APPENDIX D Biological Safety Laboratories

Transcription

1 APPENDIX D DESIGN GUIDE FOR BIOLOGICAL SAFETY LABORATORIES JUNE 2010 REVISION The design guidelines presented here pertain to biological research laboratories where potentially harmful microbial agents or recombinant DNA vectors and hosts are used or studied. Such Biological safety laboratories are designed to help maintain containment appropriate to the hazard level that each agent or class of agents presents. The primary source documents for the general requirements of containment laboratory design are Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5 th or later edition (Health and Human Services Centers for Disease Control) and the NIH Guidelines for Research Involving Recombinant DNA Molecules. Risk assessment, user needs, and standards derived within the industry are the primary drivers for design and construction details. Budgetary considerations may drive the decision to construct a containment laboratory and may also limit the laboratory scope or size, but budget limitations mustshall never be a reason to limit or decrease the containment or safety features of a containment laboratory during the design or construction processes. The campus Biological Safety Officer is responsible for developing the risk assessment and for guiding design and construction so that the facility containment capability is consistent with the risk assessment and with the proposed research. --Biological Safety Level 1 (BSL1) laboratories exclusively handle agents that present minimal hazard to humans, plants, animals, or the environment. These laboratories are usually designed with minimal containment systems and equipment. In BSL1 laboratories containment requirements are met almost exclusively by the work practices of the user. Nearly all BSL1 work can be performed on the bench top. If required, significant product protection is usually provided by clean benches or biological safety cabinets. --Biological Safety Level 2 (BSL2) laboratories provide higher level containment systems and equipment. BSL2 labs are intended to handle agents that can cause disease in humans, animals, or plants but that may not infect target organisms easily or cause serious disease. These agents do not normally pose a significant hazard to the community including to adjacent labs and public areas within the building. A Class II Type A2 biological safety cabinet is the central engineering aerosol containment control at BSL2, and procedures that do not generate aerosols can usually be performed on the bench top. --Biological Safety Level 3 (BSL3) laboratories are designed for containment of indigenous or exotic agents that can cause serious, possibly life-threatening disease in humans, animals, or plants and can often infect by aerosol exposure. Human infectious agents normally handled at BSL3 usually present a significant hazard to the laboratory user and to the laboratory area where the work is being done, including adjacent laboratories and public spaces within the building, but rarely to the wider community except for (a) some agricultural pathogens and (b) large-scale (>10 liters) culture of human pathogens normally handled at BSL2. Because of the aerosol hazard all open work in a BSL3 laboratory is performed in a biological safety cabinet, and the 1

2 laboratory design provides significant containment to protect the user, the community, and the environment from biohazardous materials. Besides the biological safety cabinet, the most important containment features in a BSL3 laboratory are a powerful redundant single-pass air exhaust system that maintains a strong negative air flow under all conditions, and HEPA filtering of exhaust air (in most BSL3 laboratories). Wall, ceiling, and floor penetrations are limited to those required for laboratory function and they are carefully sealed to contain gaseous decontaminating agents. The BSL3 laboratory is a purpose-designed and constructed facility that requires specific features constructed in specific ways with specific commissioning requirements. An incorrectly designed or constructed BSL3 laboratory may never be usable for its intended purpose. --Biological Safety Level 4 (BSL4) laboratories are highly specialized facilities intended for work with exotic infectious agents that are capable of causing serious, often lethal human disease and for which vaccines or therapies are rarely available. BSL4 construction and containment requirements are exceedingly elaborate and are beyond the scope of this document. BASIC DESIGN CONSIDERATIONS FOR ALL BIOLOGICAL SAFETY LABORATORIES All biological safety laboratories mustshall be designed to be easy to clean. Floors and walls mustshall be durable and liquid tight. In BSL 2 laboratories, drop ceilings mustshall use smooth, cleanable tiles (mylar face with smooth surface or equivalent). If the risk assessment permits, the walls of multiple rooms within a BSL2 laboratory suite may not be required to extend to the structural deck above, but the perimeter walls of the suite mustshall be full height and extend to the deck. Laboratory furniture and casework should be ergonomically designed. Fixed casework will be sealed and caulked to the walls and floors during installation to facilitate cleaning and prevent vermin from entering. Chairs and other furniture used in laboratory work mustshall be covered with a smooth, non-fabric material that can be easily cleaned and decontaminated. Protect exposed corners and walls from damage by carts and portable equipment. Emergency eyewashes will be provided in all BSL1, 2, and 3 laboratories. All eyewashes shall be plumbed to drain or installed over a sink. Eyewashes shall deliver potable water and mustshall be installed in accordance with Section An emergency eyewash/safety shower will be located close to areas where there is a risk of a splash to the body. Provide an inward flow of air from rooms/areas of low hazard into rooms/ areas of higher hazard without recirculation to spaces outside of the lab. For BSL2 laboratories provide a locked storage area in the building for medical waste interim storage, and provide an autoclave in the building. Provide storage for chemical disinfectants, such as household bleach, ethanol, and other disinfectants as determined by the risk assessment. 2

