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Safety Aspects in Biotechnology:
Classifications, Safety Measurements
and Precautions for Biological Workers
By
Badr El-Sabah A. Fetoh
About Speaker:Professor and Head Research in Plant
Protection Research Institute, ARC, Egypt
Editor in Chief in Biochemistry and
Biotechnology Research Journal, UK.
Email: drabadrelsabah@hotmail.com
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
When Biotechnology
begin?
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
What is Biotechnology?Processing of substances by biological agents to
produce goods and services.
Biological agents: mainly microbes, animal and
plant cells and enzymes.
Substances: renewable materials as well as those
produced by microbes.
Goods and services: food,, pharmaceuticals, etc.
Prof. Badr El-Sabah A. Fetoh
Biotechnology• Biotechnology helps to meet
our basic needs.
• Food, clothing, shelter, health
and safety
Plants and animals are used in manufacturing food, clothing and materials for shelter
Prof. Badr El-Sabah A. Fetoh
Biotechnology
Used to make products
more useful or desirable
Ex: conversion of milk into
cheese or yogurt
Prof. Badr El-Sabah A. Fetoh
Biotechnology
• Improvements by using
science
• Science helps in production
plants, animals and other
organisms
Prof. Badr El-Sabah A. Fetoh
Biotechnology
• Also used in maintaining a good environment that promotes our well being
Prof. Badr El-Sabah A. Fetoh
Biotechnology
• Using scientific processes to
get new organisms or new
products from organisms.
Prof. Badr El-Sabah A. Fetoh
Biotechnology
• Large area
• Includes many approaches
and methods in science and
technology
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
Application of Biotechnology :
Prof. Badr El-Sabah A. Fetoh
No matter your research, likely to
encounter biotechnology……….
Green Agriculture/Envirnoment
Red Medical
Yellow Food Biotechnology
Blue Aquatic
White Gene-Based Industry
Grey Fermentation
Brown Arid
Gold Nanotechnology/Bioinformatics
Purple Intellectual
Dark Warfare/Bioterrorism/
Prof. Badr El-Sabah A. Fetoh
Sunday, Sep. 20, 2009
Did the Plague Kill Illinois Scientist?
By AP
(AP / CHICAGO) — The University of Chicago Medical Center says the
infection that killed a scientist may be connected to bacteria he
researched that causes the plague.
The university said Saturday that its researcher studied the genetics of
harmful bacteria including Yersinia pestis, which causes the illness.
He died Sept. 13. His name and age haven't been released
The medical center says the bacteria he worked with was a weakened
strain that isn't known to cause illness in healthy adults. The strain
was approved by the Centers for Disease Control and Prevention for
laboratory studies.
An autopsy found no obvious cause of death but did find the presence
of the bacteria. More tests are planned. No other illnesses have
been reported.
Prof. Badr El-Sabah A. Fetoh
In June 2014 about 75 American researchers faced to
anthrax.
After just one month, and during the cleaning routine
laboratory at the National Institute of Health in the United
States, appeared 16 vials containing the smallpox virus,
found in misplaced storage repositories.
Fortunately, no one gets sick, but the uproar caused by
this issue prompted the Obama administration to stop
funding the controversial research, which deliberately
make diseases such as bird flu and SARS more virulent.
Prof. Badr El-Sabah A. Fetoh
What is Safety?
Safety from exposure to Infectious
Agents and dangerous conditions
Prof. Badr El-Sabah A. Fetoh
Biosafety in Various Disciplines
Biosafety is related to severalfields……..
•ECOLOGY: referring to importedlife forms not indigenous to theregion (Reggie the alligator).
•AGRICULTURE: reducing therisk of alien viral or transgenicgenes, or prions such asBSE/"MadCow―; reducing the riskof food bacterial contamination.
•MEDICINE: referring to organs ortissues from biological origin, orgenetic therapy products, virus;levels of lab containment protocolsBSL-1, 2, 3, 4 in rising order ofdanger.
•CHEMISTRY: i.e., nitrates in water, PCB levels affecting fertility.
•EXOBIOLOGY: i.e., NASA's policy for containing alien microbes that may exist on space samples - sometimes called "biosafety level 5―.
Prof. Badr El-Sabah A. Fetoh
Biosafety in Academic Research
Research Universities:
Promoting safe laboratorypractices, and procedures;proper use of containmentequipment and facilities;provides advice onlaboratory design and riskassessment of experimentsinvolving infectious agents,rDNA in-vitro and in-vivo.
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
Biohazard Symbol
• In 1991Charles Baldwin at National Cancer Institute at NIH, USA.
• Symbol to be ―memorable but meaningless‖ so it could be learned.
• Blaze orange – most visible under harsh conditions
Prof. Badr El-Sabah A. Fetoh
Biosafety Issues
• Laboratory Safety
• Bloodborne pathogens (BBP).
• Recombinant DNA (rDNA).
• Biological waste disposal.
• Infectious substance and
diagnostic specimen shipping.
• Genetically Modified Organisms (GMO).
Prof. Badr El-Sabah A. Fetoh
Biosafety Issues (con’t.)
