Not For Sale: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification
Not For Sale: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification
Not For Sale: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification
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Annex E1
(informative)
E.1
A biosafety officer or qualified safety professional should be consulted prior to a BSC purchase. Some
institutions have biosafety cabinet purchases approved by the biosafety officer or qualified safety
professional after consultation with the user, architect and engineer. Biosafety officers or qualified safety
professionals that perform this function should have training and field experience that includes methods
used to control biohazards and knowledge of the design, application, and testing of biosafety cabinets.
Issues that may be considered include:
risk assessment;
selecting which kind of BSC is required and if it should be exhausted; and
assessment of the laboratory environment and the proper location of BSCs within it.
E.1.1 If there is a window in the laboratory, it should remain closed at all times. Cabinets should not be
located where room ventilation air inlets blow across the front opening or onto the exhaust filter.
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E.2.2
hazard identification;
exposure assessment;
dose-response assessment; and
risk characterization, and risk management (job analysis)2.
investigator/scientist;
laboratory staff;
animal care staff when appropriate;
animal veterinarian when appropriate; and
occupational health & biosafety professionals.
The information contained in this Annex is not part of this American National Standard (ANS) and has not been
processed in accordance with ANSIs requirements for an ANS. Therefore, this Annex may contain material that has
not been subjected to public review or a consensus process. In addition, it does not contain requirements necessary
for conformance to the Standard.
Songer, J.R. 1995. Laboratory safety management and the assessment of risk, p. 257-277. In D.O. Fleming, J.H.
Richardson, J.J. Tulis, and D. Vesley (ed.), Laboratory Safety: Principles and Practices, 2nd ed. ASM Press,
Washington, DC.
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E.2.3
E.2.4
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E.2.7
virulence;
infectious dose;
route of infection (portal of entry);
toxigenicity;
agent's host range;
if the agent is endemic or exotic to the environment it is in;
availability of effective preventive measures; and
availability of effective treatment.
E.2.6
animal hazards;
agent/pathogen/recombinant hazards;
chemical hazards; and
radiological hazards.
E.2.5
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E.2.8
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Assessment Level
Decrease<
>Increase
>>>
Unknown
>>>>
<<<
Culture procedure
>>>
Concentration procedure
>>>>>>
Animal/non-shedder
<<<
Animal/shedder
>>>>>>
>>>>>>
Mucous membrane
>>>
Parenteral
<<<
Other
<<<
Disease Severity
Moderate
>>
Severe
>>>
Life threatening/lethal
>>>>>>>>
Disease Prophylaxis
None
>>>>>>>>
Vaccine
<<
Immune globulin
<<<
Antibiotics
<<<
Antivirals
<<<
Other Factors
E.3
Livestock pathogen
>>>
Poultry pathogen
>>>
E.3.1 Selecting the proper BSC should be done in two stages; first, select the proper class and type of
cabinet required, then decide on the size of the cabinet and options that are needed. The various
configurations of Class II BSCs are shown in figures E2, E4 and E5. Deciding which class and type is
appropriate can be accomplished by answering the following five questions.
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If all that is needed is product protection, then a Clean Bench, which is not a BSC, may be the unit of
choice. Clean Benches use High Efficiency Particulate Air (HEPA or ULPA) filter(s) to remove particulates
from room air. This filtered, particulate-free air then flows through an enclosed work area, in a horizontal
or vertical direction. These devices bathe the materials inside in filtered air, and then the air is typically
discharged into the laboratory. While these devices protect the product from airborne contaminants, any
aerosol generated in the work area will be discharged into the laboratory. As such, they cannot be used
with toxic or biohazardous materials.
For personnel and environmental protection only, the Class I enclosure offers a simple and economical
solution. Room air sweeps around the operator and through the work area. This contaminated air is then
HEPA or ULPA- filtered and discharged into the laboratory or exhausted outside of the building via an
exhaust system. The Class I will protect the operator and the lab, however, because room air constantly
washes over the work area, the product is exposed to airborne contaminants.
