O&M Manual for NuAire NU-201 Table Top Horizontal

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AIREGARD ES Energy Saver Horizontal Laminar Flow
Clean Workstation
Model NU-201/E
Bench Top Model
Operation and Maintenance Manual
October, 2012
Revision 2
Series 60
(115VAC 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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AIREGARD ES Energy Saver Horizontal Laminar Flow
Clean Workstation
Model NU-201/E
Bench Top Model
Operation and 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 ...................................................................................... Certification Testing Methods and Equipment
Section No. 6.............................................................................. Operating the Laminar Flow Clean Workstation
6.1 ...................................................................................... Operator Controls & Indicators
6.2 ...................................................................................... Operating Guidelines
6.3 ...................................................................................... Ergonomics
6.4 ...................................................................................... Cleaning Procedures
Section No. 7.............................................................................. General Maintenance
7.1 ...................................................................................... Fluorescent Lamp Bulb Replacement
7.2 ...................................................................................... HEPA Filter Replacement
7.3 ...................................................................................... Prefilter Replacement
Section No. 8.................................................................................... Polycarbonate Material Compatibility
Section No. 9.................................................................................... Error Indicators and Troubleshooting
Section No. 10............................................................................ Optional Equipment
10.1 .................................................................................... Ultraviolet Lamp
Section No. 11.................................................................................. Electrical/Environmental Requirements
Section No. 12............................................................................ Disposal and Recycle
Insert .......................................................................................... Replacement Parts List
Manual Drawings
BCD-06900..........................................................Specification Drawing NU-201/E
Assembly Drawings
ACD-06899..........................................................Blower Brace Removal
BCD-06989..........................................................Base Stand Assembly
BCD-06901..........................................................HEPA Filter Replacement
Electrical Schematics
BCD-14941..........................................................Electrical Schematic 115V
BCD-14942..........................................................Electrical Schematic 230V
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AIREGARD ES Energy Saver Horizontal Laminar Flow
Clean Workstation
Models NU-201/E
Manufactured By:
NuAire, Inc.,
Plymouth, Minnesota
1.0
General Description
NuAire AIREGARD Horizontal Laminar Flow Clean Workstations utilize the newest technologies in laminar airflow design,
materials and manufacturing processes. The clean workstation can be used where clean airflow per ISO 14644-1 is required for the
preparation of injectable drugs, IV solutions, tissue culture, optics, microelectronics, etc. The clean bench should not be used for any
work that involves biological agents assigned a level of Risk 1 through 4 as classified by the Centers for Disease Control (CDC),
Atlanta, Georgia, since the horizontal flow offers no personnel protection against these agents. The clean bench should only be used
to protect the product from contamination. The clean bench is optionally available with a base stand, placing the work surface at
30” (762mm) or 36” (914mm). A significant number of design innovations give the NuAire Laminar flow equipment superior
performance qualities in airflow, lighting, noise levels and vibration.
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1.1 Safety Instructions
These safety instructions describe the safety features of the AIREGARD Horizontal Laminar Flow Clean Workstation model
NU-201/E. The workstation has been manufactured using the latest technological developments and has been thoroughly
tested before delivery. It may, however, present potential hazards if it is not used according to the intended purpose or
outside of operating parameters. Therefore, the following procedures must always be observed:
• The workstation must be operated only by trained and authorized personnel.
• For any operation of this unit, the operator must prepare clear and concise written instructions for operating and
cleaning, utilizing applicable safety data sheets, plant hygiene guidelines, and technical regulations, in particular.
o which decontamination measures are to be applied for the workstation and accessories,
o which protective measures apply while specific agents are used,
o which measures are to be taken in the case of an accident.
• Repairs to the device must be carried out only by trained and authorized expert personnel.
• Keep these operating instructions close to the unit so that safety instructions and important information are
always accessible.
• Should you encounter problems that are not detailed adequately in the operating instructions, please contact your
NuAire Representative of NuAire technical Services.
1.2 Explanation of Symbols
! WARNING
!
CAUTION
CAUTION:
Safety alert symbol indicates a potentially hazardous
situation which, if not avoided, could result in death
of serious injury.
Safety alert symbol indicates a potentially hazardous
situation which, if not avoided, may result in minor or
moderate injury.
CAUTION used without the safety alert symbol
indicates a potentially hazardous situation which, if
not avoided, may result in property damage.
Potential electrical hazard, only qualified person
to access.

