biosafety level and biosafety cabinets
TRANSCRIPT
Biosafety LEVELS & Biosafety LEVELS & BIOSAFETY Cabinets BIOSAFETY Cabinets
Bio safety Levels Air Filtration in Biosafety cabinets Standards Hood , Laminar flow & Bio safety Cabinets Classification –Bio safety Cabinets
TopicsTopics
Biosafety LevelsBiosafety Levels
Bio Safety Level (BSL)-I:Well-characterized agents not known to consistently cause disease in healthy adult
humans, and of minimal potential hazard to laboratory personnel and the Environment.
Standard practices required:
frequent hand washing door that can be kept closed when working limits on access to the lab space when working no eating, drinking, storage of food in laboratory care to minimize splashes and actions that may create aerosols (tiny droplets) decontamination of work surfaces after every usePrimary Safety Barriers- Not Required
Biosafety LevelsBiosafety Levels
Bio Safety Level (BSL)-II:• Suitable for work involving agents of moderate potential hazard to personnel
and the environment.
• Generally associated with human disease
Safety Equipment (Primary barriers):
• Class I or II Bio safety Cabinets or other physical containment devices (eg…. Aerosol tight lid in Centrifuges) are used
• Personnel Protection Equipment: Laboratory coats, gloves, face protection as needed
Facilities (Secondary barriers):
• Provide lockable doors for facilities that house restricted agents
• Locating new laboratories away from public areas.
• Furniture used in laboratory work should be covered with a non-fabric material that can be easily be decontaminated.
• An eye wash station is readily available.
Biosafety LevelsBiosafety Levels
Bio Safety 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 the inhalation route.
Safety Equipment (Primary barriers):
• Class I or II Bio safety Cabinets
• Personnel Protection Equipment: Laboratory coats; gloves; face protection as needed
• Facilities (Secondary barriers):
• The laboratory has special engineering and design feature . The exhaust air from the laboratory room is discharged to the outdoors
• The ventilation to the laboratory is balanced to provide directional airflow into the room
Biosafety LevelsBiosafety Levels
Bio Safety Level (BSL)-IV: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 Bio safety Cabinets
or Class I or II Bio Safety Cabinets in combination with full-body, air-supplied, positive pressure personnel suit.
Facilities (Secondary barriers):
BSL-3 plus:• Separate building or isolated zone• Dedicated supply and exhaust and decontamination systems
Biosafety LevelsBiosafety Levels
Air Filtration in Biosafety cabinetsAir Filtration in Biosafety cabinets
•High efficiency particulate air (HEPA) filters•Ultra low particulate air (ULPA) filters
Air Filtration in Biosafety cabinetsAir Filtration in Biosafety cabinets
Variations in HEPA filter efficiency from 99.95 % to 99.99 % are usually due to manufacturing techniques.
Depending upon its quality, a HEPA filter is able to trap from 9,995 to 9,999 of every 10,000 particles
An ULPA filter is able to trap from 99,995 to 99,999 of every 100,000 particles
ULPA - this is at least 10 times better than HEPA filtration !!!
International Standards on Biosafety CabinetInternational Standards on Biosafety Cabinet
Why a standard ?Why a standard ?
International Standards on Biosafety CabinetInternational Standards on Biosafety Cabinet
International Standards are mainly issued by two Organisations: International Standard Organisation (ISO), based in Geneva (Switzerland),Comitee Europeen de Normalisation (CEN) based in Brussels (Belgium).
These 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.
Both construction and testing of the cabinet are covered
International Standards on Biosafety CabinetInternational Standards on Biosafety Cabinet
Standards:BS-5726 (U.K.)NF X44-201 (France)DIN 12950 (Germany) Now Replaced by EN 12469
EN 12469
European Standards on Design, Construction & Testing of Bio safety Cabinets
In addition to comply DIN 12980 for safety handling of cytotoxic drugs
NSF-49 (National Sanitation Foundation) In the USA the NSF-49, was one of the first standards on this subject and was the reference point for a lot of manufacturers. NSF is an independent organisation that works as neutral agency to help on the problems that could affect to public health and environment protection.
Was published in 1976.
Difference between Hood and Safety CabinetDifference between Hood and Safety Cabinet
Exhaust of vapors and aerosols from Laboratory to outside
No validatable product or personnel protection
Validatable personnel, product & environmental protection
Filters and blower(s) incorporated
HoodHood Safety CabinetSafety Cabinet
A fume hood is a ventilation device that is designed to limit exposure to hazardous fumes vapors or dust. A fume hood is typically a large piece of equipment enclosing five sides of a work area, the bottom of which is most commonly located at a standing work height.
Two main types exist, ducted and recalculating. The principle is the same for both types: air is drawn in from the front (open) side of the cabinet, and either expelled outside the building or made safe through filtration and fed back into the room.
