biosafety level 2 is similar to level 1 and is suitable...

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96/405 Biosafety Level 2 (BL-2, P-2) BIOSAFETY LEVEL 2 is similar to Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. It differs in that: Laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists Access to the laboratory is limited when work is being conducted Extreme precautions are taken with contaminated sharp items Certain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment. 96/626 97/405 Biosafety Level 2 As in BSL-1 With emphasis on : Gloves Mechanical pipetting Attention to sharps Standard Microbiological Practices 97/626

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Page 1: BIOSAFETY LEVEL 2 is similar to Level 1 and is suitable ...elearning.kocw.net/KOCW/document/2015/handong/kwakjinhwan/5.pdf · Biosafety manual specific to lab Training with annual

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Biosafety Level 2 (BL-2, P-2)BIOSAFETY LEVEL 2 is similar to Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. It differs in that:

Laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientistsAccess to the laboratory is limited when work is being conductedExtreme precautions are taken with contaminated sharp itemsCertain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment.

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97/405

Biosafety Level 2

As in BSL-1

With emphasis on :GlovesMechanical pipettingAttention to sharps

Standard Microbiological Practices

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Biosafety Level 2

Immunization or antibiotic treatment is available

Extreme precaution with contaminated needles or sharp instruments

Examples:Human body fluids/particularly when visibly contaminated with blood (Bloodborne pathogens)Measles virusSalmonellaeToxoplasma spp.Hepatitis B virusE. coli, pathogenic strainsAdenovirusHerpes simplex virusChicken pox

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Biosafety Level 2

Needles & Sharps Precautions

Special Practices

DON’T Break, bend, resheath or reuse syringes or needles

DOUse sharps containers

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Biosafety Level 2

DO Use Plasticwares

Special Practices

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Biosafety Level 2

Policies and procedures for entry

Biohazard warning signs

Biosafety manual specific to lab

Training with annual updates

Special Practices

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Biosafety Level 2

Use leak-proof transport containersSpecial Practices

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Biosafety Level 2

ImmunizationsBaseline serum samples

Special Practices

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Decontaminate work surfaces

Report spills and accidents

No animals in laboratories

Biosafety Level 2

Special Practices

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Biosafety Level 2

BSL-1 PLUS:Use biosafety cabinets (class II) for work with infectious agents involving:

Aerosols and splashesLarge volumes High concentrations

Safety Equipment (Primary Barriers)

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Biosafety Level 2

Class II Biosafety Cabinets

Airflow

Safety Equipment (Primary Barriers)

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Biosafety Level 2

Supervision

Supervisor is a competent scientist with increased

responsibilities

Limits access if immuno-compromised

Restricts access to immunized

Lab Personnel

Aware of potential hazards

Proficient in practices/techniques

Special Practices

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Biosafety Level 2 (BL-2, P-2)

When the infectious agent(s) in use in the laboratory require special provisions for entry(e.g., immunization), a hazard warning sign incorporating the universal biohazard symbol is posted on the access door to the laboratory work area.

Special Practices

Escherichia coliPrecautions:Must use Eye protection, lab coat, glovesOnly use under BSC

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Biosafety Level 3 (BL-3, P-3)

BIOSAFETY LEVEL 3 is applicable to for work with infectious agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route.All procedures involving the manipulation of infectious materials are conducted within biological safety cabinets or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment. The laboratory has special engineering and design features.

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Biosafety Level 3

Class 3 agents are associated with serious or lethal human diseases for which preventative or therapeutic interventions may be available (high individual risk but low community risk)

Francisella tularensisHuman immunodeficiency virusHistoplasma capsulatumMycobacterium tuberculosisSt. Louis encephalitis virusCoxiella burnetii

Aerosol is a common route of transmission, and increases the risk potential for these agents

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Biosafety Level 3

Safety Equipment (Primary Barriers)

BSL-1 and 2 Safety Equipment PLUS:

BSC class II or III to manipulate infectious material

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Biosafety Level 3

Safety Equipment (Primary Barriers)

BSL-1 and 2

Safety

Equipment

PLUS:

Respiratory

protection

may be

indicated

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Biosafety Level 3

BSL-1 and 2 Facilities PLUS:

Separate building or isolated zone

Double door entry

Directional inward airflow

Single-pass air

Laboratory Facilities (Secondary Barriers)

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Biosafety Level 3

BSL-1 and 2 Facilities PLUS (cont.):

Enclosures for aerosol generating

equipment

Room penetrations sealed

Walls, floors and ceilings are water

resistant for easy cleaning

Laboratory Facilities (Secondary Barriers)

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A ducted exhaust air ventilation system is provided.

This system creates directional airflow that draws air from "clean" areas into the laboratory toward "contaminated" areas.

The exhaust air is not recirculated to any other area of the building, and is discharged to the outside with filtration and other treatment optional.

The High Efficiency Particulate Air(HEPA)-filtered exhaust air from Class II or Class III biological safety cabinets is discharged directly to the outside or through the building exhaust system.