3 BIOLOGICAL SAFETY CABINETS Nomenclature, features, and applications. The type(s) of biological safety cabinet that should be chosen for new or remodeled biological safety laboratories depends entirely on project needs and risk assessment. The National Sanitation Foundation/ANSI Standard 49 (2002) groups biological safety cabinets into Classes I, II, or III and within Class II Types II-A1, II-A2, II-B1, and II-B2. All of the Classes and Types are in use at UC Davis but Class I and true Class II Type A1 biological safety cabinets (75 fpm face velocity, positive pressure contaminated plenums) are obsolete and should never be included in new or remodeled UC Davis laboratories. Class III biological safety cabinets are typically supplied as glove boxes which require two exhaust HEPA filters and have extremely limited application outside of BSL4 containment. Do not provide a Class III biological safety cabinet without authorization from the Biological Safety Officer. The remaining biological safety cabinet Classes and Types include: Class II Type A2. This is the standard biological safety cabinet used in most BSL2 and BSL3 laboratories at UC Davis and elsewhere. It is also widely used at BSL1 for non-biohazardous cell culture. Relevant featuresclass II Type A2 shall include the following: 100 fpm face velocity Negative pressure contaminated plena, or positive pressure contaminated plena enclosed within negative pressure plena 70% of the air recirculates within the cabinet (30% is exhausted) Class II Type A2 biological safety cabinets may be constructed to recirculate HEPA-filtered exhaust air back into the laboratory or they may be supplied with an air gap (aka thimble or canopy) requiring exhaust ducting to the exterior of the building. The air gap version should be never be installed without the required ducting because the exhaust HEPA filter is exposed and vulnerable to unseen damage that could result in an undetected breach of containment. Volatile chemicals and non-volatile radionuclides may only be used in minute quantities in a Class II Type A2 biological safety cabinet that is connected to the building exhaust via an air gap. Volatile chemicals may not be used at all in a recirculating biological safety cabinet without a ducted exhaust. Recirculating Class II Type A2 biological safety cabinets should not be chosen for new or remodeled BSL2 or BSL3 laboratories without Biological Safety Officer approval. Recirculating cabinets are used primarily to accommodate new projects in existing laboratories that were not originally outfitted with a biological safety cabinet. Class II Type B1. Class II Type B1 biological safety cabinets recirculate only 30% of the intake HEPA-filtered air into the work space, and they exhaust 70% via the rear grill, which allows greater use of volatiles, radionuclides, and toxic chemicals than does the Class II Type A2 biological safety cabinet as long as such work is confined to the rear of the biological safety cabinet work space. Relevant featuresclass II Type B1 shall include the following: 3

4 100 fpm face velocity Negative pressure contaminated plena, or positive pressure contaminated plena enclosed within negative pressure plena 30% of the air recirculates within the cabinet (70% is exhausted) Class II Type B1 biological safety cabinets must shall be hard ducted, usually to an independent exhaust system with the exhaust fan placed just prior to the stack. They must shall also be equipped with alarms to warn the user of an exhaust fan failure, and with an interlock to shut down supply air rapidly if the exhaust fails. The primary advantage of the Class II Type B1 over the Type B2 (discussed below) is that the Type B1 may be more easily integrated into a room air exhaust system but either of the Type B biological safety cabinets can be challenging in this regard. Unless the user has a specific need for a Class II Type B1 biological safety cabinet the Provide a Class II Type A2 or B2 biological safety cabinetare better choices. Do not provide a Class II Type B1 biological safety cabinet without authorization of the Biological Safety Officer. If a Class II Type A2 or B2 cannot be provided, consult the University s Representative for authorization from the Biological Safety Officer to provide a Class II Type B1 biological safety cabinet. Class II Type B2. Class II Type B2 ( total exhaust ) biological safety cabinets exhaust 100% of the supply air through a HEPA filter to the outside without recirculation within the biological safety cabinet. These cabinets mustshall always be hard ducted to a dedicated exhaust system. As such, they resemble a chemical fume hood-biological safety cabinet hybrid in function. Toxic and volatile chemicals and non-volatile radionuclides may be used in Class II Type B2 biological safety cabinets in conjunction with microbiological work. Small amounts of volatile radionuclides may be also be used in these cabinets, provided the Radiation Use Authorization has an approved variance allowing for such work. In a BSL2 laboratory Class II Type B2 biological safety cabinets should not be installed in lieu of providing a standard chemical fume hood. Chemicals used in Class II Type B2 biological safety cabinets mustshall not cause damage to the HEPA filter, filter housings, interior surfaces, or gaskets and this requirement mustshall be discussed with the user during design development. Relevant featuresclass II Type B2 shall include the following: 100 fpm face velocity Negative pressure contaminated plenums, or positive pressure contaminated plenums enclosed within negative pressure plenums 100% of the intake air is exhausted without recirculation within the biological safety cabinet Class II Type B2 biological safety cabinets must shall be hard ducted, always to an independent exhaust system with the exhaust fan placed just prior to the stack. When used in BSL3 laboratories, these biological safety cabinets must shall be equipped with redundant exhaust fans and must shall be equipped with emergency power to the exhaust fans. Alarms to warn the user 4