Fume HoodFume Hood
Fume Hood
Only for Product Protection No Personnel or Environment Protection
Laminar FlowLaminar Flow
A. front openingB. sashC. supply HEPA filterD. blower
Vertical Laminar Flow
Laminar FlowLaminar Flow
A. front openingB. supply grilleC. supply HEPA filterD. supply plenumE. blowerF. Grille
Horizontal Laminar Flow
Classification of Bio Safety CabinetClassification of Bio Safety Cabinet
Biological Safety Cabinet
Class I Class II
Class III
Type A Type B
Type A I
Type A II
Type B I
Type B II
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class I: Personnel and Environment protection. Product is not protected.
Class II: Personnel, Product and Environment are protected.
Class III: Maximum protection to Personnel, Product and Environment.
Classification of Biosafety CabinetClassification of Biosafety Cabinet
A. Front openingB. SashC. Exhaust HEPA
FilterD. Exhaust plenum
Class I Biosafety Cabinets
This is a negative-pressure, ventilated cabinet usually operated with an open front.
All of the air from the cabinet is exhausted through a HEPA filter either into the laboratory or to the outside.
The Class I BSC is designed for general microbiological research with low- and moderate-risk agents.
Classification of Biosafety CabinetClassification of Biosafety Cabinet
A. front openingB. sashC. exhaust HEPA filterD. rear plenumE. supply HEPA filterF. blower
Class II Type A-I Biosafety Cabinets
It is designed with inward air flow to protect personnel, Product & Environment
HEPA-filtered downward vertical laminar airflow for product protection, and HEPA-filtered exhaust air for environmental protection
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Face Velocity 75 fpm
70% re circulated through HEPA Filter
30% Exhausted Through HEPA Filter
Cannot be used for Radio Nucleotides and Toxic Chemicals
Biosafety Levels 2 & 3
User, Product, & Environment Protection
Class II Type A-I Biosafety Cabinets
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class II Type A-II Biosafety Cabinets
A. front openingB. sashC. exhaust HEPA filterD. supply HEPA filterE. positive pressure plenumF. negative pressure plenum
Note: The cabinet exhaust needs to be connected to the building exhaust system.
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class II Type A-II Biosafety Cabinets
Downward Velocity 100 fpm
70% re circulated through HEPA
Filter30% Exhausted Through HEPA Filter
Can be used for Radio Nucleotides and Toxic Chemicals
Biosafety Levels 2 & 3User, Product, & Environment Protection
Under Negative Pressure to room
Exhaust Air is Hard Ducted
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class II Type B-I Biosafety Cabinets
A. front openingB. SashC. exhaust HEPA filterD. supply plenumE. supply HEPA filterF. BlowerG. negative pressure exhaust plenum Note: The cabinet exhaust needs to be
connected to the building exhaust system.
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class II Type B-I Biosafety Cabinets
Downward Velocity 100 fpm
30% re circulated through HEPA Filter
70% Exhausted Through HEPA Filter
Can be used for Radio Nucleotides and Toxic Chemicals (Low Levels / Volatility)
Biosafety Levels 2 & 3User, Product, & Environment Protection
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class II Type B-II Biosafety Cabinets
A. front openingB. SashC. exhaust HEPA filterD. supply HEPA filterE. negative pressure exhaust
plenumF. supply blower G. filter screen
Note: The carbon filter in the building exhaust is not shown. The cabinet exhaust needs to be connected to the building exhaust system
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class II Type B-II Biosafety Cabinets
Downward Velocity 100 fpm
No Re-circulation100% Exhausted Through HEPA Filter
Can be used for Radio Nucleotides and Toxic Chemicals
Biosafety Levels 2 & 3User, Product, & Environment Protection
Exhaust HEPA Filtered
Exhaust Hard Ducted out.
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class III Biosafety Cabinets
A. glove ports with O-ring for attaching arm-length gloves to cabinet
B. SashC. exhaust HEPA filterD. supply HEPA filterE. double-ended autoclave or pass-
through box
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.
Classification of Biosafety CabinetClassification of Biosafety Cabinet
Class III Biosafety Cabinets
This is a totally enclosed, ventilated cabinet
Gas-tight construction
Offers the highest degree of personnel and environmental protection from infectious aerosols as well as protection of research materials from microbiological contaminants.
Cytotoxic Drug Safety CabinetsCytotoxic Drug Safety Cabinets
Hepa filter exhaust #2
Hepa filter (pre-filter) #1
Laminar flow filter
Carbon filter exhaust #3 (option)Dedicated exhaust flow blower
All contaminated areas underNEGATIVE pressure
Dedicated Laminar flow blower
70% re circulated HEPA filtered laminar flow Provides sample protection
30% inflow provides operatorSafety barrier
Can you see the problems ?Can you see the problems ?
Window
Air vent
Ceiling clearanceor wall clearance
Front Venting ExhaustBEWARE
Location In LabLocation In Lab
Location A, E and F are well selected.As well influencing
air flows through the Laboratory
personnel traffic is avoided.
Location B is often influenced from air flows in the Room.
Location C is influenced from personnel traffic
and Room air flows.
Location D is also very often influenced from personnel traffic and air flows.
Safety Cabinets should only be placed in quiet areas!
Only validated tests can show placement in the
laboratory is correct.
In this instance the tests are invaluable!