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Basic Principles of Biosafety

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Basic Principles of Biosafety

  1. 1. Basic Principles of BiosafetyBasic Principles of BiosafetyMiguel Martin N. Moreno II, MDMiguel Martin N. Moreno II, MDScientist, SLMC, QC - RBDScientist, SLMC, QC - RBDFounding Secretary, PhBBA NationalFounding Secretary, PhBBA National
  2. 2. What is Biosafety? Safety from exposure toInfectious AgentsSmallpox
  3. 3. What is Biosafety?Sunday, Sep. 20, 2009Did the Plague Kill Illinois Scientist?By AP(AP / CHICAGO) — The University of Chicago Medical Center says the infection that killed ascientist may be connected to bacteria he researched that causes the plague.The university said Saturday that its researcher studied the genetics of harmful bacteria includingYersinia pestis, which causes the illness. He died Sept. 13. His name and age havent beenreleasedThe medical center says the bacteria he worked with was a weakened strain that isnt known to causeillness in healthy adults. The strain was approved by the Centers for Disease Control andPrevention for laboratory studies.An autopsy found no obvious cause of death but did find the presence of the bacteria. More tests areplanned. No other illnesses have been reported.
  4. 4. Biosafety in Various DisciplinesBiosafety is related to several fields 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 toorgans or tissues from biologicalorigin, or genetic therapyproducts, virus; levels of labcontainment protocols BSL-1, 2,3, 4 in rising order of danger CHEMISTRY: i.e., nitrates inwater, PCB levels affectingfertility EXOBIOLOGY: i.e., NASAspolicy for containing alienmicrobes that may exist on spacesamples. (Classified info.)
  5. 5. Biosafety in Academic Research Research Universities:Promoting safe laboratorypractices, and procedures;proper use of containmentequipment and facilities;provides advice onlaboratory design and riskassesment of experimentsinvolving infectious agents,rDNA in-vitro and in-vivo.Bottom Line: Risk & Containment
  6. 6. Biohazard Symbol Charles Baldwin atNational CancerInstitute at NIH. Symbol to be“memorable butmeaningless” so it couldbe learned. Blaze orange – mostvisible under harshconditions
  7. 7. Biosafety Issues Laboratory Safety Bloodborne pathogens (BBP) Recombinant DNA (rDNA) Biological waste disposal Infectious substance anddiagnostic specimen shipping
  8. 8. Biosafety Issues (con’t.) Respiratory Protection Bioterrorism and Select agents Mold and indoor air quality Occupational safety and health in the useof research animals Biohazards used in animal models
  9. 9. Biohazardous Materials Viruses Bacteria Fungi Chlamydiae/Rickettsiae Prions Recombinant DNA
  10. 10. Biohazardous materials Transgenic Plants, Animals and Insects
  11. 11. Biohazardous Materials Human and Primate Cells, Tissues, andBody Fluids Brain Tissue from Demented Patients Viral Vectors Replication deficient viruses
  12. 12. Biosafety In Microbiologicaland Biomedical LaboratoriesBMBLCDC/NIH PublicationSafety “Guidelines”Regulations of InstitutionreceivesNIH fundingCode of Practice and “Gold”Standard in IndustryGold StandardClinical & Research Lab.Lab. Animal FacilitiesBiosafety Conceptshttp://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
  13. 13. Canadian Laboratory Biosafety Guidelineshttp://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/pdf/lbg_2004_e.pdf
  14. 14. •CEN Workshop Agreement (CWA15793)•ftp://ftp.cenorm.be/public/CWAs/wokrshop31/CWA15793.pdf•WHO Laboratory Biosafety Manual•http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf•Sandia Laboratory Biosecurity Handbook•http://www.crcpress.com/product/isbn/9780849364754Other Resources
  15. 15. Philippines Manual of Standards on NationalLaboratory Biosafety & Biosecurity by the Task Force/TWG on thePreparation of Standards on NationalLaboratory Biosafety & Biosecurity asper DP) No. 2006-2500 DOH, National Center for Health FacilityDevelopment, 17 March 2009
  16. 16. Biosafety ConceptsPrinciples of Biosafety Practice and Procedures Standard Practices Special Practices & Considerations Safety Equipment Facility Design and Construction Increasing levels of protection
  17. 17. Principles of BiosafetyBiosafety Levels 1-4 (BSL) Increasing levels of employee and environmental protection Guidelines for working safely in research & medical laboratoryfacilitiesAnimal Biosafety Levels 1- 4 (ABSL) Laboratory animal facilities Animal models that support research Guidelines for working safely in animal research facilities
  18. 18. 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
  19. 19. (2) Safety Equipment 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 systemsBiosafety Concepts
  20. 20. (3) Facility Design andConstruction Secondary Barrier/ Engineeringcontrols Contributes to worker protection Protects outside the laboratory Environment & Neighborhood Ex. Building & Lab design,Ventilation, Autoclaves, Cagewash facilities, etc.Biosafety Concepts
