Controls in Biosafety I EMD545b Lecture #5

1. Controls in Biosafety IEMD545b Lecture #5 Facility Design & Engineering Controls

2. Facility Design Overview • Goals: • Separation of hazardous work from public spaces (isolation of lab, prevent accidental release) • Controlled airflow • product protection vs. personnel protection • combination of both? • negative pressure, air changes per hour

3. Facility Design Overview • Security/Life Safety Elements • fire rated doors • emergency lighting • Intrusion alarms (motion detectors, etc.) • restricted access (locks, keycard) • lock boxes, locked storage equipment • background checks on personnel

4. Facility Design OverviewSecondary Barriers • BSL1 - BSL4 Laboratories • BSL1 - basic lab • BSL2 - basic lab + aerosol confinement • biosafety cabinet • BSL3 - containment laboratory • 2 door separation from building occupants • BSL4 - maximum containment laboratory • separate building from general research population

5. Biosafety Level 1 Laboratory • Door • Sink • Easily cleaned work surfaces • Impervious bench tops • Sturdy furniture • Windows fitted with fly screens

7. BSL2 Laboratory • BSL1 Lab plus: • lockable doors • chairs covered with non-fabric material • Biosafety cabinets installed as needed • eyewash available • negative airflow, non-recirculation recommended • door closed when work is in progress • autoclave within facility

8. Signs and Labels • Biohazard warning labels on equipment

9. Biosafety Level 3 • “The laboratory has special engineering and design features.” • CDC/NIH BMBL, 5th Ed. 2007

12. BL3 Lab Design Elements • 2 door entry (ante-room, airlock) • Solid easily cleanable surfaces (floor, walls, ceiling) • Coved floors • Sealed penetrations • Lighting flush to ceiling • Hands-free sink near exit door • Eyewash/shower station • Pass through autoclave

13. Wash hands after removing PPE at the hands-free sink

14. Eye/face wash: understand how to use, flush at least weekly, and identify closest station outside the BSL-3 lab (in event of release outside of containment)

15. Signs and Labels • BL3 Door Sign • agent name • entry requirements • emergency contact(s) • lab personnel • safety personnel • campus emergency responders

16. BL3 Lab Design Elements • Negative airflow (into lab) • Most negative at rear of lab • > 12 air changes per hour • -0.05”H20 pressure diff. • Dedicated exhaust fan • Exhaust/supply interlock • Exhaust velocity >3000 fpm, away from intakes, people • Direct exhaust, no recirculation

17. BL3 Lab Design Elements • Airflow monitor, gauges • CO2/N2 feed from outside • Keycard, locked access • Doors open inward, self-closing • Access fixtures from outside space • Door sign at entry • Class II BSC • Canopy exhaust over BSC • Means of communication to areas outside lab

18. BSL-3 Lab Design Exhaust stack velocity > 3000 fpm, away from air intake Supply Fan - interlocked with Exhaust Fan, > 50 ft away from exhaust Exhaust HEPA filter, in accessible location for testing, minimize contaminated ductwork -0.05” to -0.1” H20 pressure diff. at each door

19. BSL-3 Lab Design Dedicated exhaust fan, no recirculation Dedicated supply fan preferred Controlled airflow into the lab Exhaust > supply by 15% or 100 CFM 12 – 15 Air Changes per Hour (constant flow) Visible airflow indicator at each entry Sealed penetrations (non-shrink sealants)

20. BSL-3 Lab Design Positive seal dampers on each side of exhaust filter Positive seal damper on supply air duct(s) Canopy/thimble over biosafety cabinet Audible & visual airflow alarms Pass through auto-clave Class II Biosafety cabinet Centrifuge with aerosol containment

21. BSL-3 Lab Design Lighting flush with ceiling with access from outside containment Gases (CO2/N2) piped into lab from outside containment Solid ceiling and walls Vacuum system HEPA filtered Benches resistant to chemicals used Access to repair of equip. from outer area Monolithic floor with coved wall base

22. BSL-3 Lab Design Emergency back-up power for fans and equipment Bag-in bag-out filter housing Supply HEPA as backflow prevention BSL-3 AG, Canada BSL-3 Ports pre/post exhaust filter for HCHO decon./sampling Trained personnel

23. BSL-3 Lab Design Secure keycard access door Eye Wash and Emergency Shower Biohazard door sign Automatic or hands-free sink near exit Two door entry from hall corridor Backflow prevention on sink Effluent Sterilization Tank (BSL-3 AG/BSL-4)