• Respiratory Protection
• Bioterrorism and Select
agents
• Mold and indoor air quality
• Occupational safety and
health in the use of
research animals
• Biohazards used in animal
modelsProf. Badr El-Sabah A. Fetoh
Biohazardous Materials
• Viruses
• Bacteria
• Fungi
• Chlamydiae/Rickettsiae
• Prions
• Recombinant DNA
Prof. Badr El-Sabah A. Fetoh
Biohazardous materials• Transgenic Plants, Animals and Insects
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
In 2014 Chinese team researchers announced the first birth of
monkeys genetically modified, by modifying the new Jenny called
"CRISPR / Cas9" system, and the promise of this technology with a
new generation of monkeys specially designed for research, for the
best ways to discover for the treatment of human disease.
This discovery raises many ethical questions about how we deal with
this emotional and intelligent creatures.
Biohazardous Materials
• Human and Primate Cells, Tissues, and
Body Fluids
• Brain Tissue from Demented Patients
• Viral Vectors
– Replication deficient viruses
Prof. Badr El-Sabah A. Fetoh
Biosafety Concepts for Biotech.
• Practice and Procedures
– Standard Practices
– Special Practices & Considerations
• Safety Equipments
• Facility Design and Construction
• Increasing levels of protection
Prof. Badr El-Sabah A. Fetoh
Principles of BiosafetyBiosafety Levels 1-4 (BSL)
• Increasing levels of employee and environmental protection
• Guidelines for working safely in research & laboratory facilities
Animal Biosafety Levels 1- 4 (ABSL)
• Laboratory animal facilities
• Animal models that support research
• Guidelines for working safely in animal research facilities
Prof. Badr El-Sabah A. Fetoh
Biosafety Concepts
(1) Standard Microbiological Practices
• Most important concept / Strict adherence
• Aware of potential hazard
• Trained & proficient in techniques
• Supervisors responsible for: – Appropriate Laboratory facilities
– Personnel & Training
• Special practices & precautions– Occupational Health Programs
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
(2) Safety Equipments• Primary Containment Barrier
• Minimize exposure to hazard– Prevent contact / Contain aerosols
• Engineering controls/ equipment
• Personal Protective Equipment (PPE)– Gloves, gowns, Respirator, Face shield, Booties
• Biological Safety Cabinets
• Covered or ventilated animal cage systems
Prof. Badr El-Sabah A. Fetoh
Prof. Badr El-Sabah A. Fetoh
(3) Facility Design and Construction
• Secondary Barrier/ Engineering controls
• Contributes to worker protection
• Protects outside the laboratory
– Environment & Neighborhood
• Ex. Building & Lab design, Ventilation, Autoclaves, Cage wash facilities, etc.
Prof. Badr El-Sabah A. Fetoh
Laboratory Design
Prof. Badr El-Sabah A. Fetoh
Biosafety Level-1 (BSL-1)• Well characterized agents
• Agents not known to cause disease (in healthy human adults; now healthy immunocompetent adults)
• Prophylactic treatment available
• Open bench procedures
• Animals in open cage system or open environment (outdoors)
• Good laboratory practices
Prof. Badr El-Sabah A. Fetoh
Risk Group 1 Agents
• E.coli K-12
• Transgenic Plants
• Plasmids
• Fungi
• Mold
• Yeast
Prof. Badr El-Sabah A. Fetoh
BSL-1 Practices
• Bench-top work allowed
• Daily Decontamination
• Manual pipetting
• Required Handwashing
• Red bag waste
• Bio cabinet not required (unless
creating aerosols)
• 2˚ containmentProf. Badr El-Sabah A. Fetoh
Risk Group 2 Agents
• Human or Primate Cells
• Herpes Simplex Virus
• Replication Incompetent Attenuated Human Immunodeficiency Virus
• Patient specimens
Prof. Badr El-Sabah A. Fetoh
BSL-2 Practices
Practices & Procedures• Agents associated w/ human disease
• Treatment for disease available
• Agent poses moderate hazard to
personnel and environment
• Direct contact or exposure
• Percutaneous exposure
– Scratch, Puncture, Needle stick
• Mucus membrane exposure
– Eyes, Mouth, open cut
Prof. Badr El-Sabah A. Fetoh
BSL-2 Practices
• Limited access to lab when work
in progress
• Daily decontamination
• Mechanical pipetting
• Labcoat, safety glasses and
gloves required
• Red bag & sharps containers
required
Prof. Badr El-Sabah A. Fetoh
BSL-2 Practices (con’t)• Biohaz. Sign posted at
entrance to lab
• Label all equipment
(incubators, freezers, etc.)
