Labgard Class II, Type A2

Laminar Flow
Biological Safety Cabinet

Model
NU-425-200
NU-425-200E
NU-425-200G
Bench/Console

Operation & Maintenance Manual

December, 2008
Revision 4
Series 31 and Higher (NU-425-200)
Series 23 and Higher (NU-425-200E)
Series 21 and Higher (NU-425-200G)

(115V Only) (115V 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

OM0140
Congratulations!

You have just purchased one of the finest Laminar Flow Biological Safety Cabinets available. With
proper care, maintenance (certification), and laboratory procedure, this cabinet will give you years of product
and personnel protection from particulate contaminants as prescribed in NSF/ANSI 49:2002. 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

Acknowledgment
NuAire, Inc. acknowledges that some material in this manual reflects information supplied by the National Institutes of Health personnel both in verbal
and written specifications. In particular, NuAire acknowledges that information in Selection 8 was obtained from the following sources:

1. Technical Report No. FPS 56500000001. Prepared by Dow Chemical Co., for the National Cancer Institute, May 1, 1972.

2. Stolar MH, Power LA, Vielo CS: Recommendations for handling cytotoxic drugs in hospitals. Am J Hosp Pharm 1983;40: 1163-1171.

3. Anderson R.W., Director of Pharmacy, University of Texas, M.D. Anderson Hospital and Tumar Institute at Houston.

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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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 Labgard Class II, Type A2
Laminar Flow Biological Safety Cabinet
Model
NU-425-200
NU-425-200E
NU-425-200G
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 ........................................................ Certification Testing Methods and Equipment
Section No. 6 .................................................... Operating the NU-425-200
6.1 ........................................................ Operator Controls & Indicators
6.2 ........................................................ Operating Guidelines
6.3 ........................................................ Operating Sequence
6.4 ........................................................ Ergonomics
6.5 ........................................................ Cleaning Procedures
6.6 ........................................................ Hazardous Drug Decontamination Procedures
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 ........................................................ Site Installation Assessment Test
7.9 ........................................................ Cleanliness Classification Test For Pharmacy Application
Section No. 8 .................................................... Error Indicatiors & Troubleshooting
Section No. 9 .................................................... Remote Contacts
Section No. 10 .................................................. Optional Equipment
10.1 ...................................................... Ultraviolet Light
Section No. 11 ......................................................... Electrical/Environmental Requirements
Section No. 12 ......................................................... Disposal and Recycle
Insert................................................................. Replacement Parts List

MANUAL DRAWINGS
BCD-09324 .................................... NU-425-200 Airflow Schematic
BCD-09325 .................................... NU-425-200 Specification Drawing
BCD-05322 .................................... Front Panel Controls & Indicators

ASSEMBLY DRAWINGS
BCD-09328 ........................Base Stand Assembly NU-425-200
BCD-09326 ........................HEPA Filter/Motor Replacement

ELECTRICAL SCHEMATICS
BCD-12913 ........................NU-425-200 Electrical Schematic
BCD-12821 ........................NU-425-200E/G Electrical Schematic

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 Labgard Class II, Type A2
Laminar Flow Biological Safety Cabinet
Models
NU-425-200
NU-425-200E
NU-425-200G
MANUFACTURED BY:
NuAire, Inc. - Plymouth, Minnesota, U.S.A.

1.0 General Description

The LABGARD Model NU-425 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 Laminar Flow Biological Safety Cabinet, (LFBSC) is a product resulting from the development of
the "laminar flow" principle 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-425 bench LFBSC is known as a Class II, Type A2 Biological Safety Cabinet. This is possible
since NuAire's cabinet conforms to the following requirements:

1. Maintains 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. Exhaust airflow can either be room re-circulated or exhausted outside using a canopy exhaust
transition.

4. Has all biologically contaminated ducts and plenums under negative pressure or surrounded by
negative pressure. (Type A1 permits positive pressure contaminated ducts and plenums).

Cabinets used for work with minute quantities of volatile toxic chemicals and traces amounts of
radionuclides required as an adjunct to microbiological studies must be exhausted through
properly functioning exhaust canopies.

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1.2 Safety Instructions
These safety instructions describe the safety features of the LABGARD Model NU-425 LFBSC. The
safety cabinet 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 safety cabinet 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 cabinet 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.

1.3 Explanation of Symbols

WARNING indicates a potentially hazardous
! WARNING situation which, if not avoided, could result in
death of serious injury.

CAUTION indicates a potentially hazardous

! CAUTION: situation which, if not avoided, may result in
minor or moderate injury.

CAUTION used without the safety alert symbol

CAUTION 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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OM0140 7
2.0 Models & Features
The model NU-425-200/E/G is a Class II, Type A2 Laminar Flow Biological Safety Cabinet.

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OM0140 9
3.0 Warranty
NuAire, Inc. warrants 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 in its equipment within 36 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 LABGARD 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 LABGARD cabinet 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, 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.

