKING TYPE) OF DRAIN VALVE INSTALLATION) remove the handle from the valve stem
with security tool provided to gain clearance for valve body rotation. Add Loctite 242 (furnished) to the threads
and rotate valve body until secure, with the valve stem (for handle) on the left side. Re-install handle to valve
stem. Adjust the cabinet on bench to provide a 2" (51mm) overhang and seal the interface of the bench and
cabinet, using RTV caulk as above.
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5.2.4 Gas Service
NuAire doesn't recommend the use of natural gas within the BSC, but if gas service is determined to be necessary
for the application, appropriate safety measures must take place. All NuAire BSC's have precautionary warning
labels that say the following:
Once the determination has been made by the appropriate safety personnel, the application of natural gas must
be performed in accordance to national, state and local codes. IT IS ALSO STRONGLY RECOMMENDED THAT AN
EMERGENCY GAS SHUTOFF VALVE BE PLACED JUST OUTSIDE THE BSC ON THE GAS SUPPLY LINE.
The gas valve, when this option is installed, will only operate or flow gas when the cabinet blower is on and no
alarm is present. A solenoid valve is installed on the gas supply line for this purpose.
NOTE, some countries (i.e. Germany) only allow certain types of certified valves to be used for natural gas (i.e.
Germany DVGW Certified). Verify requirements per Local, State and Federal codes/laws.
As previously stated NuAire doesn't recommend the use of natural gas within the BSC and ASSUMES NO
RESPONSIBILITY FOR ITS USE. USE AT YOUR OWN RISK. The Bunsen burner flame within the BSC not only
contributes to heat build-up; is also disrupts the laminar air stream, which must be maintained for maximum
efficiency. IF THE PROCEDURE DEMANDS USE OF A FLAME, A BUNSEN BURNER WITH ON DEMAND IGNITION IS
STRONGLY RECOMMENDED. DO NOT USE CONSTANT FLAME GAS BURNERS. During use, the Bunsen burner
should be placed to the rear of the workspace where resulting air turbulence will have a minimal effect.
External connection is to 3/8 inch NPT coupling in the inner sidewalls. Connection to plant utilities should be made
with proper materials for the individual service and according to national and/or local codes. Observe all labels
pertaining to the type of service and operating pressure.
PLEASE NOTE, THIS UNIT CONTAINS ELECTRONIC BALLASTS FOR THE FLUORESCENT LIGHTING. ELECTRONIC
BALLASTS OPERATE WITH HIGH INRUSH CURRENT. IT IS NOT RECOMMENDED TO USE THIS PRODUCT WITH
GROUND FAULT CIRCUIT INTERRUPTERS (GFCI'S) BECAUSE THE BALLASTS MAY CAUSE THE GFCI TO TRIP.
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5.2.7 Final Assembly
Remove the protective cardboard cover over the exhaust HEPA filter, located under the protective screen if in
place. Attach the exhaust sensor shroud over the exhaust sensor. The shroud should be placed as close as possible
to the exhaust HEPA filter without coming in contact. The probe gasket should be tightly against the sensor shroud
to prevent sneak airflow paths. The exterior surface and viewing glass are easily cleaned with any mild household
detergent cleaner using a soft cloth. Harsh chemicals, solvent-type cleaners and abrasive cleaners should not be
used.
Do not attempt to clean the HEPA filter media. Cabinet interior walls or work surface are easily cleaned with any
mild household detergent cleaner using a soft cloth. Turn the cabinet on and let it operate for 60 minutes before
using it as a LFBSC.
IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED TECHNICIAN WHO IS FAMILIAR WITH THE
METHODS AND PROCEDURES FOR TESTING BIOLOGICAL SAFETY CABINETS (SEE INSERT).
AFTER THE INITIAL INSTALLATION TEST, NUAIRE RECOMMENDS THAT THE CABINET BE RETESTED AT A MINIMUM ON AN
ANNUAL BASIS AND AFTER EVERY FILTER CHANGE OR MAINTENANCE ACTION OR ANY TIME THE OPERATOR FEELS IT IS
NECESSARY.
Note that the CELLGARD ES cabinets, filters and seals provide premium performance; Quality Control in both design and
manufacturing assure superior reliability. However, protection to both product and operator is so vital that testing to the
performance requirements should be accomplished as stated to ensure biological safety established by the factory
standards.
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Cellgard ES Energy Saver Class II
Laminar Flow Biological Safety Cabinet
Models NU-477-300E/400E/500E/600E
Catalog Number
Catalog Number NU-477-300E NU-477-400E NU-477-500E NU-477-600E
Nominal 3 foot (0.9m) Nominal 4 foot (1.2m) Nominal 5 foot (1.5m) Nominal 6 foot (1.8m)
Performance Specifications
NSF/ANSI 49 NSF/ANSI 49 NSF/ANSI 49 NSF/ANSI 49
1. Personal Protection
EN 12469 EN 12469 EN 12469 EN 12469
2. Product Protection
EN 12469 Class Class II Class II Class II Class II
Bench top/console w/base Bench top/console w/base Bench top/console w/base Bench top/console w/base
Style of Cabinet
stand/storage cabinet stand/storage cabinet stand/storage cabinet stand/storage cabinet
All welded stainless steel All welded stainless steel All welded stainless steel All welded stainless steel
Cabinet Construction 16GA, Type 304 16GA, Type 304 16GA, Type 304 16GA, Type 304
pressure tight design pressure tight design pressure tight design pressure tight design
Diffuser for Air Supply (Metal) Non-flammable Non-flammable Non-flammable Non-flammable
HEPA Filter Seal Type:
Supply Filter-99.99% Eff. on 0.3 microns HEPEX Seal HEPEX Seal HEPEX Seal HEPEX Seal
Exhaust Filter-99.99% Eff. on 0.3 microns Neoprene, Spring-loaded Neoprene, Spring-loaded Neoprene, Spring-loaded Neoprene, Spring-loaded
Fumigation : per EN 12469, Annex J
Yes Yes Yes Yes
Procedure
Standard Services:
Service Coupling (3/8 inch NPT) One, Right Sidewall One, Right Sidewall One, Right Sidewall One, Right Sidewall
Gas Valve/Service Coupling (3/8inch NPT) One, Right Sidewall One, Right Sidewall One, Right Sidewall One, Right Sidewall
Outlet Two, Backwall Two, Backwall Two, Backwall Two, Backwall
Optional Services:
Gas Cocks 3/8" NPT Up to 3 ea. Sidewall Up to 3 ea. Sidewall Up to 3 ea. Sidewall Up to 3 ea. Sidewall
Ultraviolet Light One, Backwall One, Backwall One, Backwall One, Backwall
Standard/Cup Sinks Lt or Rt. Work Surface Lt or Rt. Work Surface Lt or Rt. Work Surface Lt or Rt. Work Surface
Cabinet Size Inches (mm):
Height (Fully Assembled) 61 7/8 (1572) 61 7/8 (1572) 61 7/8 (1572) 61 7/8 (1572)
Height (Minimum for Transport) Width 59 (1499) 59 (1499) 59 (1499) 59 (1499)
