Checklist for Design of Bio-Safety Level 1 to 4 Laboratories Background The design of bio-medical laboratories is usually based on 4 different levels

of containment, from the lowest to the highest risk. The design standards differ from country to country, and are often subject to the operational requirement of the operator. In the absence of a national standard for ingapore, at the moment, the following list of design requirements will serve as a simple checklist!guide for designers. Bio-Safety Level 1 This level applies to the most basic laboratory, requiring no special design features beyond those suitable for a well-designed and functional laboratory. "iological safety cabinets are not required. #ork may be done on an open bench top and containment is achieved through the use of practices normally employed in a basic bio-medical laboratory. $hecklist%

& room separated from public areas by a door is required. There are no particular restrictions on locating the facility near public or heavily travelled corridors' however, doors should remain closed. $oatings on walls, ceilings, furniture, and floors should be cleanable. #indows that can be opened should not be near working areas or containment equipment and should be equipped with fly screens. There are no special air handling requirements beyond those concerned with proper functioning of the biological safety cabinets, if used, and those required by building codes. (andwashing facilities must be provided, preferably near the point of e)it to public areas. eparate hanging areas should be provided for street clothing and laboratory coats. *ye wash stations may be required by local statute.

Bio-Safety Level 2 +e)t level of containment. In addition to the requirements of "io- afety ,evel - requirements, the following are required% $hecklist%

The laboratory should be located away from public areas, general offices, and patient care areas. & bioha.ard sign with appropriate information must be posted on the entrance to the laboratory.

,aboratory furnishings and work surfaces should be impervious and readily cleanable. $oat hooks must be provided for laboratory coats near the e)it. &n autoclave must be available in or near the laboratory. ,aboratory doors should be self-closing.

Bio-Safety Level 3 The operational requirements for the "io- afety ,evel / laboratory are substantially greater than those for ,evels - and 0 and the laboratory staff must receive specific training in the safe handling and manipulation of the agents used in this laboratory. & "io- afety ,evel / containment laboratory requires speciali.ed design and construction. The following are required in addition to the requirements for "io- afety ,evel - 1 0 laboratories. $hecklist%

The laboratory must be located away from general work areas and have controlled access from other areas. This is accomplished by entry through a lockable changing room with self-closing doors. & body shower should be provided within the containment perimeter. The laboratory must be held at a negative pressure relative to the surrounding areas at all times such that a directional airflow is created by air ingressing through all entry and e)it areas. The laboratory should be provided with a dedicated supply and e)haust system which is sealed. The air discharged from the laboratory cannot be recirculated back into either the air supply system of the laboratory itself or into the building or adjacent buildings. 2rovided there is a dedicated sealed e)haust system, air may be e)hausted from the laboratory to the e)terior of the building without (*2& filtration. &t the discharge point the e)hausted air must be dispersed away from air intake or populated areas. (owever, when the air is not e)hausted by means of a dedicated e)haust system, it must be passed through a (*2& filtered e)haust before discharging into the main building e)haust air ventilation system. This e)haust housing must be designed to allow in situ decontamination and must pass annual testing and certification by aerosol challenge and scan techniques. & control system must be provided to ensure that the ,evel / laboratory does not become positively pressuri.ed relative to the surrounding area. #hen the supply air is not provided by a dedicated system, air-tight back draft dampers or (*2& filters must be installed in the supply system. The supply must be interlocked with the e)haust system. "iological safety cabinets must be installed in a manner which does not interfere with the air balance of the cabinet or room. Thimble unit connections are recommended. The laboratory must have a dedicated handwashing sink with foot, knee or automatic controls, located near the e)it.

