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B IOLOGICAL S AFETY C ABINET B ASICS

B IOLOGICAL S AFETY C ABINET B ASICS. BEST PRODUCTS · BEST PERFORMANCE · BEST PROTECTION. H ORIZONTAL L AMINAR F LOW C LEAN R OOM. V ERTICAL L AMINAR F LOW C LEAN R OOM. H ORIZONTAL L AMINAR F LOW C LEAN W ORK S TATION. V ERTICAL L AMINAR F LOW W ORK S TATION.

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B IOLOGICAL S AFETY C ABINET B ASICS

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  1. BIOLOGICAL SAFETY CABINETBASICS BEST PRODUCTS · BEST PERFORMANCE · BEST PROTECTION

  2. HORIZONTAL LAMINAR FLOW CLEAN ROOM

  3. VERTICAL LAMINAR FLOW CLEAN ROOM

  4. HORIZONTAL LAMINAR FLOW CLEAN WORK STATION

  5. VERTICAL LAMINAR FLOW WORK STATION

  6. BALANCED LAMINAR AIR FLOW HOOD

  7. NIH-03-112C CABINET (NATIONAL INSTITUTEOF HEALTH) • Class II - Type A • 10 inch - Inflow Supply 80 + 5 fpm • 8 inch opening – Inflow Supply 90 + 5 fpm • Downflow 80 + 5 fpm with a range of 64 to 96 fpm for all readings

  8. NCI-1 (NATIONAL CANCER INSTITUTE) • Class II - Type B1 • 8 inch opening – Inflow Supply 100 + 10 fpm • Downflow 50 + 5 fpm with a range of 45 to 60 fpm for all readings

  9. NSF-49 (NATIONAL SANITATION FOUNDATION) • June 1976 • Committee composed of: • NIH • NCI • CDC • Manufactures • Users • May 1993 changed from a construction specifications in favor of performance criteria

  10. HORIZONTAL LAMINAR FLOW CLEAN WORK BENCH (PRODUCT PROTECTION ONLY) • Unit Components • Unit Air flows • Unit Types • Bench Top • Console • Vertical

  11. NU-201 AIR FLOW

  12. NU-301 AIR FLOW

  13. Filtered Exhaust Air Room Air LabGard 813 Air Flow CLASS I BIOLOGICAL SAFETY CABINET • 100% Exhaust • Inflow velocity 75 fpm minimum • BSL 1 –3 Usage • Personnel protection only • CDC/NIH recommends a glove-port panel for use with small amounts of radionuclides when exhausted • Typical uses today: Toxic powder weighing, necropsy • Maybe thimble/air gap or hard connected to a exhaust system when proper precautions are taken

  14. CLASS I AIR FLOW

  15. CLASS II – TYPE A1 • 30% Exhaust, 70% Re-circulate • Negative pressure plenum (Changed 2007) • Inflow velocity 75 fpm minimum • BSL 1 –3 Usage • Personnel and Product protection • Minute amounts of non-volatile toxic chemicals and radionuclides if canopy/thimble exhausted • Typical uses today: Bacterial, Viral, Fungal, Parasitic

  16. 70% CLASS II – TYPE A1 Console Bench Top

  17. CLASS II – TYPE A2 • 30% Exhaust, 70% Re-circulate • Negative pressure plenum • Inflow velocity 100 fpm minimum • BSL 1 –3 Usage • Personnel and Product protection • Minute amounts of volatile toxic chemicals and radionuclides if canopy/thimble exhausted • Typical uses today: Bacterial, Viral, Fungal, Parasitic, Arbor-viruses

  18. 70% CLASS II – TYPE A2 Console Bench Top

  19. CLASS II – TYPE B1 • 70% Exhaust, 30% Re-circulate • Negative pressure plenum • Inflow velocity 100 fpm minimum • BSL 1 –3 Usage • Personnel and Product protection • Minute amounts of volatile toxic chemicals and radionuclides • Must be hard connected with typical exhaust requirement being 300-500 CFM at 1.0” w.g. • Must have interlocked internal blower with audible and visual alarm for exhaust failure • Typical uses today: Bacterial, Viral, Fungal, Parasitic, Arbor-viruses