If drafts or other disruptive air currents exceed the intake velocity of the cabinet through the access
opening, the potential exists for contaminated air to exit or enter the work tray 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 twelve (12) inch (305mm) 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. A MINIMUM CLEARANCE OF 6" (152MM) IS
REQUIRED FROM THE TOP OF THE CABINET TO THE CEILING FOR PROPER
VENTILATION OF THE EXHAUST EFFLUX. HOWEVER, FOR CERTIFICATION OR
COMMISSIONING,
18 INCHES (457MM) IS REQUIRED TO OBTAIN VALID EXHAUST MEASUREMENTS.

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)
Gas-Tight Exhaust Transitions

 NOTE: THE EXHAUST SYSTEM SHOULD BE FITTED WITH A BACKDRAFT

DAMPER TO PREVENT REVERSING OF AIRFLOW IN THE SYSTEM.

Both types of transitions have some common attributes, in addition to some that are unique. NuAire
strongly recommends a canopy or thimble exhaust for most applications. See separate instruction
sheets for a discussion of exhaust transitions and installation requirements.

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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
holding the cabinet to the skid and unbolting the strap from the front flange to the base skid.

5.2.1 Base Stand Assembly

The base stand is shipped K.D. in a separate carton and is assembled per drawing BCD-09328
if accompanied with the unit. In order to insure that the base stand is dimensionally stable, the
following procedure must be followed.

1. Assemble end stands (2), cross members (2), and rear corner brackets (2) as shown in
Isometric A, B and C (Please note rear corner bracket orientation).
2. Place the base stand in its final desired position and loosely attach the floor mounting
anchor brackets.
3. Mark the floor anchor bracket hole locations and drill pilot holes for appropriate anchor
type; 1/2" (13mm) diameter x 1-1/4" (32mm) deep for concrete floor type -- 11/64
diameter for 1/4" (6mm) lag screws.

4. Fasten the anchor bracket to the floor, while leaving the anchor bracket loosely
attached to the end frames.

5. Using a level place on the base stand crossmembers, adjust the leg levelers, first end-to-
end, then front-to-back. The leg levelers provide  3/4” (19mm) adjustment.

6. Tighten floor anchor bracket to end stand.

7. Lift the cabinet onto the rear corner brackets.

8. Fasten the front corner bracket to the end stand and the cabinet as shown in Isometric
A.

9. Install the drain valve on the bottom right front of the cabinet, using Loctite 242
(furnished) to the threads and rotate the valve body until it is secure.

5.2.2 Bench Installation

Place the cabinet on the bench with approximately a two (2) inch (51mm) overhang clearance
for installation of the drain valve. If the drain valve is not desired, place the cabinet in its
desired location and using RTV caulk, seal all around the base of the cabinet and the bench.
this provides a tight seal to prevent bench spills from migrating under the cabinet.

If a drain valve is desired, remove the handle from the valve stem 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 1-1/2 inch (38mm) overhang and seal the interface of the bench
and cabinet, using RTV caulk as above.

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 5.2.3 Gas Service
NuAire doesn't recommend the use of natural gas within the LFBSC, but if gas service is
determined to be necessary for the application, appropriate safety measures must take place.
All NuAire LFBSC's have precautionary warning labels that say the following:

! CAUTION: Use of explosive or flammable substances in this cabinet

should be evaluated by your appropriate safety personnel.

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 LFBSC ON THE GAS SUPPLY LINE.

All NuAire LFBSC's 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 LFBSC and
ASSUMES NO RESPONSIBILITY FOR ITS USE. USE AT YOUR OWN RISK. The
Bunsen burner flame within the LFBSC 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.

5.2.4 Plumbing Services (Optional)

Service ball valves with the type of service specified by the removable button on the handle, are
located in the work zone. Theservice ball valves are not recommended for pressure over 75
p.s.i (5.2 Bar). Reducing valves should be installed external to the cabinet if necessary.
Service ball valves should never be used for oxygen service. A special needle valve for
oxygen service or certified valve is required and available upon request.

External connection is to 3/8 inch NPT coupling in the inner side walls. 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.

5.2.5 Electrical Services

The NU-425 Series Biological Safety Cabinets may be "hardwired" (optional) or connected via
an electrical power cord which is standard. The unit requires 115, 220 or 230 VAC 50/60 Hz,
single phase (current rating varies per cabinet size, reference Electrical/Environmental
Requirements). It is recommended that power to the unit be on its own circuit, protected with a
circuit breaker or fuse at the distribution panel.

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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 5.2.6 Final Assembly
REMOVE THE PROTECTIVE CARDBOARD COVER OVER THE EXHAUST HEPA,
located under the protective screen. 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.

5.3 Certification Testing Methods and Equipment

After installation prior to use, NuAire recommends that the cabinet be recertified to factory standards.
At a minimum, the following tests should be performed.