5 of an exhaust fan failure, and an interlock to shut down supply air rapidly upon exhaust failure must shall also be provided. A redundant exhaust fan system is required for Class II Type B2 biological safety cabinets used in a BSL3 laboratory, and a redundant system may be required for these cabinets in a BSL2 laboratory if the risk assessment so indicates, consult the University s Representative. Biological Safety Cabinet purchase and certification. New Biological Safety cabinets purchased for use at UC Davis mustshall be designed and tested to the most recent edition of NSF/ANSI Standard 49, and must shall also be solidly constructed so that internal spaces and plena do not distort if the floor is uneven. Currently the only mmanufacturers whose biological safety cabinets are routinely approved by EH&S for purchase at UC Davis include Baker (preferred), LabConco (Delta and Logic series and successors), Forma/ThermoFisher, and NuAire, or equal. Consult the University s Representative for advance review by Tthe Biological Safety Officer will review in advanceof any other proposed biological safety cabinet purchase. to determine whether the proposed unit is suitable for use at UC Davis. After installation but before first use all biological safety cabinets must shall be certified to NSF/ANSI Standard 49 (2008 and later revisions) specifications by technicians accredited by NSF under that standard. Biological safety cabinets mustshall also be certified annually thereafter, and any time the cabinet is moved more than one inch (2.5 cm), even if it is then returned to the original position. Biological safety cabinets must also be recertified after any internal repair. Laminar Flow Clean benches. Clean benches use HEPA-filtered air flowing over the work area and exhausted via the front of the enclosure to keep products free of airborne contaminants. They offer no protection to the user and in fact expose the user directly to air flowing over the products at fpm. They are inappropriate for any work involving hazardous materials. Clean benches should shall not be provided. in new or remodeled facilities without the concurrence of the Biological Safety Officer. FurtherGeneral notes: In the absence of specific information regarding biological safety cabinet requirements, provide stainless steel exhaust duct work, external exhaust fan and stack, control valve and controller to support the addition of at least one Class II Type A2 canopy-connected biological safety cabinet in each new laboratory. The UC Davis Biological Safety Administrative Advisory Committee does not recommend the Biological safety cabinets shall not use of ultraviolet (UV) light as a decontamination method nor shall a UV light be provided in existing cabinets. in biological safety cabinets and biological safety cabinets installed on campus should not be provided with a UV light. Natural gas, compressed air, or house vacuum shall not be plumbed to biological safety cabinets. Biological Safety Cabinet Placement 5

