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General Biosafety

General Biosafety. Tassanee Eamkamon Biosafety Professional Armed Forces Research Institute of Medical Sciences TassaneeE@afrims.org 23 March 2010. Objectives. Principle of Biosafety Overview of Biosafety Levels (BSL) and Risk Groups (RG) Biosafty Level 2 Requirement.

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General Biosafety

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  1. General Biosafety Tassanee Eamkamon Biosafety Professional Armed Forces Research Institute of Medical Sciences TassaneeE@afrims.org 23 March 2010

  2. Objectives • Principle of Biosafety • Overview of Biosafety Levels (BSL) and Risk Groups (RG) • Biosafty Level 2 Requirement

  3. Principle of Biosafety • A fundamental objective of any biosafety program is the containment of potentially harmful biological agents. • The purpose of containment is to reduce or eliminate exposure of follows to potentially hazardous agents. - Laboratory workers - Other persons, - Outside environment www.clker.com/clipart-2970.html

  4. Principles of Biosafety • The term "containment" is used in describing: • Safe methods (Practices) • Safety Equipment (Primary Barriers and Personal Protective Equipment) - Facilities Design and Construction (Secondary Barrier) www.pandemicfluonline.com/%3Fp%3D1359

  5. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Biosafety Level?CDC-NIHhttp://www.cdc.gov/OD/OHS/biosfty/bmbl5/BMBL_5th_Edition.pdf

  6. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Biosafety Level (BSL) • Combination • 4 Levels • Each level is specifically appropriate for: - Operations performed • Risk Group and documented or suspected routes of transmission of the infectious agents Safe Practice Safety Equipment Facility Design

  7. BSL 1 • Appropriate for: • Undergraduate and secondary educational training and teaching laboratories • Laboratories in which work is done with defined and characterized strains of viable microorganisms not known to consistently cause disease in normal, healthy humans • Bacillus subtilis • Vaccine strains that have undergone multiple in vivo passages Safe Practice Safety Equipment Facility Design

  8. BSL 2 • Appropriate for: • Clinical, diagnostic, teaching, and other laboratories • Lab work with a broad spectrum of indigenous moderate-risk agents that are present in the community and associated with human disease of varying severity • Lab work with any human-derived blood, body fluids, tissues, or primary human cell lines where the presence of an infectious agent may be unknown • Hepatitis B virus - P. faciparum • Salmonellae -H1N1 Safe Practice Safety Equipment Facility Design

  9. BSL 3 • Appropriate for: • Clinical, diagnostic, teaching, research, or production facilities • Lab work with indigenous or exotic agents: • -with a known potential for aerosol transmission • -may cause serious and potentially lethal infection • Mycobacterium tuberculosis • Chikungunya Safe Practice Safety Equipment Facility Design

  10. BSL 4 • Appropriate for: • Lab work with dangerous and exotic agents which: • -- pose a high individual risk of life-threatening disease • -- may be transmitted via the aerosol route • -- there is no available vaccine or therapy • -Ebola virus • - Hendra and Nipah virus Safe Practice Safety Equipment Facility Design

  11. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Risk Group?

  12. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Risk Group (RG) Risk classification based on: Pathogenicity Modes of transmission Host range Availability of effective preventive measures Availability of effective treatment

  13. Risk Group (RG) 1. WHO (2004) 2. NIH Recombinant DNA Guidelines (USA, 2002) 3. Australian/New Zealand Standard (2002) 4. Canadian Laboratory Safety Guidelines (2004) 5. European Economic Community (2000)

  14. Overview of Biosafety Levels (BSL) and Risk Groups (RG) www.travelpod.com/travel-blog-en...pod.html www.mrjusino.com/science.htm

  15. Overview of Biosafety Levels (BSL) and Risk Groups (RG)

  16. http://www.absa.org/riskgroups/index.html

  17. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Biosafety Level & Risk Group