Personnel, environmental, and product protection can be had most efficiently by a Class II Biosafety
Cabinet. The inflow of air around the operator provides personnel protection. HEPA- or ULPA-filtered air
flowing downward through the work area provides product protection, and protects the laboratory from
biohazardous particulates.
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E.3.1.2 What are all of the different types of work to be done in the cabinet?
One of the most difficult tasks in selecting a BSC is trying to foresee all the different types of work that will
be taking place in it. It is critical to decide what things need protection, both now and in the future. All too
often users purchase a Clean Bench or Class I device for current applications, only to find these devices
are unsuitable as their work requirements change.
E.3.1.3 What types and quantities of chemical vapors will be generated in the BSC?
As important as the preceding question, the user must also foresee the types and quantities of chemical
vapors that will be generated in the cabinet. Because chemical vapors can freely pass through HEPA or
ULPA filters, both Class I and Class II BSCs must be exhausted out of the laboratory when used with
these types of chemicals. For the Class II BSCs, Types B1 and B2 must be hard ducted to an external
exhaust system in order to operate properly; Types A1 and A2 can be converted to operate in either a
ducted or recirculating mode, depending on the users requirements. The airflow patterns of Types A1,
A2, B1 and B2 Biosafety Cabinets are shown in figures E2, E4 and E5, respectively.
E.3.1.4 If the unit requires an exhaust system, is there an appropriate location for the cabinet and
its ductwork?
If a BSC is going to recirculate its HEPA- or ULPA-filtered air back into the laboratory, then the user has
some freedom as to where the unit can be installed, provided it is out of major traffic areas, and there are
no other air handling devices in the area, as shown in figure E1.
When connected to a hard ducted exhaust system, however, the location of the cabinet becomes
dependent on the location of the exhaust system. The exhaust duct must be placed so it can penetrate
ceilings and floors without disturbing other ventilation or plumbing systems. The exhaust system must
also be designed to minimize excessive lengths and elbows. The exhaust system configurations of Type
A and Type B BSCs are shown in figures E3 and E6, respectively. Hard ducting Type A cabinets is not
acceptable and shall only be exhausted through a properly designed and fitted exhaust canopy.
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E.3.1.5 If the volume of air being removed by the BSCs exhaust system is reduced, or eliminated,
due to malfunction, what is its effect on BSC performance, and what is preferred by the user?
For a Type A BSC fitted with a properly designed canopy connection, reduction or elimination of the
exhaust air should not significantly affect the airflow patterns within the BSC. Personnel and product
protection of the BSC will remain unchanged; however, chemical vapors generated in the BSC will be
exhausted into the laboratory via the openings or slots in the canopy.
For a Type B BSC, any reduction or elimination of the exhaust air will directly impact the inflow velocity,
and thus the personnel protection offered by the BSC. Reduction of exhaust airflow will reduce the inflow,
jeopardizing personnel protection. Loss of the exhaust airflow will eliminate the inflow of air into the front
of the BSC, negating personnel protection, and allowing materials in the work area of the BSC to escape
into the laboratory.
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Airflow Pattern
Air Recirculation
Inflow
Downflow
Biological
Containment
Exhaust System
Exhaust System
Type
Exhaust System
Function
Exhaust System
Volume
Exhaust System
Negative Static
Pressure at BSC
Exhaust System
Reserve
Capacity
Cabinet Flexibility
Cabinet Cost
Installation Cost
Operation Cost
Electrical Cost
(BSC Only)
Tempered Air
Loss
Equal to Type B1
Slightly greater than Type B2
If recirculating in lab; none. If canopy-connected,
typically 100 CFM/foot of BSC width or less.
Equal to Type B1
Slightly greater than Type B2
If recirculating in lab; none. If canopy-connected,
typically 100 CFM/foot of BSC width or less.