6 Locate the biological safety cabinet at least six feet from doors and high-traffic areas and so that air supply diffusers do not affect airflow at the biological safety cabinet face. Provide ( low velocity diffusers preferred). Provide at least 12 inches of clearance above the biological safety cabinet for testing and decontamination of HEPA filters. Install six inches out from the rear wall to allow for cleaning. Ensure that adequate electrical power is available within six feet of the biological safety cabinet. BASIC LABORATORY DESIGN FOR BIOLOGICAL SAFETY LEVEL 3 Under NIH standards, the laboratory design professional uses the current edition of the BMBL as the basis of design. See Section (Laboratory Equipment) for more information. BSL3 laboratory planning must include the campus Biological Safety Officer and a qualified BSL3 specialist commissioning agent from the outset and during all stages of design development and construction. The design professional and the Biological Safety Officer work closely with the commissioning agent to ensure that all containment systems are designed correctly and are later tested to function as intended, which helps greatly to avoid design and construction errors and to avoid project completion delays and overruns. BSL3 laboratories for which specific scientific projects have not yet been identified mustshall generally be designed to be as versatile as possible to accommodate a wide spectrum of potential future activities with minimal remodeling. The following sections conform to the 5 th edition BMBL provisions for Biosafety Level 3 laboratory facilities (secondary barriers). Text in boxes is from the BMBL. Text that follows each box is the design guide provisions corresponding to the BMBL requirement. 1. Laboratory doors must be self-closing and have locks in accordance with institutional policies The laboratory must be separated from areas that are open to unrestricted traffic flow within the building The laboratory must be separated from areas that are open to unrestricted traffic flow within the building Access to the laboratory is restricted to entry by a series of two self-closing doors A clothing change room (anteroom) may be included in the passageway between the two self-closing doors Doors A. Solid doors required throughout the facility. 6

7 B. A window of up to 50% of the door area may be included in any BSL3 suite door; such a window should be included in the last door between the anteroom complex and the main laboratory. C. Self-closing with heavy-duty door hardware should be of high quality to provide a high degree of adjustability to close doors properly for rooms with +/-0.10 inches w.c. differential pressures. D. Locking. Provide standard key locks and security locks such as card key, at first anteroom door from public area and at each laboratory door in a multiple laboratory suite. E. Open inward. Inward opening doors are required for animal BSL3 laboratories and are desirable for standard BSL3 laboratories because they are easier to open if exhaust flow becomes deeply negative. Sliding doors are never allowed because of the complex frame surfaces that may be impossible to cleannot acceptable. F. Have required fire ratings. G. Doors and frames of solid finish construction. Animal room door tops and bottoms should be flat and smooth, without recessed areas, to prevent vermin harborage. H. Door openings sized to allow passage of large equipment. I. Wall-frame connection to be made air tight at time of frame installation. Door frames mustshall be embedded in silicone sealant and caulked thoroughly around the outside seam and willshall be inspected prior to installation. J. Install non-sealing door sweep such as hair sweeps on door between anteroom and corridor to exclude crawling insects and vermin but to permit airflow. J.K. All door sealants willshall be applied before the commissioning agent s room integrity testing. K.L. Panic door hardware shall be surface-mounted externally, not contained concealed within the door. The door frame should not be drilled to accommodate panic hardware bar ends fittings to accommodate the bar ends may be attached externally to the frame if the fastener holes are sealed with silicone during installation. Location A. BSL3 suites mustshall be located away from public areas, separated from unrestricted traffic. B. Locate the BSL3 interior to the building C. No entry into anterooms from the outdoors (dirt and contamination problems). D. The BSL3 laboratory complex mustshall be located away from areas that could impact directional airflow or differential pressure maintenance. Elevators, exterior doors, labs with variable air volume systems or night set-backs, exterior walls with high wind load or temperature swing can cause unacceptable pressure fluctuations. E. The BSL3 laboratory complex should be located in one of the top two floors of the building if the mechanical systems are to be installed outside on the roof, or be sited immediately below a penthouse mechanical systems support space at least as large as the laboratory suite footprint. This will minimize dedicated contaminated exhaust 7

8 duct runs and allow easy access for mechanical systems maintenance and for changing light bulbs from outside of containment. Animal BSL3 facilities may be located as necessary to facilitate animal care requirements but support space mustshall be readily accessible from outside of containment. F. If possible, provide a separate equipment room within the containment envelope to isolate heat load such as supercold freezers and high hazard equipment such as centrifuges, or a shared prep room within the lab. Security A. Access to the BSL 3 building or BSL 3 laboratory complex shall be controlled. A security system should shall be installed to limit access and to record entry with time, date and person. Card scan, key-pad entry with codes unique to each worker, or a biometric system such as palm or iris scan can be used. B. All BSL3 anteroom and laboratory door keys shall be off-master in order to provide added security and to preclude accidental entry by unauthorized persons. All keys to be in the custody of the principal investigator, laboratory director, or other designated individual C. All equipment, except biological safety cabinets, mustshall be lockable D. Lockable equipment should shall be special-ordered with unique locks, and all keys to be placed in the custody of the principal investigator. E. A video surveillance system may be required depending on a security risk assessment, consult the University s Representative. If needed, video cameras should shall be placed to record persons using the access systems and to provide surveillance of corridor activity, storage units such as freezers, work areas, and exits including decontamination rooms and emergency exits as well as normal egress routes. Cameras in the biocontainment area should shall be mounted inside sealed enclosures that are only accessible from outside of containment. F. Consult the University s Representative for Oother security measures to be provided according to the risk assessment and agency requirements. as These will be determined during the design phase. 2. Laboratories must have a sink for hand washing. The sink must be handsfree or automatically operated. It should be located near the exit door If the laboratory is segregated into different laboratories, a sink must also be available for hand washing in each zone Additional sinks may be required as determined by the risk assessment. Sinks and drains A. Hand washing sinks shall be located in each BSL3 work area room near the exit. 8