1. HEPA filter leak test

2. Downflow velocity test
3. Inflow velocity test
4. Airflow smoke patterns
5. Site installation assessment tests

The testing methods and equipment required are specified on the factory inspections report included
with this manual (see insert in back cover).

IT IS RECOMMENDED THAT THESE TESTS BE PERFORMED BY A QUALIFIED

TECHNICIAN WHO IS FAMILIAR WITH THE METHODS AND PROCEDURES FOR
CERTIFYING BIOLOGICAL SAFETY CABINETS (SEE INSERT).

AFTER THE INITIAL CERTIFICATION, NUAIRE RECOMMENDS THAT THE CABINET

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 LABGARD 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 certification to the performance requirements should be accomplished as stated
to ensure biological safety established by the factory standards.

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6.0 Operating the NU-425
6.1 Operator Controls & Indicators
The following is a description of the controls and indicators found on both the front panel (see Drawing
BCD-05322) and cabinet.

6.1.1 Circuit Breaker-Blower (Left side of Control Center)

The motor/blower 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 (pop-out button will appear) merely depress 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.

6.1.2 Circuit Breaker-Outlets (Left side of Control Center)

The duplex outlet located in the sidewall of the work area is protected with a 3 Amp circuit
breaker. The circuit breaker may trip at 110% of load rating but will trip at 145% of load rating
in less than 2 seconds. Should the circuit breaker open, (pop-out button will appear), unplug the
appliance plugged into the outlet and merely depress the pop-out button to reset.

6.1.3 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. The
UV light is also interlocked, so it will only operate if the sliding window is closed. Proper care
should be exercised when the UV light is on.

6.1.4 Outlet Switch

This switch provides on/off control for the 115 VAC power available in the outlet(s) within the
cabinet workzone.

6.1.5 Blower Switch

The blower switch applies power to the internal motor/blower when in the ON position. The
blower switch also has a second set of poles, which are available for use as a contact closure for
an exhaust system. In addition, power can be applied to the accessory outlet located on the
upper left corner in back of the control center.

The purpose of the outlet is to provide "switched" power for the following:

1) Exhaust transition with integral blower

2) To power a low power appliance, such as the low airflow alarm.

The rating of the outlet is 115 VAC at 1 Amp maximum.

6.1.6 Indicator Light

An indicator light is located above the blower on/off switch and indicates when power is
applied to the blower.

6.1.7 Audible Alarm Enable

As the sliding window is raised above its normal working height, a micro switch located in the
glide channel activates both an audible and visual alarm. This switch disables the audible alarm
but will not disable the red indicator visual alarm.

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OM0140 16
 6.1.8 Airflow Control
The operating airflows within the cabinet (i.e. 70 LFPM (.35 m/s) downflow and 105 LFPM
(.53 m/s) air inflow barrier) are controlled by a potentiometer and an exhaust damper. The
potentiometer controls the operating voltage applied to the motor/blower. The potentiometer is
adjustable over 270 degrees with a slotted screwdriver, which varies the applied voltage from
70 to 115 VAC. THIS ADJUSTMENT SHOULD ONLY BE MADE BY A QUALIFIED
TECHNICIAN EMPLOYING THE PROPER INSTRUMENTS IN ORDER TO INSURE
AIRFLOWS PER NSF STD. NO. 49.

6.1.9 Minihelic Gauge

The unit is equipped with a minihelic gauge. The minihelic gauge displays the static pressure
within the pressure plenum supplying the downflow and exhaust filters. The gauge is
calibrated in "inches of water gauge" pressure. As the HEPA filters load with particulate
matter, the amount of static pressure will increase, giving and indication of the "health" of the
cabinet. The initial pressure reading will be approximately 0.5" w.g. + 0.1" w.g. depending on
altitude from sea level. At each 0.1" w.g. increment increase, the cabinet airflow should be
checked by a qualified technician, unless certified on a yearly (or sooner) basis.

6.1.10 Sliding Window Operation

The cabinet has a full counter balanced and removable sliding tempered glass window with two
operational features. As the window is raised above its specified operating height, an audible
alarm alerts the operator of possible compromised personnel protection. At the same time, an
audible and visual alarm is activated. The audible alarm may be switched off while the visual
alarm remains until lowered to the safe operating position. When the window is lowered below
2 inches (51mm), the motor/blower automatically shuts down, to prevent stress on the
motor/blower in the form of overheating. The maximum window height is 19-1/2 inches
(495mm).

6.1.11 Convenience/Accessory Outlet (115 VAC only)

A convenience/accessory outlet is located in the upper left hand corner in back of the control
panel. The outlet is normally wired "hot" through the motor/blower circuit breaker. If an
accessory is purchased, the outlet is defined as an accessory outlet supplying 115 VAC at 1.0
Amp maximum, and is wired to the blower switch (see Electrical Schematic).

