§ 627.46 - Biosafety level 4.

The engineering controls within the facility must provide absolute biological containment. All procedures with etiologic agents requiring this biosafety level of facilities, equipment, and procedures must be conducted either in Class III biological safety cabinets, or in a facility that is designed for the use of a personal positive pressure suit as described in §627.46(b) in conjunction with Class I or II biological safety cabinets.

(a) General requirements. The facility will have the following features:

(1) A separate building or a clearly demarcated and isolated area within a building which incorporates positive personnel control for access.

(2) All entrances from access corridors incorporate an inner and outer change room.

(3) Inner and outer change rooms separated by a shower facility.

(4) A double-doored autoclave, fumigation chamber, or ventilated airlock for passage of all items which do not enter the facility through the change room.

(5) Interior surfaces of walls, floors, and ceilings resistant to water and chemicals to facilitate cleaning and disinfecting.

(6) Walls, floors, and ceilings of the facility constructed to form a sealed internal shell which facilitates fumigation and is animal and insect proof.

(7) All penetrations into the walls, floors, and ceilings sealed.

(8) All liquid drains in the facility connected directly to a liquid waste decontamination system.

(i) Holding tanks collecting waste from sinks, biological safety cabinets, floors, and autoclave chambers provide decontamination by heat treatment.

(ii) Holding tanks collecting waste from shower rooms and toilets provide decontamination by heat or chemical disinfectant methods.

(9) Sewer and other ventilation vents contain in-line HEPA filters.

(10) Internal facility appurtenances (for example, light fixtures, air ducts, and utility pipes) arranged to minimize the horizontal surface area on which dust can settle.

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

(12) Self-closing and lockable access doors.

(13) A ventilation system that—

(i) Is dedicated to the facility and provides fresh air meeting American Society of Heating, Refrigerating, and Air Condition Engineers, Inc. (ASHRAE) Standard 62.

(ii) Maintains a negative pressure differential and assures flow inward from areas outside of the facility toward areas of highest potential risk.

(iii) Has manometers or magnehelic gauges to provide, sense, and display pressure differentials between adjacent areas maintained at different pressure levels. An alarm will sound when the pressures fall below acceptable levels.

(iv) Has the air supply and exhaust interlocked to ensure that exhaust failure or reduction will not allow the air pressure in the area to become positive to the adjacent areas.

(v) Does not recirculate exhaust air.

(vi) Is HEPA-filtered and discharged to the outside, dispersing the exhaust air away from occupied areas and air intakes.

(vii) Has the HEPA filters on the exhaust located as near to the rooms as is practicable.

(viii) Has the filter chambers designed to allow in-place decontamination before the filters are removed and to facilitate certification testing.

(ix) Contains prefilters and HEPA filters in the air supply system to protect the supply air system should air pressures become unbalanced.

(x) Exhausts the HEPA-filtered air from Class I or II biological safety cabinets directly into the laboratory or to the exterior of the building. If the HEPA-filtered exhaust from these cabinets is recirculated, the cabinets are tested and certified every 6 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.

(xi) Passes the treated exhaust air from Class III biological safety cabinets through two sets of HEPA filters in series to the exterior of the facility through the laboratory exhaust air system.

(14) Windows (if present) sealed shut and breakage resistant.

(15) Has a double-doored autoclave for decontaminating materials passing out of the facility. The autoclave door that opens to the area external to the facility is sealed to the outer wall and automatically controlled so that it can only be opened after the autoclave sterilization cycle has been completed.

(16) Has a pass-through dunk tank, fumigation chamber, or an equivalent decontamination method for materials and equipment that cannot be autoclaved.

(17) Has central vacuum systems (if present) that—

(i) Do not serve areas outside the facility.

(ii) Have an in-line HEPA filter placed as near as practicable to each use point or service cock.

(iii) Have filters designed to allow in-place decontamination and replacement.

(18) Liquid and gas services to the facility provided with protective devices that prevent backflow.

(b) Additional requirements for personal positive pressure suit areas. If personal positive pressure suits are worn in lieu of using Class III biological safety cabinets for containment, a special suit area will be provided. The suit area will provide the following, in addition to the requirements stated in § 627.46(a):

(1) An exhaust system dedicated to that area that provides filtration by two sets of HEPA filters installed in series. This system will be backed up by a duplicate filtration unit, exhaust fan, and an automatically starting emergency power source. The ventilation system will maintain the suit area under negative pressure relative to the surrounding areas.

(2) An entry area consisting of an airlock fitted with airtight doors.

(3) A chemical shower to decontaminate the surface of the personal positive pressure suit upon exit.

(4) An air supply and distribution system to support the life support system of the personal positive pressure suits.

(5) Emergency lighting and communications systems.

(6) Sealed penetrations into the internal shell of the area.

(7) A double-doored autoclave to decontaminate waste materials to be removed from the suit area.

(c) Additional laboratory requirements. In addition to those given in § 627.45, if water fountains are provided, they will be foot operated and located in the facility corridors outside the laboratory.

(d) Additional animal facility requirements. In addition to those requirements given in § 627.45, all animal facility external doors will be self-locking.