Depth (with Control Center) 41 5/8 (1057) 53 5/8 (1362) 65 5/8 (1669) 77 5/8 (1972)
And Armrest Removed 33 (838) 33 (838) 33 (838) 33 (838)
Work Access Opening Inches (mm):
Standard Opening Height/Optional 8 (203) 8 (203) 8 (203) 8 (203)
Standard Inflow Velocity 105 FPM (.53 m/s) 105 FPM (.53 m/s) 105 FPM (.53 m/s) 105 FPM (.53 m/s)
Work Zone Inches (mm):
Height 28 1/2 (724) 28 1/2 (724) 28 1/2 (724) 28 1/2 (724)
Width 34 3/8 (873) 46 3/8 (1178) 46 3/8 (1178) 70 3/8 (1788)
Depth measured at 8 inches (102mm) 26 1/8 (664) 26 1/8 (664) 26 1/8 (664) 26 1/8 (664)
window height
Viewing Window Inches (mm): Fully closed to Fully closed to Fully closed to Fully closed to
Standard is tempered sliding glass 18 (457) open 18 (457) open 18 (457) open 18 (457) open
Required Exhaust CFM (CMH) CFM (CMH) CFM (CMH) CFM (CMH)
Canopy Variable Range (NU-911) 225-450 (383-765) 295-520 (502-884) 365-590 (621-1003) 436-661 (741-1124)
Canopy Fixed Range (NU-907) 269 (457) 359 (610) 445 (756) 532 (904)
Plant Duct Static Pressure Eng./Metric 0.05-0.1"/1.27-2.54mm 0.05-0.1"/1.27-2.54mm 0.05-0.1"/1.27-2.54mm 0.05-0.1"/1.27-2.54mm
H2O H2O H2O H2O
Heat Rejected, BTU, Per Hour (non- 826 1020 1611 1768
vented) 120 157 198 198
(vented)
Electrical: (CE marked):
Volts, AC 50/60 Hz 230 230 230 230
+Amps: Blower/Lights 1.0 1.3 2.0 2.2
Amps: Each Outlet 3 3 3 3
Amps: Total 6 10 11 11
12 ft. Power Cord (one) 14 GA - 3 Wire, 15A 14 GA - 3 Wire, 15A 14 GA-3 Wire, 15 A 14 GA-3 Wire, 15 A
Crated Shipping Weight:*** 475 lbs. /215 kg. 550 lbs. /249 kg. 650 lbs. /295 kg. 730 lbs. /331 kg.
Net Weight 425 lbs. /193 kg. 500 lbs. /227 kg. 600 lbs. /273 kg. 680 lbs. /308 kg.
Sound Pressure Level per ISO 4871**** Not to Exceed 55 dbA ■ Not to Exceed 56 dbA ■ Not to Exceed 58 dbA ■ Not to Exceed 60 dbA ■
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6.0 Operating the NU-477E
6.1.1 Overview
The electronic control system is designed to service the control requirements of the NU-477E Biological Safety
Cabinet. The control system consists of two electronic modules that will perform the following functions:
Control blower via solid state switch.
Control lights via solid state switch.
Control outlets via solid state switch.
Control blower DC ECM Motor with solid-state DC Motor Controller that provides automatic compensation
(constant volume control) for both filter loading and line voltage variances.
Monitor and display airflow system performance via Flow Gard monitor.
Airflow system alarm setpoints high/low via Flow Gard monitor.
The NU-477E incorporates the use of two electronic modules that improves the cabinet's performance. The Flow
Gard monitor uses a dual thermistor airflow probe located in the exhaust airflow to monitor the cabinet system
function. The Flow Gard monitor indicates through LED's normal operation, as well as high alarm status (HEPA
filter loading) and low alarm status (low airflow). The main control module, through the use of the front panel,
controls the on/off functions of the blower, fluorescent and ultraviolet (optional) lights, and outlets. The main
control module also monitors the sliding window position with a microswitch for both window high and closed
(interlocks optional UV light) positions. Lastly, the main control module includes fan relay contact closures for
interaction with HVAC systems to optimize environmental performance. All the above functions are shown in a
system block diagram (see Figure 1).
Figure 1
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6.1.2 Front Panel
The control system front panel contains the following functions described in detail (See Drawing BCD-12056).
The blower LED will also blink when both the sliding window is fully closed and the blower "on"
switch has been depressed.
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6.1.3 Run Mode Operation
Operation of the cabinet is initiated by plugging the power cord into the appropriate line power. In the power off
condition (cabinet is unplugged); all calibration and running parameters will be stored in the microprocessor's
EEPROM memory. During the power on condition (cabinet is plugged in), the cabinet's blower, lights, and outlet
may be turned on. The Flow Gard monitor will automatically turn on when the blower is on.
The airflow calibration mode provides a means of adjusting the curve starting point, if necessary, at any point
of the filter loading process. The airflow calibration mode accessed and exited through a front panel key
sequence allows adjustment to achieve the desired airflow. At that point the current RPM and PWM values
will be stored as the starting point for further airflow operation.
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6.1.3.3 Blower Password Protection/Night Setback Mode
The blower is operated by using a password (a sequence of 3 key strokes) in combination with or without the
night setback mode. The night setback mode allows the DC ECM motor to continue to run at a lower rate with
the sliding window closed allowing the workzone interior to be continually HEPA filtered. If the night setback
mode is selected (JP3), the blower switch must be on and the window closed for it to be activated. In other
words, if JP3 is on, the night setback mode will indicate when the window is closed, (or with about 1/4” gap
between the bottom of the window and the armrest). If JP3 is off the motor will shut off when the window is
closed.
A combination of 3 jumpers on the control board will activate either the password and/or the night setback
mode operation. The jumpers are located and labeled J1, J2, and J3 on the control board. The key stroke
password sequence is a selected combination of the hidden key (blower symbol), blower on and blower off.
The table below indicated the jumper combinations and their associated password with or without the night
setback mode.
(Default in bold)
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6.1.4 Flow Gard Operation
6.1.4.1 Overview
The Flow Gard monitor uses a dual thermister airflow probe located in the exhaust airflow to monitor the
cabinet system function. The Flow Gard monitor indicates through LED's normal operation (green), as well as
high alarm status (red) (Hepa filter loading) and low alarm status (red) (low airflow). All user interaction is
accomplished through the arrow and reset keys. IT IS RECOMMENDED THAT THE FLOW GARD BE
CALIBRATED ANNUALLY DURING THE TESTING PROCESS.