OM0140 17
 6.2 Operating Guidelines
The intent herein is to present general operational guidelines that will aid in the use of the Laminar
Flow Biological Safety Cabinet (LFBSC) to control airborne contaminants of low to moderate risk as
stated in Technical Report No. FPS 56500000001 prepared by Dow Chemical U.S.A. for the National
Cancer Institute, May 1, 1972.

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 you "Safe Work Area"

b. Minimize disruption of "air curtain"
c. Minimize room activity
d. Utilize unidirectional air flow
e. Employ aseptic techniques

6.2.1 Know Your "Safe Working Area"

The LFBSC safe working area is basically the worktray or depressed area. All work should be
performed on or above the worktray. The area on or above the front grill is a non-safe working
area.

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 raising 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.

6.2.3 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 a cabinet can cause draft velocities up to 175 fpm, which are sufficient to disrupt
the air balance of the laminar flow unit.

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 6.2.4 Utilize Unidirectional Air Flow
The operator must keep two important facts in mind: (1) The air, as supplied to the work area
through filters from the top, is contaminant free and (2) Airborne contamination generated in
the work area is controlled by the unidirectional flow of parallel air streams in a top-to-bottom
direction.

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.

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 work space where resulting air
turbulence will have a minimal effect. If cabinet air is inadvertently turned off, the flame could
damage the HEPA filters.

OM0140 19
 6.3 Operating Sequence

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. Many of the cabinets are provided with magnehelic gauges which
indicate pressure differentials across the supply filters. They may indicate to the LFBSC
maintenance technician when to replace the filters, dependent upon the blower fan capacity.
Blower speed must only be readjusted by qualified maintenance technicians.

 Note: Some cabinets 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
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) by
wiping them thoroughly with 70% alcohol or similar non-corrosive antimicrobial agents. DO
NOT USE ANY CHLORINATED OR HALOGEN MATERIALS IN THE CABINET.

6.3.3 Materials & Equipment

The apparatus and materials should next be placed into the cabinet. Care must be exercised that
no items be placed over the front intake grills. Materials should be arranged so that clean, dirty
(used), and virus materials are well separated. Passage of contaminated materials over
uninoculated cultures or clean glassware should be avoided and transfer of viable materials
should be performed as deeply into the cabinet (away from open face) as possible.

6.3.4 Air Purge

Additional purging of the work space 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.

OM0140 20
 6.3.5 Perform Work
The work can now be performed. The technician performing the work is encouraged to wear a
long-sleeved gown with knit cuffs and rubber gloves. This will minimize the shedding of skin
flora into the work area and concurrently protect the hands and arms from viable agent
contamination. At a minimum, the hands and arms should be washed well with germicidal soap
before and after work in the cabinet. For the preparation of antineoplastic drugs, the following
procedures summarize those contained in OSHA Instruction PUB 8-1.1, "Work Practice
Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs." The above
document should be thoroughly studied/reviewed prior to drug preparation in the cabinet.

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 ampules, care should be taken to insure that no liquid remains in the tip of the
ampule. A sterile gauze sponge should be wrapped around the neck of the ampule 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.

6.3.6 Terminal Purging & Wipedown

Following completion of work, allow the cabinet to run for 2-3 minute period without
personnel activity to purge the unit. The decontamination of the interior surfaces should be
repeated after removal of all materials, cultures, apparatus, etc. A careful check of grills and
diffuser grids should be made for spilled or splashed nutrients which may support fungus
growth and resulting spore liberation that contaminates the protected work environment.

6.3.7 Paper Catch

A permanent paper catch is installed behind the rear divider panel of the work zone. This area
forms the return air path to the motor/blower; and if the air flow is blocked, it could seriously
affect the performance of the cabinet. Therefore, THE PAPER CATCH SHOULD BE
CHECKED AND CLEANED NO LESS THAN A WEEKLY BASIS; DAILY basis if
procedures dictate the use of paper products. Any paper removed must be properly disposed of
as Contaminated Hazardous Waste.

6.3.8 Shut Down

Turn off blowers and lights. Do not use cabinet as a depository for excess lab equipment
during periods of non-operation. If antineoplastic agents are being prepared in the cabinet, it is
recommended to let the cabinet run 24 hours per day. This lessens the possibility that
contaminants may escape.

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

OM0140 21
 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/armrest support - The cabinet 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.
 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.

6.4.3 Assembly

a. Replace front (if removed) grill.

b. Replace the work tray and carefully tighten the thumb screws.
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.

6.5 Cleaning Procedures

Cleaning the cabinet is an important function in terms of both containment and sterility. Use the
following procedure to effectively clean or surface disinfect the cabinet workzone surfaces.

a. Raise the sliding window to a full-open position, if desired.

b. Press the audible alarm silence or cleaning key on the front control panel to
silence the audible alarm during the cleaning process.

c. Apply appropriate disinfecting solution to cabinet surfaces. Most surface disinfectants require
a specific contact time, depending upon the microbiological agents used within the cabinet.
CONSULT APPROPRIATE DISINFECTANT DOCUMENTATION FOR PROPER
APPLICATION AND SAFETY PRECAUTIONS.

