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Safety Aspects in Biotechnology:
Classifications, Safety Measurements
and Precautions for Biological Workers
By
Badr El-Sa...
About Speaker:
Professor and Head Research in Plant
Protection Research Institute, ARC, Egypt
Editor in Chief in Biochemis...
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: mai...
Biotechnology
• Biotechnology helps to meet
our basic needs.
• Food, clothing, shelter, health
and safety
 Plants and ani...
Biotechnology
Used to make products
more useful or desirable
Ex: conversion of milk into
cheese or yogurt
Prof. Badr El-...
Biotechnology
• Improvements by using
science
• Science helps in production
plants, animals and other
organisms
Prof. Badr...
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. Fet...
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 Biote...
Sunday, Sep. 20, 2009
Did the Plague Kill Illinois Scientist?
By AP
(AP / CHICAGO) — The University of Chicago Medical Cen...
In June 2014 about 75 American researchers faced to
anthrax.
After just one month, and during the cleaning routine
laborat...
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 several
fields……..
•ECOLOGY: referring to imported
life forms not...
Biosafety in Academic Research
Research Universities:
Promoting safe laboratory
practices, and procedures;
proper use of c...
Prof. Badr El-Sabah A. Fetoh
Biohazard Symbol
• In 1991Charles Baldwin
at National Cancer
Institute at NIH, USA.
• Symbol to be
―memorable but
meaningl...
Biosafety Issues
• Laboratory Safety
• Bloodborne pathogens (BBP).
• Recombinant DNA (rDNA).
• Biological waste disposal.
...
Biosafety Issues (con’t.)
• Respiratory Protection
• Bioterrorism and Select
agents
• Mold and indoor air quality
• Occupa...
Biohazardous Materials
• Viruses
• Bacteria
• Fungi
• Chlamydiae/Rickettsiae
• Prions
• Recombinant DNA
Prof. Badr El-Saba...
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, b...
Biohazardous Materials
• Human and Primate Cells, Tissues, and
Body Fluids
• Brain Tissue from Demented Patients
• Viral V...
Biosafety Concepts for Biotech.
• Practice and Procedures
– Standard Practices
– Special Practices & Considerations
• Safe...
Principles of Biosafety
Biosafety Levels 1-4 (BSL)
• Increasing levels of employee and
environmental protection
• Guidelin...
Biosafety Concepts
(1) Standard Microbiological
Practices
• Most important concept / Strict adherence
• Aware of potential...
Prof. Badr El-Sabah A. Fetoh
(2) Safety Equipments
• Primary Containment Barrier
• Minimize exposure to hazard
– Prevent contact / Contain aerosols
• E...
Prof. Badr El-Sabah A. Fetoh
(3) Facility Design and Construction
• Secondary Barrier/ Engineering controls
• Contributes to worker protection
• Protec...
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
he...
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...
Risk Group 2 Agents
• Human or Primate Cells
• Herpes Simplex Virus
• Replication Incompetent
Attenuated Human
Immunodefic...
BSL-2 Practices
Practices & Procedures
• Agents associated w/ human disease
• Treatment for disease available
• Agent pose...
BSL-2 Practices
• Limited access to lab when work
in progress
• Daily decontamination
• Mechanical pipetting
• Labcoat, sa...
BSL-2 Practices (con’t)
• Biohaz. Sign posted at
entrance to lab
• Label all equipment
(incubators, freezers, etc.)
• TC r...
Risk Group 3 Agents
• Human
Immunodeficiency
Virus
• Mycobacterium
tuberculosis
• Coxiella burnetii
Prof. Badr El-Sabah A....
Biosafety Level 3
Working in High
Containment
Biosafety Level-3 (BSL-3)
• Indigenous or exotic agents
• Aerosol transmissi...
BSL-3 Practices
• Public access NOT permitted
• Daily decontamination after spill and
upon completion of experiment
• Auto...
BSL-3 Practices (con’t)
• Aerosol minimization procedures required
• Wrap around disposable clothing is
required. Speciali...
BSL-3 Practices (con’t)
• Bench top work not permitted
• Documented training and personnel competency
certification (for B...
Biosafety Level-4
Working in High Containment
Biosafety Level-4
• Builds on BSL-3 practices
• Maximum containment faciliti...
Biosafety Level 4
• Lassa Fever Virus
• Ebola
Hemmorrhagic
Fever Virus
• Marburg Virus
• Herpes B Virus
Prof. Badr El-Saba...
Biosafety Concepts
Working in High
Containment
Biosafety Level-4 (BSL-4 )
• Dangerous/exotic agents
• Life threatening dis...
Animal Biosafety Level-4
Working 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 ...
General Operational Practices
• Proper attire
– Minimum – lab coat, safety glasses, gloves
• Plan your work
– Know in adva...
Animal Containment Points
1957 2005
Prof. Badr El-Sabah A. Fetoh
Risk Assessment
In-Vitro In-Vivo
Human 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...
Risk Assessment, con’t
• Are personnel trained? Do
personnel understand the
organism, infectious dose and
symptoms?
• What...
Risk Assessment, Con’t
• Are they doing this
work in-vivo? Have
you consulted and
discussed this with
the Vets and IACUC
t...
Risk Assessment, con’t
• Do they share their
Tissue Culture room?
• Do they have more
than 1 Biosafety
Cabinet?
• Occupati...
Accidental Spills
 Evacuate area, alert personnel and
cordon off so that aerosols may settle
 Don PPE; Cover with paper ...
First Aid Measures
• Splash to Eye or Needlestick Injury
– Rinse thoroughly for 15 minutes at the eyewash or
sink
Prof. Ba...
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
Bio...
Thank you for your attention !
drabadrelsabah@hotmail.com
Prof. Badr El-Sabah A. Fetoh
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Prof dr badr elsabah biosafety in biotech

