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BIOSAFETY
REGULATIONS
BY: AYESHA
We are going to discuss:
 Biosafety regulation
 Agents and Risk
 Biosafety regulations in Transportation
of biological specimens
 Biosafety levels in a laboratory
 General disinfection principles
What is Biosafety
Regulation?
Principles and practices employed to
protect laboratory personnel and the
environment from exposure or infection
while working with living organisms,
biological materials, or agents.
Example:
Include any material that may be
potentially infectious
Why we need biosafety ????
Lab has hazards of processing infectious
agents
Accidental threat to workers and
environment
To have adherence with safety regulations
while dealing with highly infectious agents
Accidental exposure to pathogens while
their transportation
Biosafety principles:
To protect
 Our self
 the environment
 the community
Agents and Risk groups:
The “agent” is the what creates risk, it might
be a virus, Bacteria or any pathogen
Risks to the worker or environment are often
unknown
Risk Group 1 Agents
E.coli
Fungi
Mold
Yeast
Unlikely to cause animal or human
disease
Non pathogenic agent
Risk Group 2 Agents
Human or Primate Cells
Herpes Simplex Virus
Patient specimens
Pathogenic for humans
Unlikely a serious hazard
Treatment and preventive measures available
Limited risk of spread of infection
Risk Group 3 Agents
Human Immunodeficiency Virus
Mycobacterium tuberculosis
Pathogenic, cause serious disease
Effective treatment and preventive
measures usually available
Little person-to-person spread
Risk Group 4 Agents
Lassa Fever Virus
Ebola Hemmorrhagic Fever Virus
Marburg Virus
Herpes B Virus
Lethal, pathogenic agent
Readily transmittable
direct, indirect transfer
Effective treatment and preventive measures not
usually available
Biosafety levels in a laboratory
Level 1& 2: basic laboratories
Level 3: containment laboratories
Level 4 : high containment laboratories
Each level associated with appropriate
equipment, practices, work procedures
Level 1
 Well characterized, non-pathogenic organisms or
agents
 Open bench- no containment
 Use good laboratory practices, waste disposal, and
aseptic techniques
 Example: E. coli K-12 strains
Level 2
Agents of moderate hazard to personnel or
environment
Basic lab, but restricted access, containment
during certain processes (i.e. aerosols).
Autoclave and Biological Safety Cabinet are used
Use good laboratory practices, waste disposal,
and aseptic techniques
Example: most non-respiratory, non lethal,
agents
Level 3
• Agents of high hazard to personnel or environment
• Respiratory exotic or indigenous agents which are
easily transmissible causing serious or lethal
disease
• All work is done under, engineering controls and
controlled environments
• Example: Mycobacterium tuberculosis
Level 4
• Total containment, airtight labs,
“submarine” doors, air pumps, water
treatment, etc.
• Positive pressure “moonsuits”
• Hemorrhagic fever, deadly viruses, etc.
Biosafety regulations in
Transportation:
For the Transport of infectious substances or the specimen
under study or any virus or bacteria needs
 proper packaging materials
 proper use of packaging materials
 proper labelling, notification
Triple packaging
primary receptacle
secondary packaging
outer packaging
protects the environment, the carrier
protects the sample
arrival in good condition for analysis
primary receptacle
 Leak-proof specimen container
 Packaged with sufficient absorbent material to
absorb the entire content of the primary
receptacle in case of breakage
secondary packaging
Leak-proof secondary container
Encloses and protects the primary
receptacle(s)
several cushioned primary receptacles
may be placed in one secondary packaging
sufficient additional absorbent material to
absorb all fluid in case of breakage
Outer packaging
 Secondary packaging(s) are
placed in outer shipping packaging
with suitable cushioning material
 Outer packaging protects contents
from outside influences, physical
damage, while in transit
General disinfection
principles
 Disinfection requirements depend on the
experimental work and nature of the agents being
handled
 Contact time and concentration for disinfectants are
specific for each material and manufacturer
 Efficacy is a function of surface, contact time,
product, dilution
General disinfectants
10% bleach solution
 good for general disinfection
 High organics use 20%
 Needs to be made weekly
Ethanol
 Use 70% solution (most effective)
 Longer contact time

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BIOSAFETY REGULATIONS pptx

