General Requirements for a BSL34 Laboratory Mircea Panait

General Requirements for a BSL-3/4 Laboratory Mircea Panait, Ovidiu Ciungradi, Adrian Onu, Dorel Lucian Radu

Classification of infective microorganisms by risk group ► Risk group 1 (no or very low individual and community risk) ► Risk group 2 (moderate individual risk, low community risk) ► Risk group 3 (high individual risk, low community risk) ► Risk group 4 (high individual and community risk) § A microorganism that is unlikely to cause human or animal disease. § A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. § Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited. § A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. § Effective treatment and preventive measures are available. § A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. § Effective treatment and preventive measures are not usually available.

National or regional classification of microorganisms by risk group Pathogenicity of the organism ► Mode of transmission and host range of the organism ► § § ► Local availability of effective preventive measures § § § ► Existing levels of immunity in the local population Density and movement of the host population Presence of appropriate vectors Standards of environmental hygiene Prophylaxis by immunization or administration of antisera Sanitary measures (food and water hygiene) Control of animal reservoirs or arthropod vectors Local availability of effective treatment § Passive immunization § Post exposure vaccination § Use of antimicrobial, antiviral and chemotherapeutic agents

Relation of risk groups to biosafety levels, practices and equipment Risk Group Biosafety Level Laboratory Type Laboratory Practices Safety Equipment 1 Basic – Biosafety Level 1 Basic teaching, research GMT None; open bench work 2 Basic – Biosafety Level 2 Primary health GMT plus services; diagnostic, protective clothing, research biohazard sign Open bench plus BSC for potential aerosols Containment – Biosafety Level 3 As Level 2 plus special clothing, controlled access, directional air flow BSC and/or other primary devices for all activities As Level 3 plus airlock entry, shower exit, special waste disposal Class III BSC, or positive pressure suits in conjunction with Class II BSCs, doubleended autoclave (through the wall), filtered air 3 4 Maximum containment – Biosafety Level 4 Special diagnostic, research Dangerous pathogen units

Summary of biosafety level requirements (1) Biosafety level 1 2 3 4 Isolation of laboratory No No Desirable Yes Room sealable for decontamination No No Yes Ventilation: ► inward air flow No Desirable Yes ► mechanical via building system No Desirable Yes No ► mechanical, independent No Desirable Yes ► HEPA filtered air exhaust No No Desirable Yes Double-door entry No No Yes Airlock No No No Yes Airlock with shower No No No Yes Anteroom No No Yes No Anteroom with shower No No Desirable No Effluent treatment No No Desirable Yes

Summary of biosafety level requirements (2) Biosafety level 1 2 3 4 Autoclave: ► on site Yes Yes ► in laboratory room No No Desirable Yes ► double-ended No No Desirable Yes No Optional Yes No Yes, in conjunction with suit laboratories Desirable Yes, in conjunction with cabinet laboratories Biological safety cabinets: ► ► ► Class III No No Desirable No

BSL-4 project or facility can operate correctly and in safe condition if we have: A good design, engineering, construction and validation of the installation. ► A trained personnel and good procedure system. ► A good maintenance team which ensure the well state of the installation. ►

General considerations regarding BSL-4 laboratory – from the outside BSL-4 design features include the following: ► All seams, joints and doors are sealed to make the building airtight. You can not open a window. Air does not flow in or out under the doors. ► Air is pumped in and out of the building through a filtration system that catches the tiniest microscopic particles, including bacteria and viruses. ► All air ducts are welded stainless steel and tested to be airtight. ► Inside many BSL-4 facilities, laboratories are surrounded by buffer corridors that help protect the labs in the event of bombing attack from outside. ► Features such airlocks, fumigation chambers, disinfectant “dunk tanks” and waste water treatment systems ensure that absolutely everything that leaves a BSL-4 laboratory is decontaminated.

1. 2. 3. 4. 5. 6. 7. 8. A security checkpoint at the entry to the site A secured perimeter around the building A buffer between the building and parking areas, drop-off zones On-site 24 -hour surveillance An additional vehicle checkpoint for lab employees, visitors A secured entryway, including security guards, surveillance cameras, an intercom system and card access readers A delivery vehicle inspection area The building also contains numerous safety and security measures throughout

General considerations regarding BSL-4 laboratory – interior security Once pass outside security, BSL-4 lab workers must pass an interior security station ► Security measures will include combinations of the following: ► § Extensive background checks prior to employment for everyone who works in the building § Guards who check everyone’s identification and credentials § Special identification cards that are scanned to provide an electronic record of who goes in and out, and when § Identifications devices such as retinal or fingerprint scanners

Scouring the air – HEPA filter and filtration inspection verification

Changing room

Inside the lab Entries and exits have double-door airlocks ► Work surfaces are regularly decontaminated ► Researchers are vaccinated against the pathogen they are studying ► All solid and liquid waste is decontaminated by heat sterilization, gaseous sterilization or liquid disinfectant ►

Biocontainment Suits and Biosafety Cabinets The airtight, pressurized suits have dedicated life support systems that include air compressors, alarms and emergency backup air tanks and a HEPA air filtration system ► Work stations called biosafety cabinets serve as additional barriers ► Different type of biosafety cabinet can be used (Class II or III) ►

Decontaminating Shower

Community and Environment