 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.

OM0140 22
 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. plastic.

6.6.1 Preparation
Prior to beginning decontamination activity, personnel should put on a Tyvek1 isolation gown,
2 pair of vinyl 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, the term CLEANING is
defined as the operation of wiping down with a cloth wetted with a clean hot (above 60C)
detergent solution, followed by wiping down repeatedly with sterile water to rinse. All cloths
shall be contained in 4 mil plastic bags and labeled for disposal as chemotherapy waste.

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.

CAUTION: With the view screen in the full open position, personnel protection is compromised
! and a full faced HEPA filtered respirator must be worn.

c. Clean all readily accessible surfaces of the cabinet.

d. Remove perforated metal diffuser screen from the underside of the supply HEPA filter and
place on the cabinet work tray.

 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 an 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.

1 Available from Lab Safety Supply, Janesville, WI 53547-1368, or other laboratory, industrial, or hospital supply distributors

OM0140 23
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 Decontamination
No maintenance should be performed on the interior of the Labgard 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.

CAUTION! Hazardous Gases! Personal Protection Equipment Required.

!
A disinfection using formaldehyde must be performed in accordance with the specifications of NSF
49/1992, Annex G.

This procedure presents considerable risks and must be performed only by specially
trained
and authorized service personnel in accordance with applicable safety regulations.

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.

CAUTION! Flammable Hazard!

!
Formalin is flammable. The auto-ignition temperature of formalin is 430 C (820° F).

With a volume percentage of 7.75% in dry air, formaldehyde vapor may explode.

For vaporization, do not use heating devices reaching temperatures above 250° C (477° F).

CAUTION! Chemical Hazard!

!
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.

If microbiological decontamination is necessary, use the following procedure:

1. Remove screws at each upper side of the control center and allow the control center to rotate down,
resting on the safety straps. Remove control center by disconnecting safety straps and moving control
center to the left off the slip hinges.
2. Remove the front decorative panel via top/front fasteners.
3. Remove left and right window farings via fasteners.
4. Remove armrest via fasteners.
5. Place decontamination equipment inside the work area. Reference decontamination procedure, per NSF
Standard 49, Annex G, using the following chart to calculate chemical requirements.

OM0140 24
 Cabinet Size 200
Cabinet 48 x 24 x 24-1/2 in.
Dimensions (1.22 x .61 x .62 m)
Cabinet Volume 16.3 cu. ft.
(.462 cu. m)

 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 or run
the decontamination power cords under the front seal area.

4. Use duct tape and plastic to seal the front and exhaust area.

CAUTION: BE SURE CABINET IS TOTALLY SEALED TO

! PREVENT ANY LABORATORY EXPOSURE TO
` DECONTAMINATION GAS.

5. Perform decontamination procedure per NSF Standard 49, Annex G.

If the cabinet has been used to prepare hazardous drugs, (chemotherapy), or other toxic chemicals,
decontamination of the cabinet cannot be accomplished by the above procedure. (See section 6.6 for
guidelines)

Please consult with NuAire, Inc. about any unique contamination problems.

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 distributors.

OM0140 25
 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.

To replace a bulb, it is necessary to remove the lamp assembly.

1. First, switch Cabinet Light Switch off.

2. Second, remove the screws at each upper side of the Control Center and allow the Control
Center to rotate down, resting on the safety straps.

3. The bulb is now directly exposed for replacement.

4. The bulb is removed by displacing the bulb to one side against the compressible bulb holder
and lifting out the bulb.

5. Reverse the procedure to reinstall the lamp assembly being careful not to pinch the safety
straps, cable or tubing during closure of the control center.

7.3 HEPA Filter/Motor Replacement (Drawing BCD-09326)

The HEPA Filters under normal usage and barring an accident (a puncture), do not need replacement
until the efflux velocity cannot be maintained or the access inflow velocity cannot be maintained at 100
LFPM (.51 m/s) (min.). This may permit the average downflow velocity to be as low as 65 LFPM (.32
m/s) as long as no point falls below 20% of the average downflow velocity.

The HEPA Filters should not be replaced until the entire cabinet has been decontaminated or known to
be biologically "clean".

7.3.1 Procedure

CAUTION: Disconnect electrical power from the unit before attempting any maintenance action.

Step 1: Remove the sliding window assembly.

a. First rotate up the hinged Control Center.

(Hold up or remove the control center. Do not use support rod to hold in place).

b. Second, remove the stainless steel front window trim.

c. Third, remove (4) 1/4-20 acorn nuts and related hardware so that sliding window assembly may
be lifted away from cabinet.

Step 2: Remove the supply and exhaust filter cover.

CAUTION: Screws are used in lieu of acorn nuts, and lockwashers. The screws have O-rings and
should be replaced if damaged or badly deformed.