NOTE:
Used for important information.
Flammable Hazard
Biohazard
Hazardous Gases! Personal
Protection Equipment Required.
Ground, Earth
Chemical Hazard
Lead Free
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2.0
Models and Features
NuAire's Model Number NU-201/E designates the basic design series of AIREGARD Horizontal Laminar Flow Clean
Workstation with the blower/motor located above the work surface (i.e. bench series). Model numbers are shown below.
Model Number
NU-201-224
NU-201-230
NU-201-230E
NU-201-324
NU-201-330
NU-201-330E
NU-201-336
NU-201-424
NU-201-430
NU-201-430E
NU-201-436
NU-201-524
NU-201-530
NU-201-530E
NU-201-536
NU-201-624
NU-201-630
NU-201-630E
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3.0
Warranty
NuAire, Inc. warrants Horizontal Laminar Flow Clean Workstation w/ECM motor (AIREGARD 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, Inc. 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 insure that your AIREGARD Clean Workstation 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 AIREGARD Clean Workstation to
be sure that if damage has occurred, the proper claims and actions are taken immediately.
4.1 Damaged Shipments
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, production area, etc., the ideal location for the clean workstation is away from personnel
traffic lanes, air vents (in or out), doors and/or other source of disruptive air currents. If drafts or other disruptive air
currents exceed the face velocity of the HEPA filter, the potential exists for contaminated air to enter the work area of the
workstation. Please note, however, that the work area has been constructed to minimize the effect of air currents by
providing sidewalls that are an extension of the HEPA filter flow area.
Where space permits, a clean six (6) inch (152mm) area should be permitted on each side of the workstation for
maintenance purposes. The electrical outlet into which the workstation is connected should be readily accessible.
The workstation shall be positioned as not to obstruct the power supply outlet or the circuit breaker distribution panel.
5.2 Set-Up Instructions
Remove outer shipping protection (carton or crating). If the workstation is fastened to a base skid, it is usually the best
procedure to leave the skid in place until the workstation is located in its approximate position to facilitate ease in handling.
It can then be removed from the skid by removing the four bolts holding the workstation to the skid.
5.2.1
Motor Shipping Bracket
The motor is securely fastened to the workstation during shipment to prevent damage to the blower housing
mounting brackets. The procedure for removing the motor shipping bracket is shown in Drawing ACD-06899.
5.2.2
Base Stand Assembly
The base stand is shipped K.D. in a separate carton and is assembled per Drawing BCD-06989 if accompanied with
the unit. With a forklift or other suitable lifting device, lift the NU-201/E between the top of the skid and the
bottom of the workstation, slightly off of the floor and remove the four bolts holding the skid to the workstation
(one in each corner). Now lift the workstation on top of the base and bolt the base stand to the workstation using
four 1/2" (13mm) - 13” (330mm) x 3" (76mm) bolts and washers provided in the same holes as the skid was
fastened. Place the workstation in its desired location.
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5.2.3
Gas Service
NuAire doesn't recommend the use of natural gas within the clean bench, but if gas service is determined to be
necessary for the application by the appropriate safety personnel, appropriate safety measures must take place.
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.
!
CAUTION
IT IS ALSO STRONGLY RECOMMENDED THAT AN
EMERGENCY GAS SHUTOFF VALVE BE PLACED JUST
OUTSIDE THE CLEAN BENCH ON THE GAS SUPPLY LINE.
All NuAire clean benches meet the safety requirements of UL and CSA for Laboratory Equipment. To comply with
these safety requirements, NuAire uses only certified gas valves. In addition, if external piping is required, only
black pipe is used for this application.
As previously stated NuAire doesn't recommend the use of natural gas within the clean bench and ASSUMES NO
RESPONSIBILITY FOR ITS USE. USE AT YOUR OWN RISK. The Bunsen burner flame within the clean bench disrupts
the laminar air stream, which must be maintained for maximum efficiency.
!
CAUTION
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.
5.2.4
Plumbing Services
Ground key cocks with the type of service specified by the snap-in button on the handle, are located in the work
zone. The ground key cocks are not recommended for pressures over 30 p.s.i. Reducing valves should be installed
external to the workstation if necessary. Ground key cocks should never be used for oxygen service. A special
needle valve for oxygen service is required and available upon request.
External connection is to 3/8 inch (10mm) FPT coupling through the 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.