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Airflow Pattern
Air Recirculation
Inflow
Downflow
Biological
Containment
Exhaust System
Exhaust System
Type
Exhaust System
Function
Exhaust System
Volume
Exhaust System
Negative Static
Pressure at
BSC
Exhaust System
Reserve
Capacity
Cabinet Flexibility
Cabinet Cost
Installation Cost
Operation Cost
Electrical Cost
(BSC Only)
Tempered Air
Loss
None
Minimum 100 FPM Average
Varies by model, typically 50-80 FPM average
All NSF-Listed BSCs must pass the same
Biological Containment Tests.
Required.
Should have dedicated ductwork and exhaust
blower for each BSC.
Must pull exhaust air through the Cabinets
Exhaust HEPA or ULPA filter and then through
ductwork.
B2 exhausts 100% or more air than any other
Type.
Typically 1.5 inches H2O minimum.
Equal to Type A
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E.3.2
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BSC size
Having decided which class and type of BSC is the best, the user should now decide on the size of the
unit and its options. Typical workspace widths are three, four five and six feet. Outside dimensions are
approximately 3.5, 4.5, 5.5 and 6.5 feet. In deciding which size is best, the user should mark out an area
of benchtop equal to the inside (work area) dimensions of the model they are interested in. The user(s)
should perform several "dry runs" of their procedures in this area. If the user can work in this defined
space, than the cabinet is the proper size, if not, the user may want to try working in the dimensions of the
next larger model. If the user does decide on a larger model, however, be sure that the BSC can be
transported to and installed in the laboratory through the existing freight elevators, hallways and doors. It
is important to remember that BSC widths typically refer to the internal work area. The external width of
the BSC may be significantly wider.
E.3.3
BSC options
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Most BSCs have electrical outlets installed in the work area as standard equipment. Specialized outlets,
such as Ground Fault Circuit Interrupters (GFCIs) should be installed and tested by the cabinet
manufacturer.
Typically the outlets in the work area are limited in their amperage rating. This is due to the amperage
requirements of the BSCs motor, lighting, and other electrical components.
Variations in line voltage from the laboratory wall outlet may affect the cabinet airflows. A voltage
regulator may need to be installed in order to reduce the potential of variations in airflows.
E.3.3.3 Ultraviolet lighting
Germicidal (or UV) Lamps are often installed as an adjunct to surface disinfection. UV lighting is not
recommended in Biosafety cabinetry. While their usefulness is a subject for debate among users and
manufacturers, they should be installed and tested by the manufacturer during assembly of the unit.
E.3.3.4 IV bar
Because intravenous (IV) bars or rods have a significant impact on the airflows in the work area, always
use the IV bar recommended by the manufacturer.
E.3.3.5 Base stands
Base Stands or supports should also be considered at the time of specification. Some models of cabinets
can weigh up to 900 pounds (408 Kg). The BSC must be attached to a manufacturer recommended base
stand or a structure rated to support the unit's weight. All base stands have a maximum height specified
by the manufacturer to prevent overturning of the BSC; this maximum should never be exceeded.
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E.4
E.4.1 Consultation
Investigators should consult with a biosafety officer or qualified safety professional and request a risk
assessment of the proposed investigation to ensure that an appropriate BSC is used for the work.
Purchase of NSF 49 listed Class II biosafety cabinets is recommended, but alternative containment
equipment may be suggested for special tasks.
E.4.2 Site assessment
The investigator should thoroughly examine the intended installation site to ensure it will meet the
requirements for proper cabinet operation.
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The cabinet should be located away from traffic patterns, doors, fans, ventilation registers, fume hoods
and any other air-handling device that could disrupt its airflow patterns. All windows in the room should
be closed. Figure E1 shows the preferred location for the cabinet.
E.4.2.2 Clearances
BSCs not connected to an exhaust system should have at least 6 inches (15 cm) clearance from any
overhead obstructions when the cabinet is in its final operating position, to allow for testing of the Exhaust
HEPA/ULPA filter. A clearance of at least 6 inches (15 cm) should be maintained on both sides of the
cabinet, as well as 12 inches (30 cm) behind the unit, to allow for service operations if necessary.
