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Biosafety Levels Specifications

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67 views12 pages

Biosafety Levels Specifications

Uploaded by

anisamaponga
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Biosafety Levels

Biosafety Cabinet Level II Specifications


Class II cabinets are designed for personnel, product and environmental protection. All class II
BSCs are designed for work involving Biosafety Level-1, -2, and -3 organisms. Class II BSCs are
divided into type A and B cabinets based on construction, airflow, and exhaust systems.

Biosafety Cabinet Level III General requirements


This is a totally enclosed, ventilated cabinet which offers the highest degree of personal and
environmental protection from infectious aerosols as well as protection of research materials
from microbiological contaminants.

All penetrations are sealed “gas tight”. Supply air is HEPA-filtered and exhaust air passes through
two HEPA filters. Air flow is maintained by a dedicated exhaust system exterior to the cabinet,
which keeps the cabinet interior under negative pressure (about 124.5 Pa). Access to the work
surface is by means of heavy duty rubber gloves, which are attached to ports in the cabinet. The
Class III BSC should have an attached pass-through box that is sterilizable and is equipped with
HEPA-filtered exhaust. The Class III cabinet may be connected to a double-door autoclave used
to decontaminate all materials entering or exiting the cabinet. Several glove boxes can be joined
together to extend the work surface. Class III BSCs are suitable for work in Biosafety Level 3 and
4 laboratories.

Materials are passed into the cabinet through a dunk tank, that is accessible through the cabinet
floor, or double-door pass-through box (e.g., autoclave) that can be decontaminated between
uses. The same process is reversed to take items out of the cabinet. Both supply and exhaust air
are HEPA filtered on a Class III cabinet and the exhaust air must pass through two HEPA filters, or
a HEPA filter and an air incinerator, before discharge to the outside.

Certification of hard-duct connected BSCs is more time-consuming than that for BSCs that
recirculate air to the room or which are thimble-connected.
Figure 1: Schematic representation of a class III biosafety cabinet (glove box) without dunk tank.

Figure 2: Schematic representation of a class III biosafety cabinet (glove box) with a dunk tank.
A- Glove ports with O-ring for attaching arm-length gloves to cabinet
B- Sash
C- Exhaust HEPA filter
D- Supply HEPA filter
E- Double-ended autoclave or pass-through box
F- chemical dunk tank

Note: A chemical dunk tank may be installed which would be located beneath the work surface of
the BSC with access from above. The cabinet exhaust needs to be connected to the building exhaust
system. Connection of cabinet exhaust to an independent building exhaust air system is required.

Air Filtration in Biosafety cabinets


There are two types of filters, high efficiency particulate air (HEPA) filters and ultra-low particulate
filers (ULPA). HEPA filters are able to trap 9,995 to 9,999 of every 10,000 particles, and are used in
BSC Class III.

Biosafety cabinet air connections


BSCs class II and III are hard-ducted, i.e. firmly connected without any openings, to the building
exhaust system or, preferably, to a dedicated exhaust duct system. The building exhaust system
must precisely matched to the air flow requirements specified by the manufacturer in both volume
and static pressure. Certification of hard-duct connected BSCs is more time-consuming than that for
BSCs that recirculate air to the room or which are thimble-connected.

International Standards
Biological safety cabinets are generally required to comply with that country or region's standards.
International Standards are mainly issued by two organizations. International Standards Association
(ISO), based in Geneva, Switzerland, and the Committee Europeen de Normalisation (CEN) based in
Brussels, Belgium.

These two standards replace all other local standards on the same subject. The aim of the standards
is to construct a mechanism to provide manufacturer and user of a common site to specify technical
specifications and features.