9 B. Hand washing sinks shall also be provided in at least the dirty change room of the anteroom complex. Other anteroom sink locations in decreasing order of preference are clean change room, shower room, entry room. C. All sinks to dispense potable water. D. Isolate potable water supply in the BSL3 complex from potable water supply elsewhere in the building. E. Sinks in the BSL3 laboratories and in the dirty change anteroom mustshall be either hands-free or automatically operated. The preferred hands-free alternative is with foot pedals placed close to the floor and just exterior to the cabinet, with mixing valve integral with the pedals. Photocell actuated hands-free operation is a nonpreferred alternative because of potential undetected leakage in the wall-mounted mixing valve that can damage adjacent walls and breach containment. F. Sinks in the anteroom complex other than in the dirty change room may use hand operated faucets. G. A wall-mounted paper towel dispenser and a wall-mounted hands-free soap dispenser should be installed above each sink. H. Hot & cold water from a pre-mixing faucet or mixing valve as noted above. I. Backsplash is oversized and coved to the bench top to facilitate cleaning. J. Sinks mustshall have disinfectant/chemical-resistant traps. K. Drains from the BSL3 suite mustshall go directly to the sanitary sewer line and not intersect with other drains from outside of containment. Sink and other trapped fixtures serving the BSL3 suite should be a minimum of 4 deep. Refer to project drawings and specifications for requirements. L. All exposed drain pipes upstream of the sanitary sewer line connection to be labeled with the universal biohazard sticker and with the notation that the effluent comes from a BSL3 laboratory. A stenciled biohazard symbol every three feet on all visible and accessible faces of the pipe is required. Plumbing A. All penetrations are perpendicular to the surface and are caulked to be gas tight. No penetrations that are not part of the immediate BSL3 suite operations requirement are permitted. B. All penetrations are sealed with non-rigid, non-shrinking fire retardant sealant followed by durable silicone sealant. Escutcheons and other finishing plates should not be installed until the biological safety officer verifies containment envelope integrity. C. All pipes into the BSL3 suite from hollow walls are secured inside the wall to prevent movement. D. Pipes external to solid walls mustshall run vertically and be caulked between the pipe and the wall. E. Provide fixtures resistant to bleach corrosion and other disinfectants and decontaminants (e.g., vaporized hydrogen peroxide VHP). 9

10 F. Back-flow prevention on all faucets, even if on industrial water, shall be provided with the use of reduced pressure backflow preventers. G. Locate water supply control shutoff outside biocontainment area inside containment under-sink shutoffs are permitted. 3. The laboratory must be designed so that it can be easily cleaned and decontaminated. Carpets and rugs are not permitted. Seams, floors, walls, and ceiling surfaces should be sealed. Spaces around doors and ventilation openings should be capable of being sealed to facilitate space decontamination. Floors must be slip resistant, impervious to liquids, and resistant to chemicals. Consideration should be given to the installation of seamless, sealed, resilient or poured floors, with integral cove bases Walls should be constructed to produce a sealed smooth finish that can be easily cleaned and decontaminated Ceilings should be constructed, sealed, and finished in the same general manner as walls Decontamination of the entire laboratory should be considered when there has been gross contamination of the space, significant changes in laboratory usage, for major renovations, or maintenance shut downs. Selection of the appropriate materials and methods used to decontaminate the laboratory must be based on the risk assessment of the biological agents in use A. The BSL3 laboratory complex has gas-tight walls, ceilings and floors (i.e., capable of containing decontamination gas during the decontamination process); allow air gaps under and around doors for make-up air. High quality room construction with carefully silicone-sealed joints, seams, utility boxes, and other penetrations, penetrations limited to utilities within the room, and specially selected and professionally applied epoxy wall and ceiling coatings and finishes. Work surfaces, floors, walls and ceiling are designed, constructed, and finished to facilitate easy cleaning and decontamination, so that floors and ceilings are monolithic and walls and ceilings are finished with a dead smooth epoxy coating that is easy to clean and maintain. Omit unnecessary vertical and all horizontal surfaces that can collect contaminants (e.g., Unistrut, surface mounted conduit). B. All walls within and on the perimeter of a BSL3 suite mustshall reach the structural deck above regardless of ceiling height floating ceilings are not allowed. C. If the BSL3 suite must be located on an exterior wall due to programmatic, ceiling, or construction constraints, the suite will be constructed as a room within a room without load-bearing walls and including an air gap to preclude extremes of temperature to the walls. Fluctuations of temperature on the walls of the suite, not 10