24. BSL-3 Lab Design Consideration of back-up exhaust fan Potential for separate clean and dirty change anterooms w/ personnel shower Motion detectors, intrusion alarms Consideration of back-up exhaust HEPA Fire sprinklers Phone, fax – to outside Locked boxes, locked equipment (biosecurity)

25. BSL-3 Lab Design Ducts under negative pressure within the building Minimize length of contaminated ductwork Alarms to 24/7 Control Center Contaminated ducts labeled w/biohazard symbol Anteroom or airlock Sealed windows if present Surface mounted electrical outlets Glass break alarms

26. BSL-3 Lab Design Ceilings: similar to walls Wall finishings: enamel, epoxy, acrylic latex Walls: concrete block, cement board, plastic Doors open inward,& self-closing Floors: heat seamed vinyl or poured epoxy

27. Preparation Procedures • Entry Procedures • Verify airflow • Enter ante room • Close outer door • Sign log book • Don PPE • Supplies • Enter laboratory

28. For work in a Biosafety Cabinet • solid-front or wrap-around gown • gloves (double gloving) • face protection (face shield or mask and safety glasses)

29. Use of a HEPA-filtered PAPR for additional protection during high-risk research procedures

30. For work outside a Biosafety cabinet • solid-front or wrap-around gown or jump suit • gloves (double gloving) • face protection (face shield or mask and safety glasses) • Respiratory protection if aerosols are generated

31. Autoclave located within BSL-3 Laboratory All waste from BSL-3 lab must be autoclaved prior to disposal Label autoclaved BSL-3 waste as “Pathological Waste” for incineration

32. BL4 Lab - Max Containment

33. Containment Lab Planning Team • Project managers, engineers, architects, electricians, HVAC, controls, safety, researchers, USERS! • Formal program document of requirements • description of all proposed activities • #’s (personnel occupancy) • major equipment requirements • space allocation • general environmental control criteria • facility controls

34. Containment Lab Planning Team • Questions: • Specific single project? • Future changes, government regulations? • Flexibility in design? • Pathogenic microbes used? • Quarantine areas needed? • Animals? #’s? Species? • Treatment of liquid or air effluents? • Transitional areas needed? • Finishings, Services (water, vacuum, gas, air, etc.) • Commissioning/Verification

35. Communication • Local/state public health offices • Public affairs office • Biosafety Committee • Citizens (neighbors) • Toronto debacle • Winnipeg’s “accident” • CDC (in the shadow of Emory University) • The BU BSL4 Lab

36. Community Design Wish List • HEPA filtered exhaust air • Alarms & supply/exhaust interlock • Emergency back-up power (fan, biosafety cabinets, freezers) • Effluent sterilization system • Pass through autoclave • Shower

37. Community Design Wish List • True airlock • Separate clean (entry) and dirty (exit) anterooms • Glove boxes • Ducted or canopy connected biosafety cabinets • Dunk tanks, pass through autoclaves, facility sterilization system • Backflow prevention

38. Community Design Wish List • Trained architect/planners/builders • Trained research and safety staff • Initial and ongoing commissioning • Written facility policy manual • Emergency procedures known and practiced • Focus on eliminating community exposure • Not in my backyard!

39. Engineering Controls • Primary Barriers • Mechanical devices that minimize exposure • Must be applied before work practices and personal protective equipment

40. Chemical Fume Hood • Room air drawn into front opening • Direct ducted exhaust to exterior of building at roof level • 100 fpm inflow velocity • dilution of toxic, flammable chemicals

41. Class I Biosafety Cabinet • HEPA-filtered fume hood • Protects worker and environment • No product protection • inflow velocity 75 fpm • Exhaust to room or hard-ducted

42. Class II Type A1 Biosafety Cabinet • inflow velocity 100 fpm • 70% air recirculation • Protection of worker, product, and environment

43. Class II Type B2 BSC • Total exhaust BSC • Can use small quantities of chemicals or radioactive materials

44. HEPA-filtered Gloveboxes

45. Animal Care Containment • Cage dumping station • Confinement of pathogenic waste, allergens

46. Clean Bench - Horizontal Flow • Product protection only • Air blown at operator from across work area • Not for use with potential biohazards, cell culture work, or allergens

47. Sharps • Percutaneous exposure risk • employ safe work practices • utilize safe sharp devices • Aerosol risk • work practices, containment equipment for confinement

48. Safe Sharps Devices

49. Sharps with Integrated Shields

50. Safer Products • Mylar wrapped glass capillary tubes • Plastic Vacutainers