Some standards used include:

ISO 15190:2020(en) Medical laboratories — Requirements for safety

Maintenance and service


There are specific field test requirements for class II BSC's. Responses are still being waited on. The
United States' base for field testing is NSF49; Europe relies on EN12469; and Australia has the
AS1807 series of test methods (referenced within AS2252.2). The field test requirements may
include:

Air velocity within the work zone


Air barrier testing (barrier between operator and product; some standards utilise inward velocity
testing instead)
1. Filter integrity (leak testing or the amount of aerosols that a filter allows to pass through it)
2. Particle counting within the work zone
3. Gas tightness
4. Leak testing of the work zone (work zone integrity testing)
5. Illuminance within work zone
6. UV light effectiveness
7. Sound level

In general terms, a regular service maintenance schedule may include the following tasks:

Airflow and filter capacities are verified. The filters have a limited lifespan, determined by the air
quality within the laboratory space, the amount of particles & aerosols generated inside the BSC
work zone, and the volume of air passing through the filters. As these filters load, the internal fan is
required to do more work to push/pull the same volume of air through them. Newer cabinets
measure the airflow constantly and self-compensate fan performance to ensure constant volumes of
air moving through the filters and the cabinet. However, self-adjusting cabinets should be cross-
verified by calibrated instruments to ensure that performance is maintained to the correct levels. If
the flow drops below desired performance, an audio and visual alarm will alert the operator.
Changing the filter should be limited to trained persons as the filter is potentially contaminated. This
can be done either after the cabinet has been decontaminated using a gaseous procedure (using
formaldehyde, chlorine dioxide, or vaporized hydrogen peroxide) or a "bag-in/bag-out" procedure.

UV lights are checked and changed. UV lights decrease in power over time, resulting in diminished
disinfection of the working area.

Summary of requirements
Biosafety Level (BSL) III:
Applicable where work is done with indigenous or exotic agents which may cause serious or
potentially lethal disease as a result of exposure by inhalation.

Safety Equipment (Primary barriers):


 Class II (Type B2) Biosafety Cabinets
 BLS 3 Lab is needed
 Personal Protection Equipment : Laboratory coat (solid front gown), face mask, gloves, face
protection as needed

Facilities (Secondary Barriers):


 The laboratory needs special engineering and design feature. The exhaust air from the
laboratory room is discharged to the outdoors and never recirculated.
 The ventilation to the laboratory is balanced to provide airflow into the room.
 A hands-free sink and eyewash to be available near the exit
 Entrance to the laboratory is through two sets of self-closing and locking doors
 This lab should have its own equipment
Biosafety Level (BSL) IV:
For dangerous/exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab
infections or related agents with unknown risk of transmission.

Safety Equipment (Primary barriers):


 All procedures conducted in Class III Biosafety Cabinets or Class I or II Biosafety cabinets in
combination with full-body, air-supplied, positive pressure personal suit.
 Change of clothing before entering the laboratory and shower upon exiting are a usual
laboratory practice.
 An area for decontamination of materials before exiting

Facilities (Secondary Barriers):


BSL-3 plus:

 Separate building or isolated, restricted zone


 Dedicated supply and exhaust and decontamination systems

Figure 3: A CDC laboratory personnel dons an older-model positive-pressure suit before entering one
of the CDC's earlier BSL-4 labs.

Where to purchase Type III Biosafety cabinets.

In Zimbabwe, Ideal Medical Solutions, F6, First Floor, Travel Plaza. Cnr Mazoe & Chinamano Avenue.
Harare, Harare, Zimbabwe. And LabLad at
Online and probable suppliers

Name of product Supplier Location URL


Baker - Model Class Baker Company Online https://www.environmental-
III - Specialized expert.com/products/baker-
Biological Safety model-class-iii-specialized-
Cabinets biological-safety-cabinets-701998
ISOGARD® Isogard Online https://www.environmental-
Class III Glovebox. expert.com/products/isogard-
Designed to Handle model-class-iii-biosafety-glove-
Hazardous box-701981
Microbiological
Agents or
Pharmaceutical
Potent
Compounds.
Lamsystems - Lamsystems Online https://www.environmental-
Model BMB-III- expert.com/products/lamsystems-
Laminar-S Protect model-bmb-iii-laminar-s-protect-
VIS-A-VIS - vis-a-vis-biological-safety-
Biological Safety cabinets-683707
Cabinets
ISOGARD MODELS
BSC By LAMSYSTEMS, Model Protect Details
Model Vis A Vis by LAMSYSTEMS

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