11 internal to the building, can cause finish cracking and gaps can open in the wall finish, creating an uncontrollable leak path for decontaminant gases. D. No floor, wall, or ceiling penetrations that are not locally essential to the BSL3 laboratory operation are permitted within the containment envelope. E. All primary shutoffs will be external to containment. Secondary shutoffs may be provided inside containment but they mustshall be accessible without opening hatches or panels and their penetrations mustshall be sealed carefully with silicone. Access to fixed equipment requiring maintenance (autoclaves, HVAC components, lighting fixtures, video surveillance cameras) mustshall be completely outside containment. Plumb CO 2 and other specialty gases from outside of the containment envelope. Autoclave chamber drain piping is to be piped to discharge inside the BSL3 zone, not into the non-bsl3 side of the autoclave. Floors A. Easily cleaned, chemically resistant with a slip-resistant, smooth, hard finish, impermeable to liquids, monolithic/seamless.. Provide Sslightly roughened epoxy to prevent slippage is the preferred alternative. -- Sseamless high-strength vinyl is also allowed acceptable with Biological Safety Officer approval. B. Coved at least four (4) inches up the wall and caulked at the flooring-to-wall junction. Flooring will shall be installed and caulked before casework is installed so the floor extends underneath casework to provide good containment for spills. C. Ceramic tile and grout are not permitted anywhere in a BSL3 suite including the anterooms, shower stalls, restrooms, etc. Grout cannot be cleaned or decontaminated. Walls A. Design and construct the BSL3 with non-bearing walls, which are less likely to crack than are bearing walls. B. Provide Ssolid concrete or grouted concrete block walls are preferred (conduit and pipe locations mustshall be planned carefully so that these are installed prior to concrete pour or block grouting). These achieve a room within a room, but as noted above none may be a bearing wall and the wall to ceiling joint mustshall be gas-tight. Alternatively, hollow walls may be used if they reach the structural deck above and are fully sealed so that they are not contiguous with interstitial air space outside of containment. C. Hollow walls mustshall be durable (gypsum board), washable, and resistant to detergents and disinfectants. This could include impact resistant gypsum boards as well. Consult the University s Representative whether impact resistant gypsum board is required. D. Use durable glossy epoxy paint over a dead smooth epoxy surface coating that is compatible chemically and physically with the topcoats. E. Round exposed casework corners and provide carefully sealed wall bumpers in cart storage sites to protect corners and walls from damage by carts. 11

12 F. Wall and ceiling penetrations are limited only to those necessary for the immediate operation of the facility. Pass-through pipes, hatches, access panels, circuit panels, etc. are strictly forbidden anywhere in the BSL3 suite, including the anteroom complex. All penetrations are shall be sealed as noted under Plumbing above. G. Wall to wall, wall to flooring, wall to ceiling, and wall to casework corners will be caulked. Provide Ccarefully sealed, rounded corners and joints are optimum for easy cleaning. H. Locate penetrations as close to the site where needed as possible to minimize any need for external pipe or conduit runs. I. Utility boxes mustshall be constructed for wet applications and shall be fully recessed fully in hollow walls and sealed with silicone-sealed around the perimeter of the box between the box and the cut edge of the wall. J. Utility boxes are meticulously sealed with fluid silicone at all seams and conduit junctions inside the box and around the perimeter of the box between the cut edge of the wall and the box. Face gaskets and spray foam sealants are not acceptable methods to seal utility boxes. Manufacturer cut sheets shall be submitted for approval before boxes are released for shipment. Mockups of the proposed utility box sealing methods mustshall be reviewed and approved by the biological safety officer before use in the facility. K. Unistrut, and wiremold wiremold, or similar items shall not be used in a BSL3 laboratory, except where authorized by the Biological Safety Officer. When used, these fittings mustshall be caulked to the walls along the top and side junctions, and any seams within the wiremold mustshall also be caulked. Wall penetrations inside wiremold mustshall be minimized and sealed gas tight before the wiremold is closed. L. Exposed conduit or pipe runs are permitted only over block or concrete walls. Exposed conduit or pipe runs mustshall be vertical, caulked between the wall and conduit or pipe, and as short as possible. Ceiling A. Washable, resistant to detergents/disinfectants. B. Durable glossy epoxy paint compatible chemically and physically with a required smooth epoxy undercoating. C. MustShall be structurally compatible with the walls for maximum stability, and capable of being sealed gas tight permanently to the walls. D. Hard, monolithic construction. - Provide gypsum board or concrete, not removable tile is not acceptable. E. Access panels and hatches are not permitted within the BSL3 suite, including within the anterooms. F. A ceiling height of 10 feet is required. This provides the 12 inches of clearance above Class II Types A2 and B2 biological safety cabinets required by NSF/ANSI-49. However, ceilings mustshall not exceed 10 feet unless required for the project and unless the risk assessment allows. Cleaning ceilings higher than 10 feet is problematic. 12