E.4.2.3 Exhaust requirements
If the BSC is to be connected to an exhaust system, first examine the location to ensure that it is
compatible with the cabinets exhaust outlet. The area directly above the cabinets exhaust outlet should
be clear of structural elements, water and utility lines, or other fixed obstructions. There should be enough
clearance to allow for the passage of a 10 inch (25 cm) or 12 inch (30 cm) diameter duct. Avoid cabinet
locations that require either an elbow directly on top of the cabinets exhaust connection or an excessive
number of elbows to clear other items.
E.4.2.4 Electrical requirements
The electrical outlet that the BSC plugs into should have a dedicated circuit breaker. This will prevent the
accidental shutdown of the cabinet, should another device overload the circuit.
Some larger cabinet models, when operated at 115 Volts, will require a circuit rated for 20 Amp service.
As the electrical plugs and sockets for 115 Volt, 15 and 20 Amp ratings are different configurations; the
user should confirm that the site outlet socket matches the BSC plug
NOTE - Some cabinets do not operate properly when connected to a ground fault circuit interrupter (GFCI).
Consult with the BSC manufacturer about compatibility of their model with a GFCI outlet, if one is present.
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Roof exhaust systems serving biosafety cabinets should have a stack that extends straight upward at
least 10 ft (3 m) above the roof surface or have a stack with a smaller diameter trailing end to produce
higher velocity flow to avoid re-entrainment by the building, and should be increased in elevation when
necessary to avoid the influence of surrounding structures. Raincaps or any other structure that deflects
the straight upward flow of the discharged air should be avoided. No precipitation can enter the stack
when air is being exhausted at normal stack velocities. To take care of precipitation during periods when
system is shut off, a 1 in (2.5 cm) hole can be drilled in the lowest point of the fan casing and the water
allowed to drain onto the roof. It is recommended that roof exhaust fans be energized by direct-connected
electric motors to avoid failures caused by slipping and breaking of belts. Another advantage of directconnected fans is the ability to use the motor non-function to activate an alarm in the laboratory, whereas
when a malfunctioning belted fan is employed, the motor can be operating when the fan is idle. A diagram
illustrating a recommended roof exhaust facility is shown in Annex E, figure E7.
E.4.3 Pre-purchase checklist
The investigator should notify building management to arrange for a feasibility assessment of laboratory
alterations and BSC location. The investigator and biosafety officer or qualified safety professional should
discuss the following points about the BSC and its delivery:
get a written price quote for the entire package, including the BSC Model number, optional
equipment, canopy exhaust connection, etc. Work out the details about shipping and delivery
with the manufacturer's representative at the time of purchase;
determine the costs for shipping and delivery because there may be additional costs
depending on the location and level of difficulty of delivery;
ensure that the sales representative clarifies in writing what is included in "shipping and
delivery". Does it include delivery of the BSC to the receiving dock of the building or to the
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laboratory? Does it include BSC set-up in the work area, and removal of cartoning/crating
materials?
if not covered in the purchase price, the customer will have to get facility personnel, or hire
moving contractors to uncrate and move the BSC;
ensure the corridor pathways are clear for delivery to the laboratory,
will the BSC travel around sharp, narrow corridors and corners?
the moving contractor should be advised that the BSC shall be lifted onto its stand or leg
extensions (working position) with a hydraulic lift;
E.5
responsibility for removal and proper disposal of all packing materials must be established.
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Inspection
E.5.1 When the BSC arrives, inspect it carefully. Compare the invoice with the delivered equipment.
Check for any damage or missing materials and report them immediately to the proper carrier and the
BSC supplier regardless of how insignificant they may first appear. Be careful of sharp crating material
and let the loading dock personnel help check for damage.
E.5.2 Arrange for certification after the BSC is installed. Building operations personnel may be needed to
connect the BSC to laboratory plumbing, electrical, and supply/exhaust air ventilation systems.