Biosafety Level 3

Laboratory Facilities (Secondary Barriers)

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Biosafety Level 3

BSL-1 and 2 Facilities PLUS:Vacuum lines protected

Laboratory Facilities (Secondary Barriers)

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Biosafety Level 3

As in BSL-1 and BSL-2

Standard Microbiological Practices

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Biosafety Level 3

Supervision

Supervisor is a competent scientist

experienced working with agents

Establishes criteria for entry

Restricts access

Develops policies/procedures

Trains lab personnel

Special Practices

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Biosafety Level 3

Lab Personnel

Strictly follow guidelines

Demonstrate proficiency

Receive appropriate training

Report incidents

Participate in medical surveillance

Special Practices

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Biosafety Level 3 (BL-3, P-3)

Laboratory doors are kept closed when experiments are in progress.

When infectious materials or infected animals are present in the laboratory or containment module, a hazard warning sign, incorporating the universal biohazard symbol, is posted on all laboratory and animal room access doors.

Cultures, tissues, or specimens of body fluids are placed in a container that prevents leakage during collection, handling, processing, storage, transport, or shipping.

All potentially contaminated waste materials (e.g., gloves, lab coats, etc.) from laboratories or animal rooms are decontaminated before disposal or reuse.

Special Practices

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Biosafety Level 4 (BL-4, P-4)

BIOSAFETY LEVEL 4 is required for work with dangerous and exotic agents which pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease. Members of the laboratory staff have specific and thorough training in handling extremely hazardous infectious agentsAccess to the laboratory is strictly controlled by the laboratory director.

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Biosafety Level 4 (BL-4, P-4)

The facility is either in a separate building or in a controlled area within a building, which is completely isolated from all other areas of the building.Within work areas of the facility, all activities are confined to Class III biological safety cabinets, or Class II biological safety cabinets used with one-piece positive pressure personnel suitsventilated by a life support system. The Biosafety Level 4 laboratory has special engineering and design features to prevent microorganisms from being disseminated into the environment.

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Biosafety Level 4

Class 4 agents are likely to cause serious

or lethal human disease for which

preventive or therapeutic interventions are

not usually available (high individual risk

and high community risk)

Ebola virus

Herpes B virus (Cercopithecine)

Lassa fever virus

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Biosafety Level 4

The Biosafety Level 4 facility consists of either a separate building or a clearly demarcated and isolated zone within a building. Outer and inner change rooms separated by a shower are provided for personnel entering and leaving the facility. Walls, floors, and ceilings of the facility are constructed to form a sealed internal shell which facilitates fumigation and is animal-proof and insect-proof. The internal surfaces of this shell are resistant to liquids and chemicals, thus facilitating cleaning and decontamination of the area.

Laboratory Facility (Secondary Barriers)

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Biosafety Level 4

All penetrations in these structures and surfaces are sealed. Any drains in the floors contain traps filled with a chemical disinfectant of demonstrated efficacy against the target agent, and they are connected directly to the liquid waste decontamination system. A foot, elbow, or automatically operatedhand-washing sink is provided near the door of each laboratory room in the facility.If water fountains are provided, they are foot operated and are located in the facility corridors outside the laboratory.

Laboratory Facility (Secondary Barriers)

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Biosafety Level 4

Access doors to the laboratory are self-closing and lockable.Any windows are breakage resistant.A double-doored autoclave is provided for decontaminating materials passing out of the facility. The airflow in the supply and exhaust components is monitored and the components interlocked to assure inward airflow is maintained.A specially designed suit area may be provided in the facility to provide personnel protection equivalent to that provided by Class III cabinets.

Laboratory Facility (Secondary Barriers)

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Biosafety Level 4

Access to the facility is limited by means of secure, locked doors; accessibility is managed by the laboratory director, biohazards control officer, or other person responsible for the physical security of the facility. Before entering, persons are advised of the potential biohazards and instructed as to appropriate safeguards for insuring their safety. A logbook, signed by all personnel, indicates the date and time of each entry and exit. When infectious materials or infected animals are present in the laboratory or animal rooms, hazard warning signs, incorporating the universal biohazard symbol, are posted on all access doors.

Special Practices

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Biosafety Level 4

Personnel enter and leave the facility only through the clothing change and shower rooms, and shower each time they leave the facility. Personnel use the airlocks to enter or leave the laboratory only in an emergency.Supplies and materials needed in the facility are brought in by way of the double-doored autoclave, fumigation chamber, or airlock, which is appropriately decontaminated between each use. Materials (e.g., plants, animals, and clothing) not related to the experiment being conducted are not permitted in the facility.

Special Practices

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Relationships

Risk Group BSL Level Examples Practices Facilities,

Equipment

1 BasicBSL 1

Basic Teaching, Research

Good Microbiological Techniques (GMT)

None required; open benchwork, directional airflow

2 BasicBSL 2

Primary health services, diagnostic, teaching, public health

Level 1 plus protective clothing, biohazard signage

Open bench plus Biological Safety Cabinet (BSC) for aerosols

3 ContainmentBSL 3

Special diagnostic, research

Level 2 plus special clothing, controlled access

BSC and/or other primary containment devices for all activities

4Maximum

ContainmentBSL 3

Dangerous pathogen unit

Level 3 plus airlock entry, shower exit, special waste disposal

Class III BSC or positive pressure suits, double door autoclave, filtered air

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Some Available References for Risk Assessment and Lab Safety

Laboratory Biosafety Manual, 3rd edition

World Health OrganizatioGeneva 2004