Procedure protocols defined in terms of the barrier or control concepts unique to LFBSC must be developed in order to
obtain a maximum potential for safety and protection. The pre-planning necessary to develop these protocols is based on
several fundamental considerations, each of which will contribute to optimum benefits from the equipment:
a. Know your "safe working area"
b. Minimize disruption of "air curtain"
c. Minimize room activity
d. Utilize unidirectional air flow
e. Employ aseptic techniques
NOTE: It is important to maintain an air gap on both sides of the worktray before fastening in place.
The work tray as being part of the cabinet system has been designed to load up to 100 lbs. (45.4 kg)
of work materials. Any additional loading should be evaluated by appropriate safety personnel.
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6.2.2 Minimize Penetration of "Air Curtain"
The minimum number of items necessary should be placed into the cabinet to prevent overloading, but the work
should also be planned to minimize the number of times an operator's hands and arms must enter and leave the
air curtain at the open face. The ideal situation is to have everything needed for the complete procedure placed in
the hood before starting, so that nothing need pass in or out through the air barrier at the face until the procedure
is completed. This is especially important in working with moderate risk agents.
Unnecessary rising of the hands inside the cabinet above the level of the work opening should be avoided. This
presents an inclined plane from hands to elbows along which the downflow of air may run to, and possibly out, the
open face.
Note: When working with agents of lower risk, it is not as important for all materials to be placed in the cabinet before
starting, or for the procedure to be completely finished before materials are removed. Also, the time period for a
unit may be continued over a more extended period during which entries and withdrawals from the cabinet may
be made.
A solid object placed in a laminar air stream will disrupt the parallel flow and consequently, the capability of
controlling lateral movement of airborne particulates. A cone of turbulence extends below the object and
laminarity of the air stream is not regained until a point is reached downstream, approximately equal to three to
six times the diameter of the object. Within the parameters of this cone, particles may be carried laterally by
multidirectional eddy currents.
Transfer of viable materials and manipulations which may generate aerosols should not be performed above
sterile or uninoculated materials. Items should be localized on the work surface in "clean" and "dirty" groups.
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6.2.5 Employ Aseptic Technique
The operator must not assume an attitude of "let the cabinet do it" when performing procedures within a LFBSC.
Properly balanced and properly used cabinets will do an excellent job of controlling airborne contamination and
containing viable agents, but the cabinet will not eliminate contact transmission of contamination. Normal
laboratory contamination control procedures and basic aseptic techniques are necessary to obtain maximum
benefit from the cabinet. For example, open bottle, tube or flask mounts should be kept as parallel as possible to
the downflow to minimize capture of chance particulates. This precaution is merely an extension of good aseptic
technique as practiced on open bench tops. The good laboratory practices designed to minimize creation and/or
release of aerosols to the environment should not be discontinued.
Items of equipment in direct contact with the etiologic agent must remain in the cabinet until enclosed or until
surface-decontaminated. Trays of discard pipettes must be covered before removal from the cabinet (aluminum
foil may substitute for fabricated covers).
If an accident occurs which spills or splatters suspensions of etiologic agent around the work area, all surfaces and
items in the cabinet must be surface-decontaminated before being removed.
Applying a burner flame to flask and tube necks when mating surfaces of sterile assemblies is a conventional
method of minimizing chance contamination. However, the efficiency of this operation is usually related to the
removal of airborne contamination occurring while the item is uncovered. If the manipulation is carried out in an
environment free of airborne particulates, then the need for the flaming operation is essentially removed. This is
one of the additional advantages of the LFBSC - use of the gas burner is seldom necessary. The gas burner flame in
one of these units not only contributes significantly to the heat build-up, it also disrupts the laminar air streams
which must be
maintained for maximum efficiency. If the procedure demands use of a flame, A BUNSEN BURNER WITH ON
DEMAND IGNITION IS RECOMMENDED. DO NOT USE CONSTANT FLAME GAS BURNERS. It should also be placed
to the rear of the workspace where resulting air turbulence will have a minimal effect. If cabinet air is inadvertently
turned off, the flame could damage the HEPA filters.
6.3.1 Start Up
Turn on cabinet blower and lights, check air intake and exhaust portals of the cabinet to make sure they are
unobstructed.
Note: Some cabinets are equipped with ultraviolet (UV) lights. Good procedure includes the decontamination or
wipedown of cabinet surfaces with chemical disinfectant before work commences. This practice eliminates the
need for UV lights, whose primary utility in this application is inactivation of surface contamination since the filters
effectively remove all airborne contaminants. UV lights, therefore, are not recommended in the LFBSC.
Allow blowers to operate for a minimum of 15 minutes before aseptic manipulations are begun in the cabinet. If
the filtered air exhausted from the unit is discharged into the room, as in some installations, an additional
advantage is obtained from purification (filtration) of the room air circulated through the equipment. Because of
this characteristic contributing to the quality of the laboratory environment, some owners of LFBSC leave them in
operation beyond the time of actual use.
6.3.2 Wipedown
The interior surfaces of the work space should next be disinfected (see Cleaning Procedures section) by wiping
them thoroughly with 70% alcohol or similar non-corrosive anti microbial agents. USE OF CHLORINATED OR
HALOGEN MATERIALS IN THE CABINET MAY DAMAGE STAINLESS STEEL.
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6.3.4 Air Purge
Additional purging of the workspace without user activity should be allowed for 2-3 minutes after materials and
apparatus have been placed in it. This will rid the area of all "loose" contamination that may have been introduced
with the items.
a. A sterile plastic-backed absorbent drape should be placed on the work surface during mixing procedures.
The drape should be exchanged whenever significant spillage occurs, or at the end of each production
sequence.
b. Vials should be vented with a filter needle to eliminate internal pressure or vacuum.
c. Before opening ampoules, care should be taken to insure that no liquid remains in the tip of the ampoule.
A sterile gauze sponge should be wrapped around the neck of the ampoule while opening.
d. Final drug measurement should be performed prior to removing the needle from the stopper of the vial.
e. A non-splash collection vessel should be available in the biological safety cabinet to discard excess drug
solutions.
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6.4 Ergonomics
Ergonomics, the study or accommodation of work practices is extremely important for proper cabinet usage and user
health and safety. An evaluation of normal work practices should be performed with each user when working in a cabinet.
Evaluation criteria should be at a minimum:
a. Proper user posture
b. Effective workzone layout for work practice
c. Vision or sightlines
For each of the above evaluation criterion, several work aids may be supplied to accommodate the user.
Ergonomic chair - A six-way articulating seat and back control for personalized adjustment to assure proper user
posture. Be sure feet are resting on the floor, chair foot support or foot rest. Also be sure back is fully supported
with proper chair adjustments.