E.6
E.6.1 It is a common practice to move permanently installed BSCs to other locations within a laboratory or
to other laboratories. Despite the apparent simplicity of the job, there are certain conditions that must be
met prior to moving this equipment. BSCs should not be moved without consultation with a biosafety
officer or qualified safety professional.
E.6.2 Existing BSCs and ancillary equipment, such as canopy connection exhaust ducting, gas, electric
and vacuum connections, should be cleared for maintenance by a biosafety officer or qualified safety
professional prior to disassembly. Depending on circumstances of the move, (i.e., cabinet use, new
location, etc.), BSCs may be required to be space decontaminated. After a BSC is moved, it should be
certified according to applicable performance standards.
E.7
Lifespan of BSCs
The current lifespan of a Biosafety Cabinet is approximately 15 years. Use of modern day Biosafety
Cabinets (BSCs) began in the early 1970s with BSCs that were manufactured to the NIH-03-112C
Standard and subsequently the NSF/ANSI 49. BSCs manufactured in the 70s, 80s and early 90s have
provided over 15 years of service. Several considerations should be made of BSCs in this age group.
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Will the BSC need extensive service? (i.e. HEPA/ULPA filter replacement, blower/motor
replacement, will the electrical wire harnesses need replacement? etc.).
Can an older BSC be commissioned after it has been in storage or purchased as a resale?
Will original test reports be available or will the BSC be commissioned to current NSF
Standards?
After 15 years, replacement parts may or may not be available due to electrical or mechanical changes at
the factory or industrial part suppliers. For example, magnetic ballasts and T12 fluorescent bulbs will no
be available after the year 2010. In addition, todays BSCs have evolved through the years with many
improvements in containment, ergonomics, serviceability, and energy efficiency. That should be
considered in a repair versus replacement decision.
E.8
Decommissioning process
E.8.1 No biosafety cabinet should be sent to a landfill or a recycling facility as a BSC, it should be
disassembled per requirements contained in this section.
E.8.2. Decontamination and PPE
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E.8.2.1 After a review of the BSC hazard use, the cabinet may be considered chemically contaminated
and requiring special decontamination procedures, not the standard gaseous sterilization. Follow
paragraph E.10.2.3.
E.8.2.2 All decommissioned BSCs used with pathogens should be space decontaminated.
E.8.2.3 BSCs to be decommissioned that were used with chemical agents should have a hazard review
made to determine whether special decontamination practices and PPE should be followed.
E.8.2.4 For those BSCs used with biological agents that may not be inactivated via formaldehyde, the
filters should be incinerated and 10% bleach or other appropriate disinfectant applied to all remaining
contaminated surfaces. Obtain prior approval of the Facility Safety Officer.
E.8.2.5.1 PPE should be used as directed by the Facility Safety Officer or the biosafety safety officer.
E.8.3 Metal parts
E.8.3.1 All metal parts of less than 30 pounds (13 kg) per item should be removed from the lab and taken
to an appropriate metal recycling container.
E.8.3.2. Metal parts in excess of 30 pounds (13 kg), including the unit chassis, should be taken to a
designated area in the facility to be picked up by a commercial recycling vender.
E.8.4 Glass windows
E.8.4.1 All glass safety windows and sashes should be taken to the designated glass container. Remove
all parts that are not press fit or glued to the glass edges or surfaces.
E.8.5 Wiring
E.8.5.1 All accessible wiring should be taken to a wiring recycling container.
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E.8.9.2 HEPA/ULPA filters may be placed in heavy plastic bags, such as those used to bag-out filters
from contaminated filter housings. The bagged filters can be chemically decontaminated in situ by cutting
small holes in the bag and delivering appropriate disinfectant or neutralizing agent by inserting a gardentype spray through the hole and spraying the filter media. The holes can be sealed with duct tape and
shipped to an incinerator or sanitary landfill. This chemical method may be appropriate for filters
containing agents (i.e. toxic chemicals) that cannot be inactivated by the usual space decontamination
procedures.
E.8.9.3 Decontaminated HEPA/ULPA filters may be safety buried in a sanitary landfill because they no
longer pose a hazard.
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