• TC room – negative air flow
• Documented training
• Baseline serology or pre-
vaccination may be
required
Prof. Badr El-Sabah A. Fetoh
Risk Group 3 Agents
• Human
Immunodeficiency
Virus
• Mycobacterium
tuberculosis
• Coxiella burnetii
Prof. Badr El-Sabah A. Fetoh
Biosafety Level 3Working in High
Containment
Biosafety Level-3 (BSL-3)
• Indigenous or exotic agents
• Aerosol transmission
• Serious health effects
• Treatment may or may not exist
Prof. Badr El-Sabah A. Fetoh
BSL-3 Practices
• Public access NOT permitted
• Daily decontamination after spill and
upon completion of experiment
• Autoclave required and waste is
disposed at the end of day
• Required foot activated
handwashing sink and controls
• No sharps unless absolutely
necessaryProf. Badr El-Sabah A. Fetoh
BSL-3 Practices (con’t)• Aerosol minimization procedures required
• Wrap around disposable clothing is
required. Specialized equipment may be
required depending upon procedures
• Biohaz. Signs and labels posted
• Air flow from low hazard to high hazard
―Pressure Mapping‖
Prof. Badr El-Sabah A. Fetoh
BSL-3 Practices (con’t)• Bench top work not permitted
• Documented training and personnel competency
certification (for BSL-3 procedures)
• Baseline serology
• Spills – report immediately and treat accordingly
• Vaccinations/post exposure protocols and
SOP’s, Biosafety Manual, Biosafety Officer
Prof. Badr El-Sabah A. Fetoh
Biosafety Level-4Working in High Containment
Biosafety Level-4• Builds on BSL-3 practices
• Maximum containment facilities
• Pressurized Containment Suite– BSL-3 + Class III Biosafety Cabinet
• Chemical decontamination showers
• Liquid effluent collection / decontamination
Prof. Badr El-Sabah A. Fetoh
Biosafety Level 4
• Lassa Fever Virus
• Ebola
Hemmorrhagic
Fever Virus
• Marburg Virus
• Herpes B Virus
Prof. Badr El-Sabah A. Fetoh
Biosafety ConceptsWorking in High
Containment
Biosafety Level-4 (BSL-4 )
• Dangerous/exotic agents
• Life threatening disease
• Aerosol transmission
• Agents of unknown risk
of transmission or health affects
• No known treatment
Prof. Badr El-Sabah A. Fetoh
Animal Biosafety Level-4Working in High Containment
Prof. Badr El-Sabah A. Fetoh
General Good Lab Technique• Hygienic Practices
– No Smoking, Eating, Applying cosmetics, lip
balm, contacts
– Wash hands after procedures
– Decontaminate lab bench before and after
work
Prof. Badr El-Sabah A. Fetoh
General Operational Practices
• Proper attire
– Minimum – lab coat, safety glasses, gloves
• Plan your work
– Know in advance what you are working
with
– Read available resources like:
Blue Book:
http://www.oecd.org/dataoecd/45/54/194
3773.pdf
http://www.hc-sc.gc.ca/pphb-dgspsp/msds-
ftss/index.html Prof. Badr El-Sabah A. Fetoh
Animal Containment Points
1957 2005
Prof. Badr El-Sabah A. Fetoh
Risk Assessment
In-Vitro In-VivoHuman Clinical
Trial
Prof. Badr El-Sabah A. Fetoh
Addressing Risk Assessments
• What is the organism?
• Is it Wild-type, attenuated, irradiated, or chemically treated? Look at kill data or kill curves.
• What is the max. concentration, volume, infectious dose?
• What is the work space like?
• Aerosolizing procedures? How do they contain their aerosols?
Prof. Badr El-Sabah A. Fetoh
Risk Assessment, con’t• Are personnel trained? Do
personnel understand the organism, infectious dose and symptoms?
• What are their experimental procedures?
• Will they be transporting the material? Shipping intra, inter-state or international?
• Are they doing tissue culture?
• Do they have adequate containment equipment?
Tom
Pugh
Prof. Badr El-Sabah A. Fetoh
Risk Assessment, Con’t• Are they doing this
work in-vivo? Have you consulted and discussed this with the Vets and IACUC to determine special needs and housing?
• Waste issues addressed?
• Pregnancy issues with the organisms?
Prof. Badr El-Sabah A. Fetoh
Risk Assessment, con’t
• Do they share their
Tissue Culture room?
• Do they have more
than 1 Biosafety
Cabinet?
• Occupational Health
informed and set up to
receive patient or offer
counseling?Prof. Badr El-Sabah A. Fetoh
Accidental Spills
Evacuate area, alert personnel and
cordon off so that aerosols may settle
Don PPE; Cover with paper towels and
apply bleach (1 part bleach : 9 parts water
Allow 15 – 20 min contact time
Wipe up working towards center
Use tongs if broken glass is involved
Is Recombinant DNA involved?
Prof. Badr El-Sabah A. Fetoh
First Aid Measures
• Splash to Eye or Needlestick Injury
– Rinse thoroughly for 15 minutes at the eyewash or
sink
Prof. Badr El-Sabah A. Fetoh
What Helps?
Prof. Badr El-Sabah A. Fetoh
To be safe in biotech lab you must
focus on the following items:
• Risks versus Benefits
• Hazardous Materials Used in
Biotechnology—Handling and
Disposal
• Good Manufacturing Practices
• Good Laboratory Practices
• Good Laboratory Practice Principles.
Prof. Badr El-Sabah A. Fetoh
Thank you for your attention !
drabadrelsabah@hotmail.com
Prof. Badr El-Sabah A. Fetoh
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