Forearm/elbow support - The cabinet is provided with a non-metallic forearm support on the work access opening.
Periodic mini-breaks during work practice should be taken resting forearm to avoid stress and fatigue. Elbow rests
are optional that can provide support for particular work practices, such as pipetting. Also available as an option,
closed cell foam disposable forearm pads to reduce pressure points and add comfort.
Effective workzone layout - Always prepare your work procedure to minimize reach to avoid neck and shoulder
stress and fatigue. Rotating tables are optional to maximum workzone and minimize reach.
Vision and sightline - Always prepare your work procedure to eliminate glare and bright reflections on the window.
Keep your window clean and sightlines clear to your effective workzone.
NOTE: DISINFECTANTS THAT USE CHLORIDES AND HALOGENS WILL CAUSE DAMAGE TO THE STAINLESS STEEL
SURFACES IF LEFT ON FOR LONG PERIODS OF TIME.
d. After the specified contact time, wipe up excess disinfectant. IF THE DISINFECTANT USED CONTAINS CHLORIDES
OR HALOGENS, RE-WIPE ALL SURFACES WITH 70% ALCOHOL OR SIMILAR NON-CORROSIVE ANTI-MICROBIAL
AGENT TO PREVENT DAMAGE TO STAINLESS STEEL SURFACES.
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6.6 Hazardous Drug Decontamination Procedures
This procedure is intended to provide guidance following a spillage and/or periodic maintenance, testing or relocation of
the cabinet. Additional guidance can be provided by the CETA document CAG-005-2007 found at the CETA website:
www.CETAinternational.org.
6.6.1 Preparation
Prior to beginning decontamination activity, personnel should wear proper personnel protection equipment (PPE)
1
i.e. Tyvek isolation gown, 2 pair of Nitrile gloves and a full-faced HEPA filtered respirator. All protective garments
should be contained in 4 mil plastic bags and labeled for disposal as chemotherapy waste after completion of the
procedure. For the purpose of this procedure, detailed procedures for cleaning a Class II BSC can be found in the
2
1990 ASHP Technical Assistance Bulletin Guidelines on Handling Cytotoxic and Hazardous Drugs .
6.6.2 Procedure
a. Make sure that the cabinet remains in operational mode with internal blower on.
b. Open the hinged or sliding view screen and secure in the full open position.
With the view screen in the full open position,
personnel protection is compromised and a
! CAUTION full faced HEPA filtered respirator must be worn.
Note: Depending on the model, the diffuser screen is secured to the cabinet by #8-32 screws or 1/4" - 20 acorn
nuts, 3 places. It is purposely a tight fit and is secured to the back wall with projecting threadless studs.
e. Clean both sides of the perforated metal diffuser screen and remove it from the cabinet.
f. Lift the cabinet work tray, clean both sides and remove it from the cabinet.
g. Remove the front perforated grill, place on the cabinet floor and clean both sides. Remove from cabinet.
h. Clean work tray supports.
i. Working from top to bottom, clean all inside surfaces of the cabinet. Take care not to wet the HEPA filter.
If liquid has collected in the plenum drain, aspirate it using IV tubing into an evacuated container. Label
the evacuated container for disposal as chemotherapy waste.
j. Clean the plenum drain area and wipe dry.
k. If the cabinet requires maintenance and/or replacement of the HEPA filters, the operation should be
halted at this point to allow trained personnel to complete replacement of the HEPA and/or maintenance
action required.
6.6.3 Assembly
a. Replace front (if removed) grill.
b. Replace the work tray and carefully tighten the thumbscrews.
c. Replace perforated metal diffuser screen over the underside of the supply HEPA filter.
d. Wipe down all exposed surfaces of the work area with 70% isopropyl alcohol.
e. Prepare for aseptic operation.
¹ Available from Lab Safety Supply, Janesville, WI 53547-1368, or other laboratory, industrial, or hospital supply distributors.
²American Society of Hospital Pharmacists. 1990. ASHP Guidelines on Handling Cytotoxic and Hazardous Drugs Am. J. Hosp. Pharm. 47:1033-49
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7.0 General Maintenance
7.1 Decontamination
No maintenance should be performed on the interior of the CELLGARD ES cabinet (area behind access panels) unless the
cabinet has been microbiologically decontaminated, is known to biologically clean, or known to be chemically inert. Surface
disinfection is performed as specified in the Cleaning Procedures section.
This procedure presents considerable risks and must be performed only by specially trained
and authorized service personnel in accordance with applicable national safety regulations
(e.g. Germany: TRGS 522).
The formaldehyde is vaporized within the tightly sealed sample chamber. The quantity of the
applied formaldehyde depends on the volume of the sample chamber in the safety cabinet that
is to be disinfected. The formaldehyde evaporates immediately after reaching its boiling point;
the minimum reaction time is 6 hours. Therefore, the formaldehyde should be neutralized after
the specified reaction time by vaporizing ammonia.
Flammable Hazard!
! CAUTION
Formalin in reaction with hydrogen chloride will form BCME which is a hazardous chemical.
When using formalin, all residues of hydrogen chloride in the work chamber of the cabinet must be
removed.
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2. Remove the front decorative panel via top/front fasteners.
3. Remove left and right window farings via upper, middle, and top fasteners.
At this point, the sliding window can be removed or allowed to hang from its top position.
If the window is allowed to hang, use duct tap to secure to the cabinet during the remaining process.
4. Remove armrest via fasteners.
5. Remove downflow and exhaust probe shrouds. Remove only the downflow probe by turning the locking ring
counter clockwise.
6. Remove the diffuser screen and window wiper seal.
7. Place decontamination equipment inside the work area. Reference decontamination procedure,
per EN 12469, Annex J, using the following chart to calculate chemical requirements.
Note: The outlets in the work area are energized as long as the cabinet is plugged in and switched on the front panel.
Unplug the cabinet before decontamination equipment is plugged into these outlets.
The control centers electrical connectors may be re-attached to utilize the cabinet's interior outlets and fan
during the decontamination. (See step 8)
8. Set control center on its side (with the ballast end down and the blower capacitor end up) on the left side of
cabinet. Then plug in the 16-pin connector cable from the cabinet to the control center.
In order to activate the blower, a jumper wire must be used to bridge the B/UVT and B/UV - contacts on the main
board. Reconnect power to the cabinet. The outlets and blower can then be activated.
9. Seal front and top openings using pressure plates.
a. The front plate is attached using the following steps:
1) Remove screws in SST header just above workzone opening.
2) Place front seal plate over bottom row of studs with the plate gasket next to the work access
opening and the remaining holes should line up.*
3) Fasten the plate using the fastening screws and nuts provided.
b. The top seal plate is attached using the following steps:
1) Remove filter guard above exhaust HEPA filter.