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5.2.5
Electrical Services
The Horizontal Laminar Flow Clean Workstation may be "hardwired" (optional) or connected via an electrical
power cord, which is standard. The unit requires 115/230 VAC, 60/50 Hz, single phase. (Current rating varies per
workstation size, reference Electrical/Environmental Requirements). It is recommended that power to the unit be
on its own branch circuit, protected with a 15 Amp circuit breaker or fuse at the distribution panel.
 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.
If a "hardwired" (conduit) connection is desired, an electrical junction box is provided on the top of the
workstation with a removable cover. All wiring connections to the junction box should be done according to the
National Electrical Code and/or local codes by a qualified electrician.
5.2.6
Final Assembly
The exterior surfaces 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. Workstation interior walls or work surface is easily cleaned with
any mild household detergent cleaner using a soft cloth. Turn the workstation on and let it operate for 60 minutes
before using it as a clean bench.
5.3 Certification Testing Methods and Equipment
After installation and prior to use, NuAire recommends that the workstation be recertified to factory standards.
At a minimum, the following tests should be performed.
1. HEPA filter media
2. Filter frame leak test
3. Airflow velocities
The testing methods and equipment required are specified on the factory inspection report included with this manual.
 NOTE:
IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED TECHNICIAN WHO IS FAMILIAR WITH
THE METHODS AND PROCEDURES FOR CERTIFYING CLEAN BENCHES.
 NOTE:
AFTER THE INITIAL CERTIFICATION, NUAIRE RECOMMENDS THAT THE WORKSTATION BE RECERTIFIED 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 NuAire Clean Workstations, filters and seals provide premium performance; Quality control in both design
and manufacturing insure superior reliability. However, protection to the product is so important, that certification to the
performance requirements should be accomplished as stated to insure conformance to factory standards.
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6.0
Operating the Laminar Flow Clean Workstation
6.1 Operator Controls and Indicators
The following is a description of the controls and indicators provided on the NU-201 clean workstations.
6.1.1
Fluorescent/UV Light Switch
This switch provides on/off control for the fluorescent light and/or the ultraviolet (UV) light if present (optional).
With the UV light option, the switch provides for on-center off-on operation so that both the fluorescent light and
the UV light cannot be energized at the same time. Proper care should be exercised when the UV light is on.
6.1.2
Blower Switch
The blower switch applies power to the internal blower/motor when in the ON position.
6.1.3
Indicator Light - Blower
A green neon indicator light is located next to the blower on/off switch and lights when power is applied to the
motor/blower.
6.1.4
Circuit Breaker - Blower
The blower motor is protected with a circuit breaker. The circuit breaker, in conjunction with the motor's thermal
protector, is designed to open under locked rotor or half-wave power conditions. Should the circuit breaker open,
merely depress the button to reset. If the circuit breaker continually opens, a failure has occurred in the motor or
solid-state speed controller. Consult a qualified repair technician or NuAire, Inc. for replacement.
6.1.5
Airflow Control Potentiometer
The operating horizontal airflow within the workstation (80-100 LFPM (.41 to .51 m/s) is controlled by a DC motor
speed control. The DC motor speed control, controls the EC motor by providing a pulsed width modulation (PWM)
signal of 2.5 to 8.0 VDC that is sent to the EC motor. This adjustment should only be made by a qualified
technician employing the proper instruments in order to insure airflow.
6.1.6
Minihelic Gauge
The minihelic gauge displays the static pressure within the pressure plenum supplying air to the HEPA filter. The
gauge is calibrated in "inches of water gauge" pressure. As the HEPA filter loads with particulate matter, the
amount of static pressure will increase, giving an indication of the "health" of the workstation. The initial pressure
reading will be approximately 0.50" (13mm) w.g. + 0.05" (2mm) w.g depending on altitude from sea level. The
workstation should be checked for proper airflow at each 0.1-inch (2mm) increase in static pressure.
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6.2 Operating Guidelines
Operate the laminar flow workstation continuously. The unit will then remain in its initially clean condition. If, for any
reason, the unit is turned off, the face of the protective screen in horizontal airflow units should be cleaned - preferably
with a small brush. Clean the interior surfaces with lukewarm water and a mild detergent. Turn the unit on and permit to
operate for 15 minutes before resuming operations.
Allow only essential items in the work station. Objects should not be placed between the HEPEX and any point where the
clean environment must be maintained. New items introduced into the work area should be placed downstream of items
already in the work zone for several minutes to allow contaminants to flush off. Note that plastic parts may carry a static
charge which may require special handling in order to remove contaminants.