  18. Overview of Biosafety Levels (BSL) and Risk Groups (RG) WHO 2004: Laboratory Biosafety Manual

  19. Overview of Biosafety Levels (BSL) and Risk Groups (RG) CDC-NIH 2007: Biosafety in Microbiological and Biomedical Laboratories (BMBL) Summary of Recommended Biosafety Levels for Infectious Agents

  20. Overview of Biosafety Levels (BSL) and Risk Groups (RG) CDC-NIH 2007: BMBL Summary of Recommended Biosafety Levels for Infectious Agents

  21. Biosafty Level 2 Requirement Summary of Recommended Biosafety Levels for Infectious Agents

  22. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Biological risk assessments • Provide a guide for the selection of appropriate biosafety levels and microbiological practices, safety equipment, and facility safeguards that can prevent LAIs • Responsibility: Directors and principal investigators of, Institutional biosafety committees (IBC), Animal care and use committees, Biological safety professionals, and Laboratory animal veterinarians

  23. Overview of Biosafety Levels (BSL) and Risk Groups (RG) Risk Criteria for Establishing Ascending Levels of Containment • Infectivity • Severity of disease • Transmissibility • Nature of the work being conducted • Origin of the agent: Indigenous or Exotic Safe Practice Safety Equipment Facility Design caribbean.scielo.org/scielo.php%...26nrm%3D www.topnews.in/scientists-find-w...-2143806 www.rose-bowl-parade.com/dangers.html www.celprogen.com/store/index.ph...46_59_61

  24. Reduce/eliminate risk of infection Exposure Agent Virulence Susceptibility BSL ?

  25. Safe Practice Biosafty Level 2 Safety Equipment Facility Design Standard Microbiological Practices Special Practices Safety Equipment Laboratory Facilities

  26. Biosafety Level 2: Standard Microbiological Practices • Control access to the laboratory. •  Wash their hands after working and before leaving the laboratory. •  Safely handle of sharps. •  Perform all procedures to minimize the creation of splashes and/or aerosols.

  27. Biosafety Level 2: Standard Microbiological Practices •  Decontaminate work surfaces after completion of work and after any spill or splash. •  Decontaminate all cultures, stocks, and other potentially infectious materials before disposal. •  Implement an effective integrated pest management program. Disinfectant http://i.ehow.com/images/GlobalPhoto/Articles/4492263/clorox2-main_Full.jpg bhrcivicgroup.blogspot.com/2009/...hem.html skitterbot.com/blog/%3Ftag%3Drobotics

  28. Biosafety Level 2: Standard Microbiological Practices • Laboratory supervisor must ensure that laboratory personnel receive appropriate training: • Duties • Necessary precautions to prevent exposures • Exposure evaluation procedures. • Personnel must receive annual updates or additional training.

  29. Biosafety Level 2: Standard Microbiological Practices •  Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions.

  30. Biosafety Level 2: Standard Microbiological Practices • Post a sign incorporating the universal biohazard symbol at the entrance to the laboratory. Information must include: • Biosafety level • Supervisor’s name (or other responsible personnel) • Telephone number, • Required procedures for entering and exiting the laboratory • Agent information

  31. Biosafety Level 2: Standard Microbiological Practices Do Not • Eat, drink, smoke, handle contact lenses, apply cosmetics, and store food for human consumption in laboratory areas. • Store food outside the laboratory area. • Mouth pipette.

  32. Biosafety Level 2: . Special Practices • Advised all persons entering the laboratory of the potential hazards and meet specific entry/exit requirements. •  Prepare and adopt a laboratory-specific biosafety manual as policy. The manual is available and accessible.

  33. Biological Safety Manual Goals • Protect employees, the surrounding community and the environment during activities involving potentially hazardous biological agents. • Provide minimum technical safety and occupational health requirements and guidelines for developing and control process for operation involving etiologic agents. • Provide an environment for high quality research while maintaining a safe work place. • Comply with applicable federal, state and local requirements .