2) Remove exhaust sensor shroud via fasteners.
3) Place top seal plate over the studs and attach fastening nuts provided.
Note: *Electrical
Front and top seal plates are obtained by contacting NuAire Representative or Distributor
service can be provided to the inside of the cabinet via the electrical bulkheads
on the front pressure plate. Access to the neutralizing plate can be obtained through the
liquid tight fitting on the front pressure plate.
Normally, no preventive maintenance is required on the interior of the cabinet (i.e., the area behind the access panel
containing the HEPA filters and motor (blower assembly). All required adjustments in order to maintain proper cabinet
airflows are external to the cabinet interior. The motor is lubricated for life and is thermally protected with automatic
reset.
¹ Available from Lab Safety Supply, Janesville, WI 53547-1368, or other laboratory, industrial, or hospital supply distributor
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7.2 Fluorescent Lamp, Bulb Replacement
The two (T8) fluorescent bulbs are cool white, rapid start and placed external to the cabinet to aid maintenance and
minimize heat build-up within the cabinet. The life rating of the bulb is 9000 hours based on three hour burning cycles.
The HEPA Filters should not be replaced until the entire cabinet has been decontaminated or known to be biologically
"clean".
Step 1: Remove screws at each upper side of the control center and allow the control center to rotate down,
resting on the safety straps. Second, remove the front decorative panel, which is held into position
by (3) knurled nuts on the top edge and snap fit bullet catches on the bottom.
Step 2: Place sliding window into lowest position and remove front filter panel, which is held into position by
Phillip pan head screws. Once the screws are removed, the panel is held into position by smooth
weldstuds located on the top corner of the front filter panel. Use the window stop brackets as handles to
remove the panel.
The interior of the cabinet is now fully exposed for replacement of the filters and/or motor/blower.
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Step 3: Filter Removal
It is not always necessary to replace both the supply and exhaust filters at the same time. If during the
course of certifications, the downflow falls off while the exhaust increases the supply filter is "loading"
faster than the exhaust filter and only the supply filter may need replacement. The opposite might also
happen depending upon many factors.
a. To remove the supply filter:
1. Unscrew the 3 hand knobs (about 3 turns away from filter) located behind the supply
HEPA filter. This will relieve the pressure to the rear of the plenum.
2. Relax the 4 plenum screws in front of the supply HEPA filter.
3. Lift the permanent plenum and hold up with wire strap.
4. Carefully remove the supply filter. Direct exposure should be avoided.
CAUTION: Dispose of spent HEPA filters properly.
Avoid direct contact to "dirty side" of the filters. Label toxic waste.
b. To remove the Exhaust HEPA:
1. Relax the exhaust filter seal loading mechanism by turning the four threaded bolts
counterclockwise until one can see a definite release of the loading springs.
2. Pull the exhaust choke tray free and remove the filter. It is not necessary to remove the
tray, although it is free to move forward several inches, if necessary, to free the HEPA filter.
Step 4: Filter Installation
When installing new filters, USE ONLY NUAIRE SPECFIED FILTERS FOR REPLACEMENT.
(Filters shall conform to EN13091 and EN 1822-1 Class H14)
NU-477-300E
NuAire Part Number: A-980962-01 A-980962-05
Filter Size: 21" (533mm) x 32" (813mm) x 3" (76mm) 20" (508mm) x 14" (366mm) x 11 1/2" (292mm)
Filter Manufacturer: Camfil Farr Camfil Farr
NU-477-400E
NuAire Part Number: A-980962-02 A-980962-06
Filter Size: 21" (533mm) x 44" (1118mm) x 3" (76mm) 20" (508mm) x 20” (508mm) x 11 1/2" (292mm)
Filter Manufacturer: Camfil Farr Camfil Farr
NU-477-500E
NuAire Part Number: A-980962-03 A-980962-07
Filter Size: 21" (533mm) x 56" (1422mm) x 3" (76mm) 20" (508mm) x 26" (660mm) x 11 1/2" (292mm)
Filter Manufacturer: Camfil Farr Camfil Farr
NU-477-600E
NuAire Part Number: A-980962-04 A-980962-08
Filter Size: 21" (533mm) x 68" (1727mm) x 3" (76mm) 20" (508mm) x 32" (813mm) x 11 1/2" (292mm)
Filter Manufacturer: Camfil Farr Camfil Farr
a. To install the supply filter, simply reverse the procedure outlines in Step 3a, above.
Note: Be sure to open the choke plate fully before inserting the filter into the tray. This will assist in adjusting the airflow.
b. To install the exhaust filter, apply a thin layer of silicone grease to the top and bottom gaskets of
the filter and carefully insert into the exhaust choke tray.
Position the filter frame within the outside walls of the exhaust opening On the top of the hood.
Tighten the spring loaded bolts, 4 places, depressing the gasket material by 1/8 inch (3mm).
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Step 5: Motor/Blower Assembly Removal
a. It is recommended that the motor/blower to be removed as a single unit. To remove, disconnect
electrical connections to the motor, remove the HEPEX pressure plenum and unbolt the
motor/blower assembly from the roof of the cabinet (4 places). Always inspect the rubber
isolation motor mounts and replace those that are cracked or visibly show stress.
b. Replace the motor exactly as originally installed in the blower housing, paying particular
attention to the correct electrical connections (see Electrical Schematic).
c. Re-install the new motor/blower assembly.
The PWM signal adjustment establishes the motor speed controls curve starting point of the programmed internal
reference performance curve while the choke adjusts or balances the exhaust airflow as well as makes up for filter
resistance tolerances. Since it has been NuAire's experience that the filters may not "load" evenly, choke adjustments may
be necessary for proper cabinet performance.
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Stored Curve versus Fixed Duty Cycle Running Mode
Normally for the NU-477 application, a stored motor loading curve is used for each size of cabinet established by setting
manual jumpers on the main control board (as referred to on the Electrical Schematic). A fixed duty cycle is also available
for special application cabinets where the stored motor loading curve performance doesn’t meet the special application
cabinet requirements,
The stored curve versus fixed duty cycle running mode can be accessed through the following designated key stroke
sequence.
Press and hold the ALARM SILENCE key
Press OUTLET ON, OUTLET OFF and release the ALARM SILENCE key. (If the sequence is properly entered, either
the fluorescent light LED would blink for stored curve running or UV LED would blink for fixed duty cycle running.
Pressing either key will change modes.)
Press the ALARM SILENCE key to enter the desired running mode. The calibration process and key strokes are the
same for both modes.
DC ECM motor PWM signal DC voltage should also be monitored and recorded upon final calibration. The DC voltage may
be measured using a digital voltmeter. The two test points to measure DC ECM motor voltage are located on the DC motor
connector on the main control board.