Particular care must be exercised in placing equipment within the work space. Where possible, equipment should be
placed on perforated platforms to allow air movement under as well as around the object.
All work should be performed with the operator's hand or head downstream of the critical process points. Unnecessary
movement with the work station should be kept to a minimum.
If the workstation is used in a manner not specified by NuAire, the protection provided by the equipment may be impaired.
6.2.1
Operating Sequence
A. Start Up
Turn on workstation blower and lights, check air intake ports of the workstation to make sure they are
unobstructed. The workstations are provided with gauges which indicate pressure differentials across the
filters. They indicate when to replace the filters, dependent upon the blower fan capacity. Blower speed must
only be readjusted by qualified maintenance technicians.
B.
Some workstations are equipped with ultraviolet (UV) lights. These must be turned off during the day while
laboratory personnel are occupying the room. Good procedure includes the decontamination or wipe down
of workstation 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.
C.
Allow blowers to operate for a minimum of 5 minutes before aseptic manipulations are begun in the
workstation. An additional advantage is obtained from purification (filtration) of the room air circulated
through the equipment. Because of the characteristic contributed to the quality of the laboratory
environment, some owners leave them in operation beyond the time of actual use.
D. Minimize Room Activity - Activity in the room itself should be held to a minimum. Unnecessary activity may
create disruptive air currents, as well as interfere with the work of the operator. A person walking past the
front of the workstation can cause draft velocities up to 175 FPM, which are sufficient to disrupt the air
balance of the Laminar Flow Unit.
E.
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Utilize Unidirectional Airflow - The operator must keep two important facts in mind:
1) The air, as supplied to the work area through the HEPEX is contaminant-free.
2) Airborne contamination generated in the work area is controlled by the unidirectional flow of parallel air
streams.
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 behind 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.
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6.3 Ergonomics
Ergonomics, the study or accommodation of work practices is extremely important for proper workstation usage and user
health and safety. An evaluation of normal work practices should be performed with each user when working in a
workstation. 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 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 workstation is provided with a 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.
• 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 effect workzone.
6.4 Cleaning Procedures
6.4.1
To Clean Polycarbonate Side Panels
Use a damp soft cloth with a mild soap or mild inorganic acids/bases such as sodium-hydroxide, sodiumhypochlorite or mild bleaches or 3% peroxide.
DO NOT USE ORGANIC SOLVENTS, SUCH AS ALCOHOL, KETONES,
ACETONE, TOTUOL, ETC., ON THE POLYCARBONATE - IT CAN CRAZE
THE SURFACE UNDER CERTAIN CONDITIONS OF SURFACE STRESS
AND HUMIDITY.
CAUTION
!
6.4.2
Recommendations for Cleaning Spills on the Work Surface
1. Discontinue work process if feasible and turn the blower motor off.
2. Inspect spill.
3. If contents of spill are potentially harmful, wear appropriate personnel protection equipment.
4. Remove debris from spill and wipe up liquids cautiously to prevent further contamination.
5. Broken containers and contaminated cleaning materials should be disposed of in appropriate disposal
containers (depends on type of contamination).
6. Wipe surfaces clean:
a. Apply appropriate disinfecting solution to workstation surface. Most surface disinfectants require a
specific contact time, depending upon the microbiological agents used within the workstation.
CONSULT APPROPRIATE DISINFECTANT DOCUMENTATION FOR PROPER APPLICATION AND SAFETY
PRECAUTIONS.
DISINFECTANTS THAT USE CHLORIDES AND HALOGENS WILL
CAUSE DAMAGE TO THE STAINLESS STEEL SURFACES IF LEFT ON
FOR LONG PERIODS OF TIME.
!
CAUTION
b. After the specified contact time, wipe up excess disinfectant.
IF THE DISINFECTANT USED CONTAINS CHLORIDES OR HALOGENS, RE-WIPE ALL SURFACES WITH
70% AHCOHOL OR SIMILAR NON-CORROSIVE ANTI-MICROBIL AGENT TO PREVENT DAMAGE TO
STAINLESS STEEL SURFACES
7.
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Leave the unit running for 5 to 30 minutes before continuing work to allow the system to purge itself.
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7.0 General Maintenance
CAUTION
!