  34. Biosafety Level 2: . Special Practices •  Laboratory supervisor must ensure that laboratory personnel demonstrate proficiency in standard and special microbiological practices before working. AFRIMS Department of Enteric Disease Training 2005

  35. Biosafety Level 2: . Special Practices • Provided Laboratory personnel medical surveillance and offer appropriate immunizations. •  Store a baseline serum sample, when appropriate. radiologyinthai.blogspot.com/200...ive.html

  36. Biosafety Level 2: . Special Practices • Place potentially infectious materials in a durable, leak proof container during collection, handling, processing, storage, or transport within a facility. • Decontaminate laboratory equipment routinely. • Decontaminate equipment before repair, maintenance, or removal from the laboratory.

  37. Biosafety Level 2: . Special Practices • Contain, decontaminate, and clean up spills by staff properly trained.

  38. Biosafety Level 2: . Special Practices • Immediately evaluated and treated incidents. • Report all such incidents to the laboratory supervisor. • Provide medical evaluation, surveillance, and treatment and maintain appropriate records.

  39. Biosafety Level 2: . Special Practices •  Conduct all procedures that may generate an aerosol in a BSC or other physical containment devices. •  Do not permit animals and plants not associated with the work being performed in the laboratory.

  40. Biosafety Level 2: Safety Equipment (Primary Barriers and Personal Protective Equipment) • Use properly maintained BSCs (preferably Class II) • Appropriate PPEs • Other physical containment. www.labdepotinc.com

  41. Laminar Flow (LF): • - Product protection (no personnel protection) • - Not for biohazard agents or chemical fumes • Fume Hood: • - Removes toxic chemical (ducting sys./ductless) • - No HEPA filter -> not for biohazard agents • Biohazard Safety Cabinet (BSC) • - Product and personnel protection (not Class 1) ateam.lbl.gov/.../su99/vogel/hoodsketch.jpg web.princeton.edu/.../labsafetymanual/bsc1.jpg

  42. BSC Class I Airflow pattern In at front Exhausted through HEPA to the outside* or into the room. Airflow pattern Supply air inlets and hard-duct exhausted to outside through two HEPA filters in series. III BMBL 5th

  43. BSC Class Airflow pattern 70% recirculated to the cabinet work area through HEPA Exhaust air recirculate to the laboratory or discharged from the building via a canopy connection. II A1 II A2 (A/B3) Airflow pattern Same as II, A1 Exhaust air recirculate to the laboratory or discharged from the building via a canopy connection*. BMBL 5th

  44. Biosafety Level 2: Safety Equipment (Primary Barriers and Personal Protective Equipment) • Remove protective clothing before leaving for non-laboratory • Dispose of or deposit for laundering protective clothing appropriately. • Persons who wear contact lenses in laboratories should wear eye protection.

  45. Biosafety Level 2: Safety Equipment (Primary Barriers and Personal Protective Equipment) • Select glove base on an appropriate risk assessment. Gloves must not be worn outside the laboratory. • Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the laboratory.  • Do not wash or reuse disposable gloves.  • Dispose of used gloves with other contaminated laboratory waste. 

  46. Biosafety Level 2: Laboratory Facilities (Secondary Barriers) • Laboratory doors should be self-closing and have locks. •  Laboratories must have a sink for hand washing. •  The laboratory should be designed so that it can be easily cleaned and decontaminated. Carpets and rugs in laboratories are not permitted.

  47. Biosafety Level 2: Laboratory Facilities (Secondary Barriers) • Laboratory furniture must be capable of supporting anticipated loads and uses. •  Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals. •  Chairs used in laboratory work must be covered with a non-porous material.

  48. Biosafety Level 2: Laboratory Facilities (Secondary Barriers) • Laboratory windows that open to the exterior are not recommended. Otherwise, must be fitted with screens. •  Vacuum lines should be protected with HEPA filters, or their equivalent. Liquid disinfectant traps may be required. flickr.com/photos/70136696%40N00...84133289

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