The interior of the cabinet is now fully exposed for replacement of the filters and/or motor/blower.

OM0140 26
 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 always falls off while the exhaust increases (i.e. greater than 100
LFPM), the supply filter is "loading" faster than the exhaust filter, and only the supply filter may need
replacement.

a. To remove the supply filter "A":

1. First, remove the HEPEX/choke tray band clamp between the supply HEPEX and the
exhaust filter choke tray. Separate the plenum from the choke tray.

 Note: Double sticky back gasket is used to hold the plenum to the choke tray and
should be replaced when reassembling.

2. Remove the 2 hold-down clips (1 each side) holding the filter to the frame.

3. Remove the HEPEX pressure plenum from the blower assembly.

The HEPEX is clamped to the blower assembly via a clamp.

4. Carefully remove the supply filter and HEPEX. The HEPEX can be folded neatly to
seal the contaminated side of the HEPA. 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 filters of the same rated flow and size as
originally installed. It is recommended that a new HEPEX/Supply filter be installed since the HEPEX
is factory installed to the filter. However, field installation kits are available separately from the filter.

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, grease the top and bottom gaskets of the filter with silicone grease
and carefully insert into the exhaust choke tray.

c. 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).

OM0140 27
 Step 5: Motor/Blower Assembly Removal

 Note: Removal and replacement of the motor/blower may best be performed with the supply HEPA
filter/HEPEX removed to reduce the chance of damage to the fragile HEPA filter media.
Perform step 3.a. and place the supply in a secure location where it will not get damaged.

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.

7.4 Sliding Window Replacement & Adjustment

The sliding window replacement is accomplished by removing the front decorative panel, control center
and window glide assemblies. The sliding window adjustment may be required due to everyday use
over the life of the cabinet. The window glides can be adjusted by loosening the frame fasteners and
moving them closer or farther apart. When adjusting the sliding window, be sure to verify proper
microswitch operation. If the sliding window is too loose, the sliding window will not properly activate
the microswitches, thus causing potential operational malfunctions to occur.

7.5 Airflow Calibration

The NU-425-200 Airflow Calibration consists of adjustments to balance the airflow within the cabinet.
THIS WORK SHOULD BE DONE ONLY BY A QUALIFIED TECHNICIAN WHO CAN
MEASURE THE AIRFLOW FROM THE FILTERS WITH A SUITABLE VELOMETER.
NuAire provides two adjustments to balance the airflow within the cabinet. These are:

a. Blower speed adjustment via motor voltage regulator

b. Exhaust filter choke

The blower speed control system adjusts the cabinet's total volume of airflow 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, both adjustments are necessary for proper
cabinet performance.

The cabinet is considered to be certifiable if the following airflow measurements are present:

a. Downflow average: 70 LFPM + 5 LFPM (.35 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. Both values are published in the NSF
or NuAire listing.

BEFORE STARTING AIRFLOW CALIBRATION PROCEDURE. LET THE CABINET RUN FOR AT
LEAST 10 MINUTES.

OM0140 28
 7.5.1 Downflow Calibration
Step 1:  Place a velometer in the cabinet workzone on the horizontal plane defined
by 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, adjust airflow control potentiometer, located under the

removable cap plug on front panel, to the above stated airflow
requirements.

Step 3:  Proceed to inflow calibration

7.5.2 Inflow Calibration

Step 1:  Measure the inflow velocity using the recommended procedure found in
Table 7.0. If necessary, adjust the exhaust filter choke, located under the
front decorative panel, to achieve the correct average inflow velocity
within the stated range of 105  5 LFPM (.53  .025 m/s).

 Less than 100 LFPM (.51 m/s);

First, open the choke plate or make sure it is open. If this is insufficient,
then increase the motor speed control.

 Greater than 110 LFPM (.56 m/s);

First, adjust the motor speed control to achieve 1/2 the exhaust excess, and
then close the choke plate to achieve the balance. In this fashion, the
downflow should remain nearly constant (i.e. what the reduced speed took
away, the choke plate restores).

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.

Step 3:  Perform the airflow or pressure alarm test (when installed) as part of the
Site Installation Assessment Test in section 7.8.

7.6 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
rear center of the workzone over the intake slots. The upstream challenge port being common for both
filters in located on top of the cabinet.

OM0140 29
 7.6.1 Supply Filter
The diffuser plate placed below the HEPA to protect the filter during normal usage may be
removed as follows: The diffuser is secured to the cabinet shell by #1/4-20 acorn nuts located
immediately behind the front viewing window. After removing the fasteners, drop the front of
the diffuser plate several inches and pull forward gently. Note that the diffuser is purposely a
tight fit - it is held to the back wall of the cabinet interior by a light push - fit with projecting
studs.

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).

Model Size *Supply Area (ft2)(m2) Exhaust Area (ft2)(m2)

200 3.23 (.091) .97 (.027)
* Measured 4 inches above the bottom edge of the window.