  • 2. We are going to discuss:  Biosafety regulation  Agents and Risk  Biosafety regulations in Transportation of biological specimens  Biosafety levels in a laboratory  General disinfection principles
  • 3. What is Biosafety Regulation? Principles and practices employed to protect laboratory personnel and the environment from exposure or infection while working with living organisms, biological materials, or agents. Example: Include any material that may be potentially infectious
  • 4. Why we need biosafety ???? Lab has hazards of processing infectious agents Accidental threat to workers and environment To have adherence with safety regulations while dealing with highly infectious agents Accidental exposure to pathogens while their transportation
  • 5. Biosafety principles: To protect  Our self  the environment  the community
  • 6. Agents and Risk groups: The “agent” is the what creates risk, it might be a virus, Bacteria or any pathogen Risks to the worker or environment are often unknown
  • 7. Risk Group 1 Agents E.coli Fungi Mold Yeast Unlikely to cause animal or human disease Non pathogenic agent
  • 8. Risk Group 2 Agents Human or Primate Cells Herpes Simplex Virus Patient specimens Pathogenic for humans Unlikely a serious hazard Treatment and preventive measures available Limited risk of spread of infection
  • 9. Risk Group 3 Agents Human Immunodeficiency Virus Mycobacterium tuberculosis Pathogenic, cause serious disease Effective treatment and preventive measures usually available Little person-to-person spread
  • 10. Risk Group 4 Agents Lassa Fever Virus Ebola Hemmorrhagic Fever Virus Marburg Virus Herpes B Virus Lethal, pathogenic agent Readily transmittable direct, indirect transfer Effective treatment and preventive measures not usually available
  • 11. Biosafety levels in a laboratory Level 1& 2: basic laboratories Level 3: containment laboratories Level 4 : high containment laboratories Each level associated with appropriate equipment, practices, work procedures
  • 12. Level 1  Well characterized, non-pathogenic organisms or agents  Open bench- no containment  Use good laboratory practices, waste disposal, and aseptic techniques  Example: E. coli K-12 strains
  • 13. Level 2 Agents of moderate hazard to personnel or environment Basic lab, but restricted access, containment during certain processes (i.e. aerosols). Autoclave and Biological Safety Cabinet are used Use good laboratory practices, waste disposal, and aseptic techniques Example: most non-respiratory, non lethal, agents
  • 14. Level 3 • Agents of high hazard to personnel or environment • Respiratory exotic or indigenous agents which are easily transmissible causing serious or lethal disease • All work is done under, engineering controls and controlled environments • Example: Mycobacterium tuberculosis
  • 15. Level 4 • Total containment, airtight labs, “submarine” doors, air pumps, water treatment, etc. • Positive pressure “moonsuits” • Hemorrhagic fever, deadly viruses, etc.
  • 16. Biosafety regulations in Transportation: For the Transport of infectious substances or the specimen under study or any virus or bacteria needs  proper packaging materials  proper use of packaging materials  proper labelling, notification
  • 17. Triple packaging primary receptacle secondary packaging outer packaging protects the environment, the carrier protects the sample arrival in good condition for analysis
  • 18. primary receptacle  Leak-proof specimen container  Packaged with sufficient absorbent material to absorb the entire content of the primary receptacle in case of breakage
  • 19. secondary packaging Leak-proof secondary container Encloses and protects the primary receptacle(s) several cushioned primary receptacles may be placed in one secondary packaging sufficient additional absorbent material to absorb all fluid in case of breakage
  • 20. Outer packaging  Secondary packaging(s) are placed in outer shipping packaging with suitable cushioning material  Outer packaging protects contents from outside influences, physical damage, while in transit
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  • 22. General disinfection principles  Disinfection requirements depend on the experimental work and nature of the agents being handled  Contact time and concentration for disinfectants are specific for each material and manufacturer  Efficacy is a function of surface, contact time, product, dilution
  • 23. General disinfectants 10% bleach solution  good for general disinfection  High organics use 20%  Needs to be made weekly Ethanol  Use 70% solution (most effective)  Longer contact time