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Biosafety in Biotechnology for Biological Workers

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Prof dr badr elsabah biosafety in biotech

  1. 1. Safety Aspects in Biotechnology: Classifications, Safety Measurements and Precautions for Biological Workers By Badr El-Sabah A. Fetoh
  2. 2. 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
  3. 3. Prof. Badr El-Sabah A. Fetoh
  4. 4. When Biotechnology begin? Prof. Badr El-Sabah A. Fetoh
  5. 5. Prof. Badr El-Sabah A. Fetoh
  6. 6. Prof. Badr El-Sabah A. Fetoh
  7. 7. 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
  8. 8. 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
  9. 9. Biotechnology Used to make products more useful or desirable Ex: conversion of milk into cheese or yogurt Prof. Badr El-Sabah A. Fetoh
  10. 10. Biotechnology • Improvements by using science • Science helps in production plants, animals and other organisms Prof. Badr El-Sabah A. Fetoh
  11. 11. Biotechnology • Also used in maintaining a good environment that promotes our well being Prof. Badr El-Sabah A. Fetoh
  12. 12. Biotechnology • Using scientific processes to get new organisms or new products from organisms. Prof. Badr El-Sabah A. Fetoh
  13. 13. Biotechnology • Large area • Includes many approaches and methods in science and technology Prof. Badr El-Sabah A. Fetoh
  14. 14. Prof. Badr El-Sabah A. Fetoh
  15. 15. Application of Biotechnology : Prof. Badr El-Sabah A. Fetoh
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. What is Safety? Safety from exposure to Infectious Agents and dangerous conditions Prof. Badr El-Sabah A. Fetoh
  20. 20. 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―. Prof. Badr El-Sabah A. Fetoh
  21. 21. 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. Prof. Badr El-Sabah A. Fetoh
  22. 22. Prof. Badr El-Sabah A. Fetoh
  23. 23. 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
  24. 24. 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
  25. 25. 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 Prof. Badr El-Sabah A. Fetoh
  26. 26. Biohazardous Materials • Viruses • Bacteria • Fungi • Chlamydiae/Rickettsiae • Prions • Recombinant DNA Prof. Badr El-Sabah A. Fetoh
  27. 27. Biohazardous materials • Transgenic Plants, Animals and Insects Prof. Badr El-Sabah A. Fetoh
  28. 28. Prof. Badr El-Sabah A. Fetoh
  29. 29. 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.
  30. 30. 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
  31. 31. 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
  32. 32. 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 Prof. Badr El-Sabah A. Fetoh
  33. 33. 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
  34. 34. Prof. Badr El-Sabah A. Fetoh
  35. 35. (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
  36. 36. Prof. Badr El-Sabah A. Fetoh
  37. 37. (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
  38. 38. Laboratory Design Prof. Badr El-Sabah A. Fetoh
  39. 39. 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
  40. 40. Risk Group 1 Agents • E.coli K-12 • Transgenic Plants • Plasmids • Fungi • Mold • Yeast Prof. Badr El-Sabah A. Fetoh
  41. 41. 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 Prof. Badr El-Sabah A. Fetoh
  42. 42. 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
  43. 43. 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
  44. 44. 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
  45. 45. 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
  46. 46. Risk Group 3 Agents • Human Immunodeficiency Virus • Mycobacterium tuberculosis • Coxiella burnetii Prof. Badr El-Sabah A. Fetoh
  47. 47. 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 Prof. Badr El-Sabah A. Fetoh
  48. 48. 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 Prof. Badr El-Sabah A. Fetoh
  49. 49. 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
  50. 50. 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
  51. 51. 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 Prof. Badr El-Sabah A. Fetoh
  52. 52. Biosafety Level 4 • Lassa Fever Virus • Ebola Hemmorrhagic Fever Virus • Marburg Virus • Herpes B Virus Prof. Badr El-Sabah A. Fetoh
  53. 53. 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 Prof. Badr El-Sabah A. Fetoh
  54. 54. Animal Biosafety Level-4 Working in High Containment Prof. Badr El-Sabah A. Fetoh
  55. 55. 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
  56. 56. 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
  57. 57. Animal Containment Points 1957 2005 Prof. Badr El-Sabah A. Fetoh
  58. 58. Risk Assessment In-Vitro In-Vivo Human Clinical Trial Prof. Badr El-Sabah A. Fetoh
  59. 59. 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
  60. 60. 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
  61. 61. 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
  62. 62. 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
  63. 63. 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
  64. 64. 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
  65. 65. What Helps? Prof. Badr El-Sabah A. Fetoh
  66. 66. 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
  67. 67. Thank you for your attention ! drabadrelsabah@hotmail.com Prof. Badr El-Sabah A. Fetoh

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