A Rational and Attainable Approach to Successfully Implementing Biosafety in Laboratory Settings Worldwide. Anticipating Biosecurity Challenges of the Global Expansion of High Containment Biological Laboratories Istanbul, Turkey July 2011 Barbara Johnson PhD, RBP Biosafety Biosecurity International

Biosafety Challenges Lack of funding Lack of funding Lack of reliable/maintained infrastructure Lack of reliable/maintained infrastructure Lack of containment equipment Lack of containment equipment Supply shortages/delayed shipments Supply shortages/delayed shipments Lack of training Lack of training Other? Other? Regardless of these challenges the public health, medical, and R&D mission continues.

BSL-3 Practices Enhance Safety Training and proficiency: good practices prevent exposure Training and proficiency: good practices prevent exposure Control access to the lab: limit people in lab during work Control access to the lab: limit people in lab during work Reducing community spread: designated lab over-clothes stay in the lab; should be decontaminated & laundered by the institute Reducing community spread: designated lab over-clothes stay in the lab; should be decontaminated & laundered by the institute

BSL-3 Practices Enhance Safety Autoclave availability and power: Can we flame loops outside the BSC and place them in a sterile can in the BSC Autoclave availability and power: Can we flame loops outside the BSC and place them in a sterile can in the BSC Sharps cause many lab injuries: Puncture-proof containers near point of use ; alternatives to commercial containers Sharps cause many lab injuries: Puncture-proof containers near point of use ; alternatives to commercial containers Waste decontamination options: autoclave, chemical, burn Waste decontamination options: autoclave, chemical, burn Reducing spill hazard: reusable/sealable container for within-room and room-to-room transport Reducing spill hazard: reusable/sealable container for within-room and room-to-room transport

Primary Containment Considerations BSC: cost, space & power bumps are a reality. BSC: cost, space & power bumps are a reality. Q: Is it infectious via the aerosol route??? Q: Is it infectious via the aerosol route??? risk appropriate PPE (respirator/mask, face shield/goggles/gloves)... respirator reuse? risk appropriate PPE (respirator/mask, face shield/goggles/gloves)... respirator reuse? cleaning surfaces and equipment cleaning surfaces and equipment can a ‘fan box’ (inward airflow, no HEPA) be vented to outside, pilot ongoing in Africa can a ‘fan box’ (inward airflow, no HEPA) be vented to outside, pilot ongoing in Africa flexible film isolators for higher aerosol hazards flexible film isolators for higher aerosol hazards

Adapting BSL-3 Design Features Gas decontamination v surface wipe down for rooms and spaces with i.e. bleach Gas decontamination v surface wipe down for rooms and spaces with i.e. bleach Directional airflow: place wall mounted exhaust fan at end of hall or inside the ‘lab with greatest hazards’ Directional airflow: place wall mounted exhaust fan at end of hall or inside the ‘lab with greatest hazards’ Single-pass air or recirculate air from BSL-3??? Single-pass air or recirculate air from BSL-3??? Air is not recirculated to lower containment levels- assess the risk (can it be HEPA filtered?) Air is not recirculated to lower containment levels- assess the risk (can it be HEPA filtered?) WHO LBM and CDC/NIH BMBL WHO LBM and CDC/NIH BMBL

Adapting BSL-3 Design Features Air changes/hr Air changes/hr was based on labs w/volatile chemicals was based on labs w/volatile chemicals new minimum = 6 ACH for BSL-3 labs (could be less - depends on heat load, activities, is specific to the lab) new minimum = 6 ACH for BSL-3 labs (could be less - depends on heat load, activities, is specific to the lab) Night, weekend, holiday: decrease the conditioning of the air/lights to reduce expense Night, weekend, holiday: decrease the conditioning of the air/lights to reduce expense the lab really should not be ‘turned off’ – overheating, mold, condensation the lab really should not be ‘turned off’ – overheating, mold, condensation

Adapting BSL-3 Design Features N+1 systems: are they needed/which are needed N+1 systems: are they needed/which are needed Systems and parts- local manufacture and installers; expertise is nearby, spares are available Systems and parts- local manufacture and installers; expertise is nearby, spares are available Turnkey container labs: identify mission needs Turnkey container labs: identify mission needs a clean room with lots of HEPAs = $$ and overkill a clean room with lots of HEPAs = $$ and overkill HEPAs need to be annually certified HEPAs need to be annually certified can exhaust air be vented away from public spaces and supply inlets (no re-entrainment) can exhaust air be vented away from public spaces and supply inlets (no re-entrainment)

Adapting Construction BSL2 Laboratories Paint on gypsum board. BSL3 Laboratories Epoxy based paint on gypsum board. Perimeter walls constructed of epoxy based paint on poured in place concrete... high end/high cost- is it needed ABSL3 Rooms Epoxy based paint on poured in place concrete. Concrete because animal carts can damage walls- good SOPs can prevent damage too.

Adapting Construction BSL2 Laboratories Vinyl Flooring Cleanability: Smooth, easily cleanable, soil and stain resistant composite material with integral cove base. BSL3 Laboratories Seamless Welded Vinyl Flooring Same basic characteristics as above. Need for added durability depends on equipment. ABSL3 Rooms Epoxy Resin Flooring As above but resistant monolithic material- extremely durable, esp. with heavy & mobile equipment- what cages are used/lots of stainless?

No “Only One Correct Way”... Biosafety is about risk assessment and planning: prioritize the goals & needs prioritize the goals & needs achieve it by balancing the available tools to reduce risk achieve it by balancing the available tools to reduce risk plan ahead for accident, illness or injury plan ahead for accident, illness or injury Facilities Equipment Practices / Protocols

Thank You Barbara Johnson, PhD, RBP