32 C.F.R. § 627.45   Biosafety level 3.


Title 32 - National Defense


Title 32: National Defense
PART 627—THE BIOLOGICAL DEFENSE SAFETY PROGRAM, TECHNICAL SAFETY REQUIREMENTS (DA PAMPHLET 385–69)
Subpart G—Facilities

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§ 627.45   Biosafety level 3.

(a) General requirements. Each suite used as a laboratory or in which infected animals are housed will, as a minimum, have the following features:

(1) Physical separation from areas which are open to unrestricted traffic.

(2) All entrances to each laboratory or animal room from the nonlaboratory access corridors will be through two sets of doors. A change room or airlock may be incorporated between the doors.

(3) The interior surfaces of walls, floors, and ceilings will be water resistant so that they may be easily cleaned.

(4) All penetrations into the walls, floors, and ceilings should be sealed or capable of being sealed to facilitate decontamination.

(5) A foot, elbow, or automatically operated sink will be located near the exit door to each laboratory or animal room.

(6) An autoclave should be in each laboratory or animal room and will be available to the facility.

(7) A ventilation system that will—

(i) Create directional airflow that draws air into the laboratory through the entry areas.

(ii) Not recirculate laboratory air.

(iii) Discharge the exhaust air from the laboratory to the outside and disperse the exhaust air away from occupied areas and air intakes.

(iv) Exhaust the HEPA-filtered air from Class I or II biological safety cabinets or other primary containment devices directly to the exterior of the laboratory or through the building exhaust system. Exhaust air from the cabinets may be recirculated within the laboratory if the cabinet is tested and certified at least every 12 months. If the filtered cabinet exhaust is discharged through the building exhaust system, it will be connected to this system in a manner (for example, thimble unit connection) that avoids any interference with the air balance of the cabinets or the building exhaust system.

(8) All windows to the facility will be sealed shut.

(9) Appropriate biological safety cabinets or other specialized containment equipment will be provided.

(10) Any vacuum line in the facility will have a HEPA filter and liquid disinfectant trap.

(11) Bench tops that are impervious to water and resistant to acids, alkalis, organic solvents, and moderate heat.

(12) Furnishings that are sturdy and spaces between benches, cabinets, and equipment that are accessible for cleaning.

(13) An eyewash available in or near the laboratory.

(b) Additional animal facility requirements. In addition to the requirements given in §627.44(b) and 627.45(a), all doors to the animal rooms will open inward and be self-closing.

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