  21. 21. Biosafety Level-1Concepts of BiosafetyBiosafety Level-1 (BSL-1 or ABSL-1) Well characterized agents Agents not known to cause disease (in healthy humanadults; now healthy immunocompetent adults) Prophylactic treatment available Open bench procedures Animals in open cage system or open environment(outdoors) Good laboratory practices
  22. 22. Risk Group 1 Agents E.coli K-12 Transgenic Plants Plasmids Fungi Mold Yeast
  23. 23. 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
  24. 24. Risk Group 2 Agents Human or PrimateCells Herpes Simplex Virus ReplicationIncompetentAttenuated HumanImmunodeficiencyVirus Patient specimens
  25. 25. BSL-2 PracticesConcepts of BiosafetyPractices & Procedures Agents associated w/ human disease Treatment for disease available Agent poses moderate hazard topersonnel and environment Direct contact or exposure Percutaneous exposure Scratch, Puncture, Needle stick Mucus membrane exposure Eyes, Mouth, open cut
  26. 26. BSL-2 Practices Limited access to labwhen work in progress Daily decontamination Mechanical pipetting Lab.coat, safety glassesand gloves required Red bag & sharpscontainers required
  27. 27. BSL-2 Practices (con’t) Biohaz. Sign posted atentrance to lab Label all equipment(incubators, freezers, etc.) TC room – negative air flow Documented training Baseline serology or pre-vaccination may be required
  28. 28. Risk Group 3 Agents HumanImmunodeficiencyVirus Mycobacteriumtuberculosis Coxiella burnetii
  29. 29. Biosafety Level 3Working in High ContainmentBiosafety Level-3 (BSL-3 orABSL-3) Indigenous or exotic agents Aerosol transmission Serious health effects Treatment may or may not exist
  30. 30. BSL-3 Practices Public access NOT permitted Daily decontamination after spill andupon completion of experiment Autoclave required and waste isdisposed at the end of day Required foot activated handwashingsink and controls No sharps unless absolutely necessary
  31. 31. BSL-3 Practices (con’t) Aerosol minimization procedures required Wrap around disposable clothing isrequired. Specialized equipment may berequired depending upon procedures Biohaz. Signs and labels posted Air flow from low hazard to high hazard“Pressure Mapping”
  32. 32. BSL-3 Practices (con’t) Bench top work not permitted Documented training and personnel competencycertification (for BSL-3 procedures) Baseline serology Spills – report immediately and treat accordingly Vaccinations/post exposure protocols and SOP’s,Biosafety Manual, Biosafety Officer
  33. 33. Biosafety Level-4Working in High ContainmentBiosafety Level-4 Builds on BSL-3/ ABSL-3 practices Maximum containment facilities Pressurized Containment Suite BSL-3 + Class III Biosafety Cabinet Chemical decontamination showers Liquid effluent collection / decontamination
  34. 34. Biosafety Level 4 Lassa Fever Virus Ebola HemmorrhagicFever Virus Marburg Virus Herpes B Virus
  35. 35. Biosafety ConceptsWorking in High ContainmentBiosafety Level-4 (BSL-4 or ABSL-4) Dangerous/exotic agents Life threatening disease Aerosol transmission Agents of unknown riskof transmission or health affects No known treatment
  36. 36. General Good Lab Technique Hygienic Practices No Smoking, Eating, Applying cosmetics, lipbalm, contacts Wash hands after procedures Decontaminate lab bench before and afterwork
  37. 37. 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 (MSDS)http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.html
  38. 38. Risk AssessmentIn-Vitro In-Vivo Human ClinicalTrial
  39. 39. Addressing Risk Assessments What is the organism? Is it Wild-type, attenuated, irradiated, orchemically treated? Look at kill data or killcurves. What is the max. concentration, volume,infectious dose? What is the work space like? Aerosolizing procedures? How do they containtheir aerosols?
  40. 40. Risk Assessment (con’t) Are personnel trained? Dopersonnel understand the organism,infectious dose and symptoms? What are their experimentalprocedures? Will they be transporting thematerial? Shipping intra, inter-stateor international? Are they doing tissue culture? Do they have adequate containmentequipment?
  41. 41. Risk Assessment (con’t) Are they doing thiswork in-vivo? Haveyou consulted anddiscussed this with theVets and IACUC todetermine special needsand housing? Waste issues addressed? Pregnancy issues withthe organisms?
  42. 42. Risk Assessment (con’t) Do they share theirTissue Culture room? Do they have more than1 Biosafety Cabinet? Occupational Healthinformed and set up toreceive patient or offercounseling?
  43. 43. Accidental Spills Evacuate area, alert personnel andcordon off so that aerosols maysettle Don PPE; Cover with papertowels and apply bleach (1 partbleach : 9 parts water Allow 15 – 20 min contact time Wipe up working towards center Use tongs if broken glass isinvolvedIs Recombinant DNA involved?
  44. 44. First Aid Measures Splash to Eye or Needlestick Injury Rinse thoroughly for 15 minutes at the eyewash orsink Call Occupational Medicine Call Employee Health Services
  45. 45. Be safe, Be Biosafe, Be alive!Maraming Salamat po!

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