Prof dr badr elsabah biosafety in biotech

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

When Biotechnology
begin?

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.

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

Biotechnology
Used to make products
more useful or desirable
Ex: conversion of milk into
cheese or yogurt

Biotechnology
• Improvements by using
science
• Science helps in production
plants, animals and other
organisms

Biotechnology
• Also used in maintaining
a good environment that
promotes our well being

Biotechnology
• Using scientific processes to
get new organisms or new
products from organisms.

Biotechnology
• Large area
• Includes many approaches
and methods in science and
technology

Application of Biotechnology :

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/

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.

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.

What is Safety?
Safety from exposure to Infectious
Agents and dangerous conditions

Biosafety in Various Disciplines
Biosafety is related to several
fields……..
•ECOLOGY: referring to imported
life forms not indigenous to the
region (Reggie the alligator).
•AGRICULTURE: reducing the
risk of alien viral or transgenic
genes, or prions such as
BSE/"MadCow―; reducing the risk
of food bacterial contamination.
•MEDICINE: referring to organs or
tissues from biological origin, or
genetic therapy products, virus;
levels of lab containment protocols
BSL-1, 2, 3, 4 in rising order of
danger.
•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―.

Biosafety in Academic Research
Research Universities:
Promoting safe laboratory
practices, and procedures;
proper use of containment
equipment and facilities;
provides advice on
laboratory design and risk
assessment of experiments
involving infectious agents,
rDNA in-vitro and in-vivo.

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

Biosafety Issues
• Laboratory Safety
• Bloodborne pathogens (BBP).
• Recombinant DNA (rDNA).
• Biological waste disposal.
• Infectious substance and
diagnostic specimen shipping.
• Genetically Modified Organisms (GMO).

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
models

Biohazardous Materials
• Viruses
• Bacteria
• Fungi
• Chlamydiae/Rickettsiae
• Prions
• Recombinant DNA

Biohazardous materials
• Transgenic Plants, Animals and Insects

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

Biosafety Concepts for Biotech.
• Practice and Procedures
– Standard Practices
– Special Practices & Considerations
• Safety Equipments
• Facility Design and Construction
• Increasing levels of protection

Principles of Biosafety
Biosafety 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

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

(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

(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.

Laboratory Design

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

Risk Group 1 Agents
• E.coli K-12
• Transgenic Plants
• Plasmids
• Fungi
• Mold
• Yeast

BSL-1 Practices
• Bench-top work allowed
• Daily Decontamination
• Manual pipetting
• Required Handwashing
• Red bag waste
• Bio cabinet not required (unless
creating aerosols)
• 2˚ containment

Risk Group 2 Agents
• Human or Primate Cells
• Herpes Simplex Virus
• Replication Incompetent
Attenuated Human
Immunodeficiency Virus
• Patient specimens

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

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

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

Risk Group 3 Agents
• Human
Immunodeficiency
Virus
• Mycobacterium
tuberculosis
• Coxiella burnetii

Biosafety Level 3
Working in High
Containment
Biosafety Level-3 (BSL-3)
• Indigenous or exotic agents
• Aerosol transmission
• Serious health effects
• Treatment may or may not exist

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
necessary

• 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‖

• 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

Biosafety Level-4
Working 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

Biosafety Level 4
• Lassa Fever Virus
• Ebola
Hemmorrhagic
Fever Virus
• Marburg Virus
• Herpes B Virus

Biosafety Concepts
Working 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

Animal Biosafety Level-4
Working in High Containment

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

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

Risk Assessment
In-Vitro In-Vivo
Human Clinical
Trial

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?

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

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?

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?

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?

First Aid Measures
• Splash to Eye or Needlestick Injury
– Rinse thoroughly for 15 minutes at the eyewash or
sink

What Helps?

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.

Thank you for your attention !
drabadrelsabah@hotmail.com

Prof dr badr elsabah biosafety in biotech

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