13 Provisions for Room Decontamination A. Provide electrically operated bubble tight dampers on all exhaust duct runs between the room and the HEPA filter, to enable individual rooms to be isolated for decontamination. Dampers should be electrically operated to enable remote opening in an emergency (see E below). B. Provide two 1.5 inch stainless steel pipes ( VHP ports ) through the wall adjacent to the door of the individual BSL3 laboratories from the anteroom(s) to interface a standard vaporized hydrogen peroxide generator. The pipes should penetrate the wall within 15 inches of one another and be sited no more than five (5) feet above the floor. The pipes should extend no more than three (3) inches out from the wall inside and outside, and mustshall be NPT threaded and capped on each end C. Provide similar VHP piping in the wall between the first anteroom section and the remaining anteroom sections and, if where possible, between the first anteroom and the BSL3 laboratory. D. Seal all pipe penetrations to be airtight by means discussed above under Plumbing. E. Provide a wall switch outside of the BSL3 complex to enable rapid exhaust system startup including opening isolation dampers in case of a decontamination gas leak emergency. These typically have not been part of the laboratories that we have seen on Campus. Electrical A. Provide emergency power to exhaust fans, lighting, biological safety cabinets, incubators, and storage freezers at a minimum. Emergency power may be provided for other systems, consult the University s Representative. B. Provide uninterrupted power supply (UPS) power to alarms and to the biological safety cabinets. C. Provide UPS power to the control panels serving the BSL3 area. C.D. Independent circuit for each biological safety cabinet. D.E. The electrical system shall not reduce the air-tight integrity of the facility. Components will shall be sealed with silicone caulk. a. See notes above under Plumbing for penetration sealing instructions. b. See notes above under Walls for utility box sealing instructions E.F. Electrical boxes are shall be cast one-piece for wet applications or seams are sealed air tight with silicone caulk. F.G.Light fixtures are preferablyshall be accessible only solely from above (and outside of containment) for bulb-changing. Alternatively they may be surface-mounted or flush mounted if designed and sealed to the ceiling to maintain gas tight requirements. Bulbs are changed by biosafety staff in the case of surface mounted fixtures accessible from the room. G.H. Circuit breaker panels mustshall be located outside containment. 13

14 I. Label all circuit breakers and variable frequency drives as servicing a BSL3 laboratory, including HVAC breakers. BSL3 room outlets should be labeled with the correctly corresponding panel and breaker number. H.J. All Electrical panels/starters and Drives are to be identified as serving a BSL3 Laboratory with approved signage as approved by EH&S. 4. Laboratory furniture must be capable of supporting anticipated loads and uses. Spaces between benches, cabinets, and equipment must be accessible for cleaning. a. Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals. b. Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and decontaminated with appropriate disinfectant. Lab Furniture and Casework A. Minimize built-ins; consider moveable furniture with minimal wall and floor connections. B. Capable of supporting anticipated loads and uses. C. Spaced so that areas under benches, cabinets and equipment shall be accessible for cleaning; allow 6 room beneath for cleaning or cove floor up at least 4 at cabinets and benches. D. Bench tops are shall be impervious to water and resistant to acids, alkalis, organic solvents and moderate heat (epoxy resin). E. Sealed and caulked to the walls and floors on installation to facilitate cleaning and prevent vermin entry. F. Chairs and other furniture mustshall be covered with a non-fabric material that can be easily decontaminated. G. Tall cabinets/shelves are shall be permanently installed or seismically anchored. H. Cabinets/shelves shall have angled tops or are shall be built up to ceiling to facilitate cleaning. I. Joints at walls, floors, or elevation changes are shall be coved to facilitate cleaning. J. Sink cabinets mustshall be open in the back to provide free access to plumbing penetrations. K. Consider pprovideing open cabinetry (no doors) for the sink cabinets so that plumbing leaks will be easily detected, consult the University s Representative. L. All tall or heavy fixtures and equipment (e.g.: biological safety cabinets, autoclaves, etc.) should shall be fitted with a seismic anchoring system/device engineered to withstand earthquake stresses. 5. All windows in the laboratory must be sealed. 14