All maintenance actions on this equipment must be performed by a qualified
technician who is familiar with the proper maintenance procedures required for this
equipment. This includes both certification as well as repair.
7.1 Fluorescent Lamp Bulb Replacement
The fluorescent bulbs are T8, cool white, electronic start and obscured from direct view by Plexiglas diffuser. The life rating
of a bulb is 9000 hours based on three hour burning cycles.
To replace a bulb:
1.
2.
First, switch the workstation light switch off.
Second, remove the front cover. Two knurled thumbscrews on either side of the front panel light cover. And
either one (for 3 or 4 ft. units) or two (for 5 to 6 ft. units) knurled thumbscrews below the front cover through the
Plexiglas top panel. Once removed, the bulbs are directly exposed.
The lamp bulbs are removed by rotating until the pins can be pulled down.
Reverse the procedure to reinstall the lamp assembly.
3.
4.
7.2 HEPA Filter Replacement
The HEPA filter, under normal usage and barring an accident (puncture), does not need replacement until the efflux velocity
cannot be maintained at 90 LFPM (.457 m/s) + 10%. This may permit the HEPA filter efflux average to be as low as 81 LFPM
(.411 m/s), as long as no point falls below 70 LFPM (.355 m/s). Use only replacement filters of the same rated flow and size
as originally installed to insure proper airflow and HEPA filter lifetime can be achieved.
The HEPEX system is removed as follows (see also the procedures on Drawing BCD-06901):
1.
2.
3.
4.
5.
6.
7.

NOTE:
8.
9.
Remove the prefilters.
Remove the prefilter screen by unscrewing 4 screws per screen.
Remove the front cover. Remove the 2 screws on either side of the front panel light cover.
Two knurled thumbscrews 8 in. (203mm) down inside the top of the front cover and either one (3 or 4 foot units)
or two (5 to 6 foot units) knurled thumbscrews below the front cover through the Plexiglas top panel.
Remove Clamping Strap holding HEPEX plastic plenum to Blower.
Remove the HEPA filter protective screen.
Remove the diffuser lip.
Remove the HEPEX filter by tipping the top forward -- then lifting completely out.
This step usually requires 2 people for the removal and replacement of the HEPEX.
Replace new HEPEX by proceeding through the disassembly steps backwards.
For complete confidence that the clean workstation is providing the bio-clean environment desired -- the bench
should be checked for filter integrity and airflow by a competent technician Airflow velocity should be regulated to
an average 90 FPM (.457 m/s) (via the solid state motor speed control on the blower (16); Cleanliness should meet
Federal Standard 209c, Class 10 conditions.
7.3 Pre-Filter Replacement
The replacement interval depends on the contaminant (large particles or lint) in the room -- a typical period is every 3
months. The prefilters are located on the top of the workstation.
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7.4 Airflow Calibration
The NU-201 Airflow calibration consists of airflow velocity adjustments. This work should be done only by a qualified
technician who can measure the airflow from the filter with a suitable velometer. NuAire provides one adjustment to set
the workstation airflow velocity.
This is a PWM signal adjustment via DC motor speed control.
The workstation is considered to be certifiable if the following airflow measurement is present.
Workzone average: 90LFPM ± 10 LFPM (.46 mls ± .05mls)
Before starting airflow calibration procedure, let the workstations run for at least 10 minutes.
Step 1: Air velocity readings are taken on a 12 inch (305mm) grid, in a plane parallel to and 6 inches (152mm)
from the filter surface. No reading should be taken closer than 6 inches (152mm) from the inner edge
of the filter frame.
Step 2: If necessary, adjust airflow control potentiometer, located under the removable cap plug on front panel,
to the above stated airflow requirements.
The speed control (see photo below) provides more feedback to the Service Technician in that there is a
calibration mode push button next to the potentiometer that when pushed activates the calibration
mode. There is also an LED to indicate you are in calibration mode. It will then remain in calibration
mode until no potentiometer adjustment is made for 1 minute or the LED indicator is off. At that point,
the current RPM and PWM signal values will be stored as the starting point and the calibration mode will
be exited. The calibration mode can be accessed as needed to achieve the stated airflow requirements.
Be sure to allow cabinet to run 1 minute before any blower on/off action is taken.