  20. CLASS II – TYPE B1

  21. CLASS II – TYPE B2 • 100% Exhaust • Negative pressure plenum • Inflow velocity 100 fpm minimum • BSL 1 –3 Usage • Personnel and Product protection • Small amounts of volatile toxic chemicals and radionuclides • Must be hard connected with typical exhaust requirement being 700-1,200 CFM at 2.0” w.g. • Must have interlocked internal blower with audible and visual alarm for exhaust failure • Typical uses today: Bacterial, Viral, Fungal, Parasitic, Arbor-viruses, Prion, Cytotoxics

  22. CLASS II – TYPE B2

  23. ONE-ON-ONE EXHAUST SYSTEM 10’ Above roof line Make-up Air Supply Stack Contactor Blower Damper (Automated or Manual) Cabinet

  24. Ceiling Ceiling GANGED EXHAUST SYSTEM Stack Make-up Air Supply Contactor Blower Duct CAV Damper (Manual) Cabinet

  25. CLASS III – “GLOVE BOX” • 100% Exhaust Glove Box • Negative Pressure at 0.5” w.g. minimum • Double HEPA Filter Exhaust • BSL 4 • Personnel and Product Protection • Small amounts of volatile toxic chemicals and radionuclides • Must be hard connected with typical exhaust requirement being 50-100 CFM at 0.5 w.g. • Must have negative pressure alarm for cabinet or exhaust failure • Typical uses today: Toxic Powders, BSL 4 Agents

  26. BIOLOGICAL SAFETY CABINET CLASS / TYPES • Class I: Personnel Protection Only • 100% exhaust • Inflow velocity 75 fpm minimum • Class II: Personnel and Product ProtectionType A1 - 30% exhaust, 70% re-circulate • Negative Pressure Plenum (Changed 2008) • Inflow velocity 75 fpm minimum Type A2 - 30% exhaust, 70% re-circulate • Negative Pressure Plenum • Inflow velocity 100 fpm minimum

  27. BIOLOGICAL SAFETY CABINET CLASS / TYPES • Class II: Personnel and Product ProtectionType B1 - 70% exhaust, 30% re-circulate • Negative Pressure Plenum • Inflow velocity 100 fpm minimum Type B2 - 100% exhaust • Negative Pressure Plenum • Inflow velocity 100 fpm minimum • Class III: Personnel and Product Protection • 100% exhaust • Negative Pressure at 0.5” w.g. minimum

  28. NON-VOLITILE TOXIC CHEMICALS & RADIONUCLIDES VOLITILE TOXIC CHEMICALS & RADIONUCLIDES BSL LEVEL OF AGENT USED BSC CLASS I YES YES (1, 3) I - 3 II – TYPE A1 I - 3 YES (1) NO YES II – TYPE A2 I - 3 YES (4) II – TYPE B1 I - 3 YES YES (1, 3) II – TYPE B2 I - 3 YES YES (2) III 4 YES YES (2) RISK ASSESSMENT • Minute Amount • Small Amount • In no instance should the chemical concentration approach the lower explosion limits of the compound. • Type A2 cabinets used for work with minute quantities of volatile toxic chemicals and tracer amounts of radionuclides required as an adjunct to microbiological studies must be exhausted through properly functioning exhaust canopies.