The laboratory must have a pass-through or stand alone autoclave located in the work .one. #here physical constraints preclude the installation of an autoclave, in an e)isting ,evel /, alternative technologies may be used for sterili.ation of contaminated materials. ,aboratory furnishings should be kept to a minimum. #ork surfaces should be impervious, readily cleanable, and resistant to chemical disinfectants. &ll penetrations for services in the floors, walls, and ceiling of the laboratory must be sealed. The air supply!e)haust system should be provided with manual dampers at the room perimeter that may be closed as required to permit gas decontamination. #ater supplied to the laboratory must be provided with reduced pressure back flow preventers. (*2& filters or equivalent should be provided on all ventlines. 3unk tanks may be provided at the containment perimeter. ink and floor drains from this suite should be piped separately to the main building drain and be appropriately labelled. 4loor drains are not generally recommended. Infectious materials must never be placed in sinks or floor drains. &utoclave condensate drains should have closed connections and go directly to sanitary sewer. In animal care facilities for small animals, the disposal of wastes will not differ from other contaminated laboratory materials. ,arge animals producing quantities of infectious wastes require special facilities which must be designed accordingly. 2ortable vacuum pumps must be fitted with in-line (*2& filters or equivalent equipment. +o vacuum lines may e)it the containment perimeter. ,aboratory windows must be sealed and unbreakable. "ackup power should be provided to critical items such as biological safety cabinets, fume hoods , free.ers etc.

Bio-Safety Level 4 The physical and operational requirements of "io- afety ,evel 4 laboratories are highly speciali.ed and any institution undertaking ,evel 4 work must seek e)perienced assistance in developing the lab design and operational protocols. "io- afety ,evel 4 is the highest level of containment and represents an isolated unit functionally independent of other areas. This level of containment requires an air lock for entry and e)it, $lass III biological safety cabinets or positive pressure ventilated suits, a laboratory

support area, and a separate ventilation system in addition to the physical and operational requirements of containment ,evels - to /.

The laboratory must be physically separated from other laboratories or consist of an isolated .one which is monolithic in construction with all penetrations to floors, walls, and ceilings sealed with non-shrinking sealant. The laboratory must be designed to accommodate a minimum of two persons at all times, all laboratory equipment, long term storage of cultures and maintenance of infected animals. *ntry must be through an airlock system with doors that are electrically interlocked. 5anual alarm overrides must be provided. $hange rooms must be contiguous with the containment perimeter of the structure and have a personnel shower and !or chemical shower 6depending on the mode of operation7. &ll drain traps must be kept filled with an effective disinfectant and connected to a liquid waste effluent system. &ll air access to any sewer and ventilation lines must be fitted with (*2& filters or equivalent. &ll gas services must be fitted with (*2& filters, equivalent equipment, or back-flow preventers to prevent egress of contaminated material. The water supply systems for the laboratory must be provided with back-flow preventers. &ll windows must be sealed and provided with break-resistant glass. The laboratory must be provided with a double-door autoclave preferably serviceable from outside the facility. The autoclave should have read-out charts inside and outside the containment laboratory and have operating controls inside the laboratory. 3unk tank6s7 which are chemically resistant and of a suitable si.e for the passage of anticipated laboratory materials may be required for $lass III cabinet lines laboratories. & dedicated handwashing sink with foot, knee or automatic controls must be located at the e)it of each laboratory room in the ,evel 4 laboratory 6not applicable for suit laboratory7. The facility must be equipped with a two-way intercom system. & closed circuit television system should be considered. &ll liquid effluents from the facility must enter a waste effluent treatment system for sterili.ation which is mechanically and biologically monitored.

The facility must be ventilated by an independent, dedicated, sealed supply and e)haust air system which is not recirculated. *)haust air must be passed through at least 0 (*2& filters mounted in series in sealed housings designed to allow in situ decontamination and testing by aerosol challenge techniques. upply and e)haust ventilation systems must be designed to maintain directional 6inward7 airflows and pressure differentials, and interlocked to prevent pressuri.ation in the event of e)haust fan failure. The supply air system must be equipped with a (*2& filter. The facility must be fully equipped with manometers and!or other monitoring devices and audible and visual alarms capable of being monitored by both laboratory and maintenance staff. The laboratory must be provided with $lass I, II or III tested and certified biological safety cabinets which must be installed in a manner that does not interfere with the air balance of the cabinet or room. If a positive-pressure-ventilated-suit type of operation is used, a lifesupport system with full alarming, backup breathing air, emergency power and a chemical shower facility are required. 2ositive-pressure suits must be used whenever agents are worked with outside a $lass III cabinet. &larms, ventilation and other critical systems must be on separate electrical circuits with emergency backup. & laboratory support area should be provided adjacent to the ,evel 4 containment facility for all non-ha.ardous laboratory manipulations.