Potentiometer
Push Button
LED
Test Data:
Number of Readings:
Average Velocity:
Acceptance Criteria:
1. Average Velocity = 80 to 100fpm (.41 to .51mls)
2. Individual readings must be within ± 20% of the Average Velocity.
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ft./min. m/s
7.5
HEPA Filter Leak Test
In order to check filter and filter seal integrity, the HEPA filter media and seals must be directly accessible, by the measuring
instrument. The challenge material (i.e. PAO) should be supplied in the top panel of the workstation. An upstream
challenge may be taken by using the minihelic gauge pressure supply tube if desired.
The diffuser is secured by thumb screws on the sides.
Once removed the diffuser can be lifted up slightly using the small handles and removed from the cabinet.
Model Size
224
230
324
330
336
424
430
436
2
2
Filter Area (ft )(m )
4 (.113)
5 (.142)
6 (.170)
7.5 (.213)
9 (.255)
8 (.227)
10 (.283)
12 (.340)
Model Size
524
530
536
624
630
2
2
Filter Area (ft )(m )
10 (.283)
12.5 (.354)
15 (.425)
12 (.340)
15 (.425)
Laskin Nozzle Concentration Formula
# Nozzles x 135 CFM x 100 ug/L
CFM
=
Challenge
Concentration (ug/L)
# Nozzles x 229 CMH x 100 ug/L
CFM
=
Challenge
Concentration (ug/L)
7.6 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
2
ISO 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.
“At Rest Particle Count Test”
Take 5 test points in 1-minute intervals on a grid, in a horizontal plane as measured approximately 6-inches (152mm)
parallel to the diffuser. The grid location is designed as the diffuser center point and each corner measured 6-inches
(152mm) from the inside perimeter.
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
OM0209
Rev 2 October / 2012
Page 18 of 27
OM0209
Rev 2 October / 2012
Page 19 of 27
8.0
Polycarbonate Material Compatibility
8.1 Polycarbonate sheet is resistant at 70° to these chemicals.
Amyl alcohol
Aluminum chloride
Aluminum sulphate
Ammonium chloride
Ammonium nitrate
Ammonium sulphate
Antimony trichloride
Arsenic acid
Butyl alcohol
Calcium nitrate
Chlorinated Lime Paste
Chrome alum
Chromic acid (20%)
Citric acid (40%)
Copper chloride
Copper sulphate
Formic acid (10%)
Formalin (30%)
Glycerine
Heptane
Hydrochloric acid (10%)
Hydrogen peroxide (30%)
Hydrofluoric acid (10%)
Isopropyl alcohol (70%)
Lactic acid (20%)
Magnesium chloride
Magnesium sulphate
Maganese sulphate
Mercuric chloride
Nickel sulphate
Nitric acid (10%)
Nitric acid (20%)
Oleic acid
Oxalic acid
Pentane
Phosphoric acid (10%)
Potassium bromate
Potassium bromide
Potassium nitrate
Potassium perchlorate
Potassium permanganate
Potassium persulphate
Potassium sulphate
Silicone oil
Silver nitrate
Sodium bicarbonate
Sodium bisulphate
Sodium carbonate
Sodium chloride
Sodium hypochlorite
Sodium sulphate
Stannous chloride
Sulfur
Sulfuric acid (>10%)
Sulfuric acid (50%)
Tartaric acid (30%)
Zinc chloride
Zinc sulphate
8.2 Polycarbonate sheet is not resistant to these chemicals.
Acetaldehyde
Acetic acid (conc.)
Acetone
Acrylonitrile
Ammonia
Ammonium fluoride
Ammonium hydroxide
Ammonium sulfide
Benzene
Benzoic acid
Benzyl alcohol
Brake fluid
Bromobenzene
Butylic acid
Carbon tetrachloride
Carbon disulfide
Carbolic acid
OM0209
Rev 2 October / 2012
Caustic potash solution (5%)
Caustic soda solution (5%)
Chloroform
Chlorothene
Chlorobenzene
Cresol
Cutting oils
Cyclo hexanone
Cyclohexene
Dimethyl formamide
Dioxane
Ethane tetrachloride
Ethylamine
Ethylene dichloride
Ethyl ether
Ethylene chlorohydrin
Page 20 of 27
Formic acid (conc.)
Freon (refrigerant & propellant)
Gasoline
Lacquer thinner
Methyl alcohol
Methylene chloride
Nitrobezene
Nurocellulose lacquer
Ozone
Phenol
Phosphorous hydroxy chloride
Phosphorous trichloride
Proplonic acid
Pyridine
Sodium sulfide
9.0
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 workstation is running, any and all red indicators display an error.