  29. AIRFLOW BALANCEOPTIMIZATION

  30. BIOLOGICAL TESTINGFOR OPTIMAL AIRFLOW BALANCE • Optimized through airflow distribution verified through • Biological Standard Range Tolerance Testing (NSF/ANSI 49) • Biological Wide Range Tolerance Testing

  31. PERSONAL PROTECTION

  32. PRODUCT PROTECTION

  33. CROSS CONTAMINATION

  34. BIOLOGICAL WIDE RANGE PERFORMANCE TESTING

  35. EXHAUST CONNECTIONSFOR CLASS II, TYPE A2 BSC’S • Canopy / Thimble is strongly recommended • Low Exhaust Alarm • Use of flex duct for adjustability • Exhaust volume equals BSC exhaust volume plus air gap volume at 0.3” w.g. • Provide adequate make up air

  36. EXHAUST CONNECTIONSFOR CLASS II, TYPE B1/B2 BSC’S • Direct hard connection is required • Provide gas-tight exhaust damper for decontamination process • Evaluate connection restrictions based on BSC requirements (i.e. exhaust sensor type used) • Provide adequate make-up air for laboratory pressure requirements • Use Concurrent Balance Value from manufacturer to design and balance BSC

  37. CBV DEFINITION Concurrent Balance Value (CBV) is determined by a duct traverse measurement method as specified in ASHRAE Standard 111 – 2008, a minimum of 7.5 duct diameters downstream of a direct connected BSC at its nominal setpoint calibrated using the primary DIM method. The static pressure is measured approximately 2 duct diameters above the BSC. Appropriate filter load and tolerance values are added to accommodate filter loading. The resulting values may be used for design and balance exhaust/supply HVAC Requirements.

  38. BREIF HISTORY • Since the use of the DIM in the early 90’s, differences in measurement results have been noted between duct traverse and BSC face measurement methods • ASHRAE Study Results (1212 – RP) • BSC face measurement is consistent and repeatable • Lack of correlation between methods makes BSC face measurement method suspect for mechanical system design and air balancers • NSF 49 Joint Committee • Reviewed ASHRAE study results and voted to incorporate the CBV into the listing

  39. BSC FACILITY ASSESSMENT • Ceiling Height / Door Width and Height -must accommodate the needs of the user within the constraints of the facility • Personnel movements / Door movements / pass-thru’s / and flow patterns in the facility must be analyzed • Design criteria; BSL 1, 2, 3 or 4 • HVAC - Facility air handling system

  40. FACILITY DESIGN • Location • Isolate the BSC • Reduce traffic flow • Diffuse room air • Move away from airflow ducts • Move away from windows and doors

  41. FACILITY DESIGN • HVAC • BSC’s if exhausted require a constant volume (+/- 5%) • Laboratory balance positive or negative • Laboratory ventilation rates • Class II, Type B cabinets should never be the dedicated exhaust for the Lab. • Spatial and temporal uniform distribution of room air • Review system dynamics, personnel movement, door movement, pass-thrus, etc. • National, Local Code Conformity

  42. PROCESS ASSESSMENT • Process Plan Analysis • Applicable Automation • Applicable facility SOP’s • cGMP Requirement

  43. EXAMPLE OF DATA PROVIDED BY MANUFACTURER

  44. ASHRAE STD. 111:2008 Ak factor = Measured Airflow Rate divided by the velocity Reading of a particular instrument used in its prescribed manner

  45. 1in (25mm) Minimum Existing Ductwork Silicone or Neoprene Sleeve (NuAire Part #NU-940-001 or Equivalent) Band Clamp Band Clamp Butterfly Valve Assembly 1in (25mm) Minimum Apply Silicone on Inside Edge of Butterfly Valve Assembly Direction of Air flow HEPA Filter Hood TYPE B1/B2 DUCT CONNECTION

  46. CABINET / BAS CONNECTIONSFOR CLASS II, TYPE B1/B2 BSC’S • Contacts outputs • Fan Relay • Alarm Relay • Contact input from BAS • Night Setback • Remote Override

  47. BSCTESTINGAND CERTIFICATION TONSF/ANSI 49 ANNEX F

  48. PRIMARY TESTS • HEPA Filter Leak Test

  49. PRIMARY TESTS • Downflow Velocity Profile Test

  50. PRIMARY TESTS • Inflow Volume / Calculated Velocity Test

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