Laskin Nozzle Concentration Formula

# Nozzles x 135 CFM x 100 ug/L = Challenge

Downflow (CFM) + Exhaust (CFM) Concentration (ug/L)

# Nozzles x 229 CMH x 100 ug/L = Challenge

Downflow (CMH) + Exhaust (CFM) Concentration (ug/L)

7.7 Airflow Smoke Pattern Test

The airflow smoke pattern test is performed using a smoke source (i.e. smoke tubes) in and around the
cabinet workzone and access opening to determine a visual representation of the cabinet’s containment
performance.
To perform the test, the smoke source should be passed through the following areas:

1. A smoke source shall be passed from one end of the cabinet to the other, along the center line of
the
work surface, at a height of 4 inches (102mm) above the top of the access opening.
2. A smoke source shall be passed from one end of the cabinet to the other, 1 inch (25mm) just
inside
the view screen, at a height 6 inches (152mm) above the top of the access opening.
3. Pass a smoke source along the edges of the entire perimeter of the work opening approximately
1.5
inches (38mm) outside the cabinet, with particular attention paid to corners and vertical edges.
4. Pass a smoke source 2 inches (51mm) from the sides up inside of the window at the side channel
seals, and along inside of the cabinet along the top of the work area or immediately below the
wiper gasket.

The criteria used to evaluate the smoke patterns is the following:

1. The smoke inside the cabinet shall show smooth downward flow with no dead spots or reflux.
2. No smoke shall escape from inside the cabinet.
3. No smoke refluxes out of the cabinet once drawn in, nor does smoke billow over the
worksurface
or penetrate onto it.
4. No smoke shall escape from the cabinet.
OM0140 30
 7.8 Site Installation Assessment Tests
These tests are performed to verify the sash position, airflow or pressure setpoint where an audible
and/or visual alarm will activate to signify unfavorable operating conditions within the biological safety
cabinet and/or the remote exhaust blower, and canopy connection performance.

7.8.1 Sash Alarm

Step 1: With sash alarm switch enabled, raise the sliding sash 1” (25mm) above the
manufacturer’s designated sash height for normal operation. Verify that the audible/visual
alarm activates/sounds.

Step 2: Return the sash to its normal operating height.

7.8.2 Airflow or Pressure Alarm (when installed)

Step 1: Measure and record the speed control operating voltage at the speed control test points using a
voltmeter.

Step 2: Using the primary or secondary inflow test method, lower the speed control voltage to reduce
the inflow by 20% from the certified testing value.

Step 3: Verify that the alarm activates when the inflow is dropped to this point.

Step 4: Adjust alarm setpoint as necessary as instructed by the alarm manufacturer procedures.

Step 5: Return the speed control to its certified operating voltage as measured by the voltmeter.

7.8.3 Exhaust System Performance

This test is broken up into two groups based on the external venting configuration of the exhaust
connection.

Canopy, Thimble or Air Gap Exhaust Transitions

Step 1: Using a visible smoke source, verify negative pressure at the gap. No smoke shall escape into
the room from the canopy once it enters the exhaust system.

Step 2: Measure the duct static pressure between the air gap and any duct-mounted balancing dampers.
The gap should be adjusted to under a slight negative pressure (approx. -0.02 to -0.04”W.C.
(-5 to -10 Pa)) in relation to outside air.

Gas-Tight Exhaust Transition

Step 1: Measure the duct static pressure between the exhaust HEPA filter and any duct-mounted
balancing dampers. The transition should be adjusted to be under a slight negative pressure
(approx. -0.02 to -0.04”W.C. (.5 to -10 Pa)) in relation to outside air.

 NOTE: Positive pressure ductwork conditions are strongly discouraged. Positive pressure ductwork conditions
should be reviewed and evaluated by a cognizant Safety Officer of Industrial Hygienist as part of their
Laboratory Ventilation Management Program and Chemical Hygiene Plan.

OM0140 31
 7.9 Cleanliness Classification Test for Pharmacy Application
If this cabinet is going to be used within pharmacy, per USP7971, the cabinet must be tested to assure
compliance to ISO 14644-1:1999, Cleanrooms and Associated Controlled Environments, Part 1:
Classification of Air Cleanliness2. 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.

“Operational Particle Count Test3”

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) above the worksurface. The grid location is designed as the workzone centerpoint 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

OM0140 32
 Table 7.0
Recommended Measurement Methods for Cabinet Downflow & Inflow

A. Downflow Measurement

a. 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 readings should be taken closer than 6 inches (152mm) from the inside
perimeter.

c. Test Data - Inches (mm):

6 12 18
200
(152) (305) (457)
6
(152)
12
(305)

Number of Readings: Average Velocity ft./min.(m/s)

d. Acceptance Criteria:
1. Average downflow velocity = 65 to 75 fpm (.33 to .38 m/s)

2. Individual readings must be within +20 percent of the average downflow velocity.
_____ to _____ fpm ( _____ to _____ m/s)

e. Meets Acceptance Criteria: Yes ____ No____

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. The DIM
Instrument should be equipped with a flowhood that is as close as possible to the width of the cabinet.
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 (1.36 ft2
/.126 m2 ) area to calculate inflow velocity.