Step 2: VERIFY ERROR INDICATORS.
Error indicators can be verified by turning the error function on/off.
Step 3: MONITOR RE-OCCURRENCE OF ERROR INDICATORS.
If re-occurrence of the error indicator is immediate or daily, use guide below to correct the situation.
Error Indicator Troubleshooting Guide
Error Indicator
Indicator
Correction
Clean bench fluorescent lights won't turn on.
Check blower/light circuit breaker on top of control center.
Check fluorescent lamps.
Check voltage to light ballasts.
Check ballast.
Check light switch.
Clean bench blower won't turn on.
Check blower/light circuit breaker on control center.
Check voltage to blower.
Check wiring to blower.
Check blower capacitor.
Check blower motor.
(Note: blower motor has internal thermal protector.
Let blower motor cool off for a minimum of 30 minutes to
assure thermal protector is not open.)
Clean bench ultraviolet light won't turn on.
Check blower/light circuit breaker on top of control center.
Check ultraviolet lamp.
Check voltage to ultraviolet ballasts.
Check ballast.
Check light switch.
Blower/lights circuit breaker continues to
trip after reset.
Check for short on output of circuit breaker.
Replace circuit breaker.
Isolate output of circuit breaker by disconnecting control
center connectors, light circuit, motor voltage regulator,
etc. to isolate the short.
Minihelic gauge
OM0209
Rev 2 October / 2012
Minihelic gauge reads
"NO" or "LOW FLOW"
Page 21 of 27
Check minihelic gauge operation.
Check for pinched tubing in control center.
Make sure airflow is not too low.
10.0
Optional Equipment
10.1 Ultraviolet Lamp
10.1.1
Overview
The germicidal ultraviolet is primarily intended for the destruction of bacteria and other micro-organisms in the air
or on directly exposed surfaces. Approximately 95% of the ultraviolet radiations from germicidal tubes are in the
253.7 nanometer region. This is the 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 workstation to provide an average intensity of 100 microwatts per
centimeter (for a new tube) falling on the horizontal plane defined by the bottom of the work surface.
The minimum requirement per paragraph 5.12 of NSF Standard 49 to 40 microwatts per square centimeter
(Reference NSF standard 49, June 1976).
The UV light on/off switch is located in the Service Control Center and is wired with the fluorescent light switch so
that the UV light cannot be used when the fluorescent light is on.
10.1.2
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.
10.1.3
Maintenance
The output of an ultraviolet lamp deteriorates with burning age.
The useful life of the lamp is approximately 7000 hrs under specific test conditions.
If the tube is turned on every day for 12 hours, the tube will last approximately two years.
It is recommended that either a time schedule be established or the tube's output be 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.
The lamp may be cleaned with a lint-free cloth dampened with alcohol or ammonia and water.
OM0209
Rev 2 October / 2012
Page 22 of 27
Energies Required to Destroy Some Microorganisms by Ultraviolet Radiations
Mold Spores
Penicillium roqueforti
Penicillium expansum
Penicillium Digitatum
Aspergillus glaucus
Aspergillus Flavus
Aspergillus niger
Rhizopus nigricans
Mucor racemosus A
Mucor racemosus B
Oospora lactis
Yeasts
Saccharaomyces
Ellipsoideus
Saccharomyces cerevisiae
Brewer's yeast
Baker's yeast
Common yeast cake
Bacteria
Strep. lactis
Strep. Hemolyticus
(alpha type)
Staph. aureus
Staph. albus
Micrococcus sphaeroides
Sarcina lutea
Pseudomonas fluorescents
Escerichia coli
Proteus vulgaris
Serratia marcescens
Bacillus subtilis
Bacillus subtilis spores
Spirillum rubrum
Microwatt Seconds
per cm/2
26,400
22,000
88,000
88,000
99,000
330,000
220,000
35,200
35,200
11,000
Protozoa
Paramecium
Microwatt Seconds
per cm/2
200,000(a)
Nematode Eggs
40,000(b)
Virus
Bacteriophage(E.Coli)
Tobacco mosaic
Influenze
6,600
440,000
3,400(d)
13,200
17,600
13,200
6,600
8,800
13,200
8,00
5,500
6,600
5,720
15,400
26,400
7,040
7,040
7,480
6,160
11,000
22,000
