3. svce.ac.in
An overview of Biosafety
¤ Biosafety (biosafety regulation) means the need to protect human and animal health and
environment from the possible adverse effects of the products of modern biotechnology.
¤ Biosafety defines the containment conditions under which infectious agents can be safely
manipulated.
¤ Biosafety is the prevention of large-scale loss of biological integrity, focusing both on
ecology and human health.
Dr NARESHMANICKAM
4. svce.ac.in
Need of biosafety
¤ In the past century, medical research has led to improved health and increased life
expectancy largely because of success in preventing and treating infectious diseases.
¤ This success has come about through the use of antibiotics and vaccines, improved
hygiene, and increased public awareness.
¤ New threats to health continually emerge naturally, however, as bacteria and viruses
evolve, are transported to new environments, or develop resistance to drugs and
vaccines
Dr NARESHMANICKAM
7. svce.ac.in Dr NARESHMANICKAM
Multi drug resistance!
• The rapid emergence of resistant bacteria is
occurring worldwide, endangering the efficacy of
antibiotics, which have transformed medicine and
saved millions of lives.
• Many decades after the first patients were
treated with antibiotics, bacterial infections have
again become a threat
9. svce.ac.in Dr NARESHMANICKAM
Biosafety guidelines aiming at….
• Regulating rDNA research with organisms that have least or no adverse effect.
• Minimizing the possibilities of occasional release of GEOs from the lab.
• Banning the release of GEOs if they are supposed to be causing potential risks in
the environment
10. svce.ac.in Dr NARESHMANICKAM
Biosafety guidelines aiming at….
• Regulating rDNA research with organisms that have least or no adverse effect.
• Minimizing the possibilities of occasional release of GEOs from the lab.
• Banning the release of GEOs if they are supposed to be causing potential risks in
the environment
11. svce.ac.in Dr NARESHMANICKAM
Biosafety Guidelines for Laboratories
• Food storage, eating, drinking and smoking are prohibited in lab.
• Mouth pipetting is prohibited
• Laboratory coats are obligatory and should be removed when exiting the lab.
• Working surfaces must be decontaminated using soap and alcohol after each working day.
• Waste products must be decontaminated by incineration or by autoclaving.
• Frequent hand wash is obligatory.
• Avoid contact with GMO's and other exotic biological agents, disposable gloves should be worn when handling such items.
• Laboratory door should be closed at all times.
• Working with fume-producing chemicals must be under the laboratory hood.
• Biohazard warning signs should be always posted in labs
12. svce.ac.in Dr NARESHMANICKAM
Bio-Safety Levels
Biosafety levels are defined in terms of using specific laboratory practices and techniques, safety equipment
and laboratory facilities required for different category of infectious agents based on their hazardous nature.
The guidelines for Microbiological and Biomedical Laboratories suggest four Biosafety levels in incremental
order depending on the nature of work.
The proposed safety levels for projects involving recombinant DNA techniques take into consideration the
source of the donor DNA and its disease-producing potential.
14. svce.ac.in Dr NARESHMANICKAM
Biosafety level-1
BSL-1 level is suitable for working with well characterized agents which are not known to cause any disease in
healthy human beings and are of minimal hazard to workers in the laboratory as well as to the environment
e.g. non-pathogenic E. coli. No special equipment is required.
The safety precautions and requirement of BSL-1
Features:
1. Following of good microbiological practices i.e using laminar flows, washing hands with anti-bacterial soap, cleaning
working benches of the lab with disinfectants,
2. Decontamination of bacterial cultures by autoclaving etc.
3. The laboratory personnel should be imparted specific training and also be supervised by a scientist with general
training in microbiology.
16. svce.ac.in Dr NARESHMANICKAM
Biosafety level-2
BSL-2 level is suitable for working with agents of moderate potential hazard to laboratory personnel and the environment e.g.
Salmonella spp., E. coli 0157:H7, Listeria monocytogenes, mumps, measles, influenza etc. including genetically modified organisms.