The cabinet is considered to be certifiable if the following airflow measurements are present:
a. Downflow average: 60 LFPM 5 LFPM (.30 m/s .025 m/s).
b. Inflow average: 105 LFPM 5 LFPM (.53 m/s .025 m/s) using the direct inflow measurement method
or constricted 3 inch (76mm) high access opening measurement method.
The airflow calibration mode is accessed through the following designated key stroke sequence.
Press and hold the alarm silence key
Press light on, light off and release the alarm silence key
(If the sequence is properly entered, the outlet LED will blink at 1 second intervals and the blower will turn on.)
Once in airflow calibration mode the PWM signal/DC voltage can be increased (increase airflow) by pressing the UV light
key. The PWM signal can also be lowered (decrease airflow) by pressing the FL light on key. During the process of pressing
these keys the associated LED will indicate a change is being made. When a minimum or maximum PWM signal/DC voltage
is reached the associated LED will remain lit indicating that no further adjustment in that direction is possible.
Note: Once at the desired airflow setting (after the last increase or decrease key change), the cabinet must run an
additional 60 seconds at this airflow setting for the system to gather averaging data before exiting the calibration
mode that enters the calibration setpoint into the system.
Note: It is possible to return the PWM signal to its original default setting. While in airflow calibration mode press
and hold both FL light on and FL light off keys simultaneously for 3 seconds, an audible alarm will beep on each of
the 3 seconds. Upon completion of the process, both the FL light on and UV light LED’s will blink 3 times indicating a
successful reset has occurred.
Once the airflow calibration is complete; exit the airflow calibration mode by pressing the alarm silence key.
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7.5.1 Downflow Calibration
Step 1: Place a velometer in the cabinet workzone on the horizontal plane 4 inches (102mm) above the
bottom edge of the viewing window. Spot check several points on the recommended downflow
velocity test grid found in table 7.0.
Step 2: If necessary, enter the airflow calibration mode, as stated above and adjust the PWM signal/DC
voltage to achieve desired airflow.
Step 3: Proceed to inflow calibration.
Note: The choke plate adjustment requires a standard blade screwdriver. To adjust, loosen the liquid-
tight fitting around the choke adjustment shaft. While monitoring the exhaust flow to check
position, turning the choke adjustment shaft clockwise will open the choke while turning
counter clockwise closes the choke.
Step 2: Once exhaust adjustment is complete, return the downflow calibration and then check average
downflow velocity. If the downflow average remains within the correct range, the calibration is
complete. If not, readjust as necessary to obtain the correct calibration range. Once entire
cabinet has been balanced, tighten liquid-tight fastener around choke adjustment shaft.
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7.5.3 Flow Gard Calibration
Password
To enter into calibration mode, a 5 keystroke code must be entered.
Press the [] [] [RESET] [] [] in sequence.
The keypad will stay unlocked until the same 5 keystroke code is entered again.
A single audible beep will confirm the 5 keystroke code sequence was entered correctly.
To calibrate the Flow Gard monitor, the cabinet must first be certified or set to nominal airflow values.
Once the cabinet nominal airflows are set, perform the following procedure:
Press and hold the [RESET] key for 10 seconds until the display indicates "CAL".
Press the [RESET] key again. Display should indicate ".53" and "PGM".
Press the [] or [] key to match the actual calculated inflow velocity.
Press the [RESET] key to enter the calibration sequence. The monitor will perform the following sequence:
1) 2 short beeps
2) 20 second averaging countdown
3) 2 short beeps, end of sequence
4) Display will indicate "CAL" if successful or "Err" if not successful.
If the calibration is successful, press and hold the [RESET] key for 2 seconds, the display should indicate normal
readings.
If the calibration is not successful, press the [RESET] key to acknowledge the error and re-enter the "CAL"
mode. Below, is the calibration error code, along with the cause and correction. Once reviewed, try to
recalibrate using the above sequence.
Alarm limits are set at the factory to the following specifications.
1. Supply air high velocity limit shall alarm before any airflow reading is 20% above the average
velocity.
2. Supply air low velocity limit shall alarm before any airflow reading is 20% below the average
velocity.
3. Alarm shall also activate before the corrected inflow velocity is 90 fpm (.46m/s) or lower
The incorrect values will not be stored in memory. The monitor will continue to use the previous calibration values
until a correct calibration is successfully completed.
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7.5.3.2 Alarm Setpoint Calibration
If desired, the Flow Gard high or low alarm limit may be adjusted. During the calibration mode, perform the
following sequence:
Press and hold either [] or [] key for 5 seconds, display will indicate "PGM" and the current high
or low alarm setpoint.
Using the [] or [] keys, adjust to the desired alarm limit value.
Press the [RESET] key to enter the new alarm setpoint value. Monitor will give 2 quick beeps to
acknowledge the saved value and return to run mode.
Configuration Parameters
The following table shows the factory default settings for the monitor's various programmable parameters.
A default reset restores these settings.
To exit the Configuration menu, press and hold the Test/Reset button for two seconds. The monitor will also
time out and exit the Parameter Configuration menu after one minute without keypad activity.
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P01 Digits Enabled/Disabled
Digits can be enabled or disabled by entering this configuration. The PGM descriptor will turn on and by pressing either
the Up or Down button toggles between the two settings. The status indicators and icons will not be turned off. After
selection, press Test/Reset button to save. Monitor will give 2 quick beeps to acknowledge save and return to the P01
Configuration menu. Advance to another configuration or exit by holding Test/Reset button for 2 seconds.
After entering this Configuration Parameter, the time can be set to any value from 0-255. If set at 255 and alarm
temporarily silenced by pressing the Test/Reset Button, the alarm will not come on again until this alarm condition clears
and another alarm event occurs. If it is desired to not be able to silence the alarm, set to 0. Any value between 0-255
indicates in minutes the time in which the horn will alarm again if the alarm condition is not corrected. Make any changes
and press Test/Reset Button. Monitor will give two quick beeps to acknowledge save and go back to Configuration Menu.
This Configuration Parameter sets the warning-to-alarm transition timer. After this configuration menu selection is
entered, the monitor will turn on the program mode PGM descriptor and display the current value for the warning-to-alarm
transition timer. This timer can be set from 0 to 255 seconds.
When desired setting is displayed, press Test/Reset Button. The horn will give two quick beeps to acknowledge save and
return to the Configuration Menu.
This Configuration Parameter sets the alarm-to-warning transition timer. After this configuration menu selection is
entered, the monitor will turn on the program mode PGM descriptor and display the current value for the alarm-to-warning
transition timer. This timer can be set from 0 to 255 seconds. Once the desired setting is displayed, press the Test/Reset
button. The horn will give two quick beeps to acknowledge save and return to the Configuration Menu.