6,160
(a)
References
Luckiesh, Matthew (1946)
Application of Germicidal, Ethyemal and Infrared Energy D. Van Nostrand o., New York, New York. pp. 253
(b)
Hollaender, Alexander (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 1/2 inactivation) Jour. of Bact. 48, pp. 447-454
(e)
This table, "Energies Required to Destroy Some Microorganisms by Ultraviolet Radiations" comes from the
Westinghouse brochure entitled - "Westinghouse Sterilamp Germicidal Ultraviolet Tubes"
OM0209
Rev 2 October / 2012
Page 23 of 27
11.0
Electrical/Environmental Requirements
11.1 Electrical (Supply voltage fluctuations not to exceed +/- 10%)
Electrical
NU-201-224
NU-201-230
NU-201-230E
NU-201-324
NU-201-330
NU-201-330E
NU-201-424
NU-201-430
NU-201-430E
NU-201-436
NU-201-524
NU-201-530
NU-201-530E
NU-201-536
NU-201-624
NU-201-630
NU-201-630E
Voltage
115 Volts
115 Volts
230 Volts
115 Volts
115 Volts
230 Volts
115 Volts
115 Volts
230 Volts
115 Volts
115 Volts
115 Volts
230 Volts
115 Volts
115 Volts
115 Volts
230 Volts
Phase
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Frequency
60 Hz
60 Hz
50 Hz
60 Hz
60 Hz
50 Hz
60 Hz
60 Hz
50 Hz
60 Hz
60 Hz
60 Hz
50 Hz
60 Hz
60 Hz
60 Hz
50 Hz
Current
(Amps)
5
5
4
7
7
4
7
7
4
7
8
8
5
8
8
8
5
Independent Outlet Current for
Each Outlet (Optional)
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
11.2 Operational Performance (for indoor use only)
Environmental Temperature Range:
60°F - 85°F (15.6°C – 30°C)
Environmental Humidity:
20% - 60% Relative Humidity
Environment Altitude:
6562 Feet (2000M)
11.3 Light Exposure
Standard Fluorescent Lighting @ 150 ft. candles (1614 LUX) maximum intensity.
11.4 Installation Category: 2.0
Installation category (overvoltage category) defines the level of transient overvoltage which the instrument is designed to
withstand safely. It depends on the nature of the electricity supply and its overvoltage protection means. For example,
in CAT II, which is the category used for instruments in installations supplied from a supply comparable to public mains
such as hospital and research laboratories and most industrial laboratories, the expected transient overvoltage is 2500V
for a 230V supply and 1500V for a 120V supply. Main supply fluctuations are not to exceed +10% of nominal voltage.
11.5 Pollution Degree: 2.0
Pollution degree describes the amount of conductive pollution present in the operating environment. Pollution degree 2
assumes that normally only non-conductive pollution such as dust occurs with the exception of occasional conductivity
caused by condensation.
11.6 Chemical Exposure
Chemical exposure should be limited to antibacterial materials used for cleaning and disinfecting. Chlorinated and
Halogen materials are not recommended for use on stainless steel surfaces.
11.7 EMC Performance (classified for light industrial)
Emissions:
EN61326
Immunity:
EN61326
The EMC performance requirements are generated within the product
enclosure. The enclosure will be all metal grounded to earth.
In addition, the membrane front panel will also include a ground plane for
maximum protection and an electrostatic shield.
! WARNING
OM0209
Rev 2 October / 2012
Page 24 of 27
12.0
Disposal and Recycle
Workstations 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
!
CAUTION
Prior to any disassembly for disposal, the must be decontaminated.
RECYCLE
Component
Main Workstation
Worksurface
Side Panels
Side Panel
Control Center
Diffuser
Filter
Hepex Bag
Blower Wheel & Housing
Motor
Printed Wiring Assembly
Wire
Ballasts
Connectors
Hardware
LEAD FREE
Material
Painted Steel
Wood/Stainless Steel
Polycarbonate
Aluminum
Painted Steel
Aluminum
Wood
PVC
Steel
Various Steel/Copper
Lead Free Electronic
PVC Coated Copper
Various Steel, Electronic
Nylon
Stainless Steel and Steel
 Note: Material type can be verified with use of a magnet with stainless and aluminum being non-magnetic.
OM0209
Rev 2 October / 2012
Page 25 of 27
OM0209
Rev 2 October / 2012
Page 26 of 27
OM0209
Rev 2 October / 2012
Page 27 of 27
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