Features of BSL-2
1. BSL-2 facility limits the release of modified organisms in the environment.
2. Class II safety cabinets are required to be used in handling the high risk organisms under this category. Thus, the Class II biosafety
cabinet provides personnel, environment and product protection.
3. Laboratory personnel are to be provided with specific training in handling pathogenic agents and to be supervised by competent
scientists.
4. The access to the laboratory is limited where work is being conducted.
5. Each and everything used should be decontaminated either by autoclaving or putting them in disinfectants.
18. svce.ac.in Dr NARESHMANICKAM
Biosafety level-3
BSL-3 level facility is required for working with agents such as bacteria and viruses which can cause severe to fatal disease in
humans on inhalation e.g. Mycobacterium tuberculosis, Bacillus anthracis, Q fever, and SARS coronavirus. However, such diseases
can be treated with vaccines or other treatments.
Important feature of BSL-3
1. BSL-3 laboratory has special engineering and design features e.g. double door access zone and sealed penetration.
2. Laboratory personnel need to be specifically trained in handling pathogenic and potentially lethal agents and should be supervised by
competent scientists having adequate expertise in working with these agents.
3. It is mandatory to conduct all procedures involving the manipulation of infectious materials within biological safety cabinets or other
physical containment facilities or by personnel wearing appropriate personal protective clothing and equipment.
19. svce.ac.in Dr NARESHMANICKAM
Biosafety level-3
4. Specially designed laboratories (BSL-3 laboratory with double door access zone and sealed penetration) and precautions
including the use of safety cabinets are prescribed and the access is strictly controlled.
5. Class III cabinets are generally used for working with the pathogens falling in this category. It is a totally enclosed ventilated
cabinet of gas-tight construction. The work within this cabinet is conducted through attached rubber gloves.
6. When in use, the Class III cabinet is maintained through negative air pressure of at least 0.5 inches water gauge. The supply air
is drawn into the cabinet through HEPA filters. The cabinet exhaust air is filtered by two HEPA filters, installed in series, before its
discharge outside the facility.
7. The exhaust fan for the Class III cabinet is generally separate from the exhaust fans of the facility's ventilation system.
21. svce.ac.in Dr NARESHMANICKAM
Biosafety level-4
BSL-4 level is required for working with highly dangerous agents that pose a high risk to the workers through
transmission by aerosols and lead to fatal diseases for which no treatment or vaccines are available e.g. Bird
flu, swine flu, hemorrhagic fever, Ebola virus, Foot and Mouth Disease virus etc.
1. It requires the use of ‘Hazmat suit’ and a self-contained oxygen supply.
2. The entrance and exit contain multiple showers, a vacuum room, ultraviolet room as well as all the precautions designed to
destroy the biohazardous waste. Multiple locks are employed which are electronically secured to prevent both doors opening at the
same time. The air and water services to BSL-4 has to undergo decontamination procedures to eliminate the possibility of an
accidental release.
3. BSL-4 facility has to be created in a controlled area within the premises of the institute / industry or as a separate facility
outside the building which is located away the other areas.
22. svce.ac.in Dr NARESHMANICKAM
Biosafety level-4
4. The building protocols should use negative pressurized facilities. Airlocks should be provided during entry and
exit of the personnel working in lab.
5. Specific facility operation manual has to be prepared.
6. The researchers / workers / personnel working in the BSL-4 facility should be given specialized training in
handling hazardous infectious agents and should be well versant with the containment equipment and laboratory
7. Design so that they follow all practices religiously.
24. svce.ac.in Dr NARESHMANICKAM
Biosafety level-4
4. The building protocols should use negative pressurized facilities. Airlocks should be provided during entry and
exit of the personnel working in lab.
5. Specific facility operation manual has to be prepared.
6. The researchers / workers / personnel working in the BSL-4 facility should be given specialized training in
handling hazardous infectious agents and should be well versant with the containment equipment and laboratory
7. Design so that they follow all practices religiously.