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P06 Low Alarm Warning Offset
The low warning offset defines the starting point of the low warning zone. It is a value (in the current unit of measure)
that is added to the low alarm setpoint. It determines when the yellow low warning light comes on.
Example: If the low alarm is set at 700 fpm and the low alarm warning offset is set at 50 fpm, the yellow low
warning light will come on at 750 fpm.
This Configuration Parameter sets the low alarm warning offset. After this configuration menu selection is entered, the
monitor will turn on the program mode PGM descriptor and display the current value for the low alarm warning offset.
When the desired setting is displayed, press the Test/Reset button. The horn will give two quick beeps to acknowledge
save and return to the Configuration menu.
P07
P08
P09 None of these are in use
P10 at this time.
P11
P12
Press the Test/Reset button. The PGM descriptor will flash once and the horn will give two quick beeps to acknowledge
that the configuration settings have been set to their factory default settings.
The monitor will return to the dEF Configuration menu selection. Press the Up and Down buttons to advance to another
Configuration Parameter. Press and hold the Test/Reset button for 2 seconds to exit the Configuration menu.
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7.6.2 Exhaust Filter
The exhaust filter is typically more difficult to check since protective grills, charcoal filters, or exhaust transitions
could cover the filter. Access panels are usually provided and should be removed. If an air gap exhaust transition
is provided, the air gap must be sealed with duct tape or other suitable means to prevent contaminated air from
migrating into the exhaust efflux. All exhaust blowers/fans should be turned off during the check.
NOTE: if the upstream challenge port is deemed contaminated and not accessible, use both downflow and exhaust
volume for determining challenge concentrations. Use following area information below with average downflow
velocity and spot-check exhaust velocities as measured to determine volume (CFM) (CMH).
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7.8 Cleanliness Classification Test for Pharmacy Application
1
If this cabinet is going to be used within pharmacy, per USP797 , the cabinet must be tested to assure compliance to ISO
2
14644-1:1999, Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness . The
cleanliness classification test is performed using a particle counter to measure particle counts within the cabinet workzone.
Turn on cabinet and let warm up for several minutes. Turn on particle counter and flush out sample tubing line to remove
latent particles. Set the particle counter to measure 0.5 micron or larger particles at the appropriate measuring rate.
3
“Operational Particle Count Test ”
Position the particle counter isokinetic probe at a point 6 inches (152mm) upstream of the aseptic manipulation area (hand
convergence point) and mounted so as not to interfere with the operator’s hand movement. The pharmacy operator will
simulate IV manipulation during the particle count test using non-hazardous materials. A minimum of three (3) 1-minute
particle counts shall be sampled and recorded while the user simulates aseptic compounding manipulations.
Record the 5 particle count values for each of the test points over the 1-minute sample time. All final count particle
concentrations and calculated 95% upper confidence limit shall not exceed 3520 particles per cubic meter (ppcm) or (100
particles per cubic feet (ppcf).
1
USP28-NF23: United Stated Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD
20852, USA, www.usp.org.
2
ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments-Classification of Air Cleanliness, International
Organization for Standardization, Case Postale 56, CH-1211 Geneve 20, Switzerland
3
CAG-002-2006: CETA Compounding Isolator Testing Guide, Controlled Environment Testing Association, 1500 Sunday
Drive, Suite 102, Raleigh, NC 27607, USA, www.cetainternational.org
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Table 7.0
Recommended Measurement Methods for Cabinet Downflow & Inflow
A. Downflow Measurement
a. Recommended Instruments: TSI 8355 Thermoanemometer
b. Procedure:
Supply filter efflux is measured on a grid, in a horizontal plane 4 inches (102mm) above the bottom edge of the
window. No reading should be taken closer than 6 inches (152mm) from the inside perimeter.
c. Test Data - Inches (mm):
d. Acceptance Criteria:
1. Average downflow velocity = 55 to 65 fpm (.28 to .33 m/s)
2. Individual readings must be within +20 percent of the average downflow velocity.
B. Inflow Measurement
a. Recommended Instrument: Shortridge Flowhood ADM-870 or TSI 8355 Thermoanemometer.
b. Primary Procedure:
The primary procedure to determine inflow velocity uses a Direct Inflow Measurement (DIM) Instrument (i.e.
Shortridge Flowhood). The DIM Instrument can be used directly on the cabinet with NO CORRECTION FACTORS
REQUIRED if operated in the local density default mode. NSF has tested the cabinet and established listed air
velocities expressed in local density. The DIM Instrument should be equipped with a flowhood that is as close as
possible to the width of the cabinet (i.e. NU-477-400 should use 1 x 4 foot flowhood). The DIM Instrument should
also be duct taped to the cabinet to prevent any sneak air paths from occurring.
The DIM Instrument will read inflow volume (i.e. CFM). Use the window access opening area to calculate inflow
velocity.
Alternate Procedure:
The alternative procedure to determine inflow velocity uses a thermoanemometer in a constricted window access
opening of 3 inches (76mm) with the armrest removed. Inflow air velocity is measured in the center of the
constricted opening 1-1/2 inches (38mm) above the work access opening on the following specified grid. Use the
correction factor table to calculate the inflow velocity.
3 3 2 2
Inflow Volume t. /min.(m /s) Access Opening ft. (m ) Inflow Velocity ft./min(m/s)
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2. Constricted 3 inch (76mm) high access opening measurement - Inches (mm):
2 2 3
Average Velocity fpm (mps) X Constricted Area ft (m ) = Constricted CFM (m /s)
of Constricted Area Area Volume
Average Velocity of 8" (203mm) fpm (mps) X Correction Factor =Average Inflow Velocity fpm (mps)
Access Window Area
d. Acceptance Criteria:
1. Access Opening Inflow Velocity = 100 to 110 fpm (.51 to .56 m/s)
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7.10Main Control Board Description & Replacement
The main control board consists of one Printed Circuit Board (PCB) assembly. The assembly consists of a power supply,
relay logic and an independent motor speed control.
Disconnect electrical power from the unit before attempting any maintenance action.
The main control board is fastened to the control center with (6) 6-32 studs, lockwashers and nuts. All electrical
connections are made with removable terminals and/or Faston connectors. All AC circuits are fuse protected and when
replacement is necessary, USE ONLY FUSES OF SAME TYPE AND RATING FOR PROTECTION AGAINST RISK OF FIRE.
The main control board has several configuration jumpers used for different purposes. J1, J2, and J3 are used for the
blower password and night setback mode selection/configuration. J4 and J9 are not used for this application and J6 & J7
are used to configure the ECM motor curve for the appropriate size of cabinet (see chart below).
The DC ECM motor PWM signal/DC voltage can be measured and monitored. The DC voltage may be measured using a
digital velometer. The two test points to measure the PWM signal/CD voltage are located on the DC motor connector on
the main control board. PWM signal/DC voltage will range between 2.5 and 8.0 Vdc during normal operation and
approximately 2.0 Vdc during night setback mode.