OM0140 33
 Alternate Procedure:
a. 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.

c. Test Data - Inches (mm):

1. Dim Measurement
Inflow Volume ft.3/min.(m3/s) Access Opening ft.2(m2) Inflow Velocity ft./min(mps)
2 2
(1.36 ft. /.126 m )

d. Constricted 3 inch (76mm) high access opening measurement - Inches (mm):

200 4 8.125 12.250 16.375 20.500

(102) (206) (311) (416) (521)

Number of Readings: Average Velocity of Constricted Area ft./min.(mps)

Average Velocity fpm (mps) X Constricted Area ft2 (m2) = Constricted CFM (m3/s)
of Constricted Area .51 ft2 (.047 m2 ) Area Volume

Constricted Area Volume CFM (m3/s)  8" (203mm) ft2 (m2)= Average Velocity fpm (mps)
Access Window Area of 8" (203mm) Access
1.36 ft2 (.126 m2 ) Window Area

Average Velocity of 8" fpm (mps) X Correction Factor =Average Inflow Velocity fpm (mps)
Access Window Area .97

d. Acceptance Criteria:
1. Access Opening Inflow Velocity = 100 to 110 fpm (.51 to .56 m/s)

e. Meets Acceptance Criteria: Yes ______ No ______

OM0140 34
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.

Step 2: VERIFY ERROR INDICATORS. Error indicators can be verified by turning the errored 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

Window alarm Sliding window is above its Verify standard working height and
standard working height or window microswitch operation.
microswitch is not operating
properly.

Cabinet fluorescent lights won't Check blower/light circuit breaker

turn on. on top of control center. Check
fluorescent lamps. Check voltage to
light ballasts. Check ballast. Check
light switch.

Cabinet blower won't turn on. Check sliding window for correct
operational height. Check
blower/light circuit breaker on top
of control center. Check voltage to
blower. At motor voltage regulator
and at bulkhead connector. Check
wiring to blower. Check blower
capacitor. Check sliding window
blower cutoff microswitch. 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.)

OM0140 35
 Error Indicator Indicator Correction

Cabinet outlets won't turn on. Check outlet circuit breaker on top
of control center. Check voltage to
outlets.

Cabinet ultraviolet light won't turn Check blower/light circuit breaker

on. on top of control center. Check
ultraviolet lamp. Check voltage to
ultraviolet ballasts. Check ballast.
Check light switch.

Blower/lights circuit breaker Check for short on output of circuit

continues to trip after reset. 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 Minihelic gauge reads Check minihelic gauge operation.

"NO" or "LOW FLOW" Check for pinched tubing in control
center. Make sure airflow is not too
low.

9.0 Remote Contacts

9.1 Fan Relay

The fan relay contacts are single pole normally open contact closure outputs which are activated
whenever the blower is turned on. The contact points are located on the blower switch. Contact ratings
are 250 VAC maximum at 2 Amps.

OM0140 36
10.0 Optional Equipment
10.1 Ultraviolet Lamp

! CAUTION: Ultraviolet light will injure your eyes. Avoid direct viewing at all times.
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 radiations from germicidal tubes are in the 253.7 manometer region. This is a region
in the ultraviolet spectrum which is near the peak of germicidal effectiveness. The exposure
necessary to kill the 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
square 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.

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.

OM0140 37
 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"

OM0140 38
11.0 Electrical/Environmental Requirements
11.1 Electrical: (Supply voltage fluctuations not to exceed + 10%)

* NU-425-200 115 VAC, 60 Hz, 1 Phase, 9 Amps

**NU-425-200E 230 VAC, 50 Hz, 1 Phase, 5 Amps
NU-425-200G 220 VAC, 60 Hz, 1 Phase, 5 Amps

*UL Listed **CE Certified

11.2 Operational Performance (for indoor use only)

Environment Temperature Range: 60F - 85F (15.6C - 30C)
Environment Humidity: 20% - 60% Relative Humidity
Environment Altitude 6562 Feet (2000 Meters) Maximum

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 means, such as hospital and research
laboratories and most industrial laboratories, the expected transient overvoltage is 2500 V for a 230 V
supply and 1500 V for a 120 V supply.

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. Chamber decontamination can be accomplished by
paraformaldehyde, vapor phased Hydrogen Peroxide or Ethylene Oxide without degradation of cabinet
materials.

11.7 EMC Performance (classified for light industrial)

Emissions: EN61326
Immunity: EN61326

 NOTE: 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.

OM0140 39
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

! CAUTION Prior to any disassembly for disposal, the cabinet must be

decontaminated.

RECYCLE LEAD FREE

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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