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8.0 Error Indicators & Troubleshooting
Audible alarms and error indicators occur for a variety of reasons. Whenever an alarm condition is present, the audible
alarm and error indicator will be presented and stay on until the error is cleared. When presented with an error indicator,
please perform the following:
Step 1: NOTE ALL ERROR INDICATORS.
When the cabinet is running, any and all red indicators display an error.
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9.0 Remote Contacts
Ultraviolet light will injure your eyes. Avoid direct viewing at all times.
! CAUTION Personnel should not be present when ultraviolet lamp is on.
10.1.1 Overview
The germicidal ultraviolet is primarily intended for the destruction of bacteria and other microorganisms in the air
or on directly exposed surfaces. Approximately 95% of the ultraviolet radiation's from germicidal tubes are in the
253.7 nanometer region. This is a region in the ultraviolet spectrum which is near the peak of germicidal
effectiveness. The exposure necessary to kill bacteria is the product of time and intensity. High intensities for a
short period of time, or low intensities for a longer period are fundamentally equal in lethal dosage on bacteria
(disregarding the life cycle of bacteria). The intensity of light falling on a given area is governed by the inverse law;
that is the killing intensity decreases as the distance increases from the tube.
The germicidal tube is placed in the cabinet to provide an average intensity of 100 microwatts per centimeter
(for a new tube) falling on a horizontal plane defined by the bottom of the work surface. The minimum
requirement per paragraph 5.12 of NSF Standard 49 is 40 microwatts per square centimeter (ref. NSF Std. #49,
June, 1976).
Since ultraviolet rays will not penetrate ordinary glass, it is recommended that the sliding window be closed while
the ultraviolet light is on within the cabinet; or that personnel leave the cabinet face area.
10.1.2 Operation
The operation of the ultraviolet lamp is accomplished by closing the sliding window and pressing the UV switch
located on the front panel.
10.1.3 Precaution
The rays from germicidal tubes may cause a painful but temporary irritation of the eyes and reddening of the skin,
if of sufficiently high intensity, or if exposure covers a prolonged period of time. For this reason, one should avoid
direct eye and skin exposure to ultraviolet light. If exposure cannot be avoided, it is necessary for personnel to
wear eye goggles or face shields, and long sleeve gowns with rubber gloves.
Since ultraviolet rays will not penetrate ordinary glass, it is recommended that the sliding window be closed while
the ultraviolet light is on within the cabinet; or that personnel leave the cabinet face area.
10.1.4 Maintenance
The output of an ultraviolet lamp deteriorates with burning age. The useful life of the lamp is approximately 7000
hours under specific test conditions.
Note: Before testing with lamp off, the light may be cleaned with a lint-free cloth dampened with
alcohol or ammonia and water
It is recommended that either a time schedule is established or the tube's output is measured periodically and the
tube replaced when its output falls below 40 microwatts per square centimeter or exceeds 7000 hours of
operation. Lamps should be allowed to operate approximately 5 to 10 minutes (longer when the lamp is in low
temperatures) to warm up sufficiently and wiped clean of dust or dirt before reading the output with a meter.
Even minute amounts of dust will absorb ultraviolet energy.
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Energies Required to Destroy Some Microorganisms by Ultraviolet Radiations(e)
Microwatt Microwatt
Mold Spores seconds Protozoa seconds
per cm/2 per cm/2
Penicillum roqueforti 26,400 Paramecium 200,000(a)
Penicillium expansum 22,000
Penicillium digitiatum 88,000 Nematode Eggs 40,000(b)
Aspergillus glaucus 88,000
Aspergillus flavus 99,000 Algae 22,000(c)
Aspergillus niger 330,000
Rhizopus nigricans 220,000 Virus
Mucor racemosus A 35,200 Baceriophage (E. Coli) 6,600
Mucor racemosus B 35,200 Tobacco Masaic 440,000
Oospora lactis 11,000 Influenze 3,400(d)
Yeasts
Saccharomyces 13,200
ellipsoideus 17,600
Saccharomyces cerevisiae 13,200
Brewers' yeast 6,600
Baker's yeast 8,800
Common yeast cake 13,200
Bacteria
Streptococcus lactis 8,800
Strep. hermolyticus (alpha type) 5,500
Staphylococcus aureus 6,600
Staphylococcus albus 5,720
Micrococcus sphaeroides 15,400
Sarcina lutea 26,400
Pseudomonas fluorescens 7,040
Escherichia coli 7,040
Proteus vulgaris 7,480
Serratia marcescens 6,160
Bacillus subtilis 11,000
Bacillus subtilis spores 22,000
Spirillum rubrum 6,160
References:
(a) Luckiesh, Matthew (1946) Application of Germicidal, Ethyemal and Infrared Energy, D. Van Nostrand o., New York, New York,
pp 253
(b) Hollaender (1942) Aerobiology, A.A.A.S. (for 90% inactivation), pp 162
(c) Ellis, C. and Wells, O.O. (1941) The Chemical Action of Ultraviolet Rays, Reinhold Publishing Corp., pp. 713-714
(d) Hollaender, A., Oliphant, J.W. (1944) The inactivation effect of monochromatic ultraviolet. Radiation on Influenze Virus (for
90% inactivation) Jour. of Bact. 48, pp. 447-454
(e) This table, "Energies Required to Destroy Some Microorganisms by Ultraviolet Radiations" comes from Westinghouse brochure
entitled - "Westinghouse Sterilamp Germicidal Ultraviolet Tubes"
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11.0 Electrical/Environmental Requirements
*CE Certified
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12.0 Disposal and Recycle
Cabinets that are no longer in use and are ready for disposal contain reusable materials. ALL components with the
exception of the HEPA filters may be disposed and/or recycled after they are known to be properly disinfected.
Note: Follow all local, state and federal guidelines for disposal of HEPA filter solid waste.
BIOHAZARD
Component Material
Base Cabinet Stainless Steel
Front Grill Stainless Steel
Worksurface Stainless Steel
Window Faring Stainless Steel
Window Glides HDPE
Window Safety Glass
Window Frame Stainless Steel
Front Service Panel Painted Steel
Front Decorative Panel Painted Steel
Control Center Painted Steel
Supply Diffuser Aluminum
Exhaust Filter Aluminum
HEPA Filter Frames Painted Steel
Hepex Bag PVC
Blower Wheel & Housing Steel
Motor Various Steel/Copper
Printed Wiring Assembly Lead Free Electronic
Wire PVC Coated Copper
Ballasts Various Steel, Electronic
Armrest PVC
Connectors Nylon
Hardware Stainless Steel and Steel
Note: Material type can be verified with use of a magnet with stainless and aluminum being non-magnetic.
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