15 Windows AvoidWindows shall not be provided, except in doors between the dirty change room and the BSL3 laboratory.; Iif other windows are required, the following shall apply: A. Do not provide windows in exterior walls. B. Windows mustshall be installed gas-tight. C. Windows in doors or walls to permit view between rooms mustshall be safety glass, permanently closed and silicone sealed to be gas-tight. D. Slope interior sills (including door windows). 6. BSCs must be installed so that fluctuations of the room air supply and exhaust do not interfere with proper operations. BSCs should be located away from doors, heavily traveled laboratory areas, and other possible airflow disruptions. Biological Safety Cabinets A. Unless otherwise required, provide Class II Type A2 biological safety cabinets only. B. Provide canopy-connected (thimble) ducted exhaust for Class II Type A2 biological safety cabinets. C. Locate biological safety cabinets to the rear of the laboratory so that foot traffic does not pass in front of biological safety cabinets enroute to other laboratory equipment or work locations., D. Locate biological safety cabinets at least six feet from supply or exhaust registers. D.E. All biological safety cabinets will be certified according to NSF 49 standards. 7. Vacuum lines must be protected with HEPA filters, or their equivalent. Filters must be replaced as needed. Liquid disinfectant traps may be required. Vacuum Systems/Pumps A. House vacuum willshall not be provided to BSL3 suites. B. If vacuum is needed, small portable vacuum pumps will shall be used. Locate the pump in the BSL3 laboratory close to the work area. C. Vacuum lines are shall be HEPA filtered between the source and the pump 8. An eyewash station must be readily available in the laboratory. Eyewash/Safety Shower A. Emergency eyewash, plumbed to drain or installed over a sink, is shall be located in each BSL3 room. B. A combination emergency eyewash/safety shower unit shall be located close to sites where laboratory users are exposed to splash hazards. Alternatively, an eyewash 15

16 with a hand-held drench hose as a separate unit may be installed. Consult the University s Representative. Contact the campus Chemical Safety Officer for advice. C. Emergency eyewash and emergency eyewash/safety shower units will shall be sited and installed in accordance with Section D. Tempering valves are not required. 9. A ducted air ventilation system is required. This system must provide sustained directional airflow by drawing air into the laboratory from clean areas toward potentially contaminated areas. The laboratory shall be designed such that under failure conditions the airflow will not be reversed. a. Laboratory personnel must be able to verify directional air flow. A visual monitoring device which confirms directional air flow must be provided at the laboratory entry. Audible alarms should be considered to notify personnel of air flow disruption. b. The laboratory exhaust air must not re-circulate to any other area of the building. c. The laboratory building exhaust air should be dispersed away from occupied areas and from building air intake locations or the exhaust air must be HEPA filtered. A. Air flows unidirectionally from low hazard space into higher hazard space and is shall always be single-pass. B. Negative air pressure is shall be verified before entry. Install Provide a device(s) to indicate/confirm directional airflow into the suite (e.g inch Wg magnehelic gauges, digital differential pressure monitors, or both). C. Provide gauges at the door from the outside into the anteroom complex and at the last door in the anteroom complex into the BSL3 work area. D. Gauges mustshall be installed so that they can be viewed without opening the door a. Analog (dial) gauges may be installed above the entry door. b. Digital readout gauges shall be sited at eye level. c. Differential pressure devices mustshall be capable of communicating with the Energy Management System. b.d. Differential pressure alarms shall be sent to the Alarm Shop, consult the University s Representative. Heating, Ventilation, and Air Conditioning (HVAC) Systems A. No recirculation of eexhaust air shall not be recirculated. 100% -percent of the air shall exhaust to the outside. B. Dedicated Provide a dedicated exhaust system is required. C. An Provide an exhaust HEPA filter is required (see HEPA filter section). 16

17 D. Assure the BSL3 suite cannot become positively pressurized if the exhaust system fails. a. Supply gas-tight dampers b. Exhaust system redundancy E. An automatically operated gas-tight ( bubble-tight ) damper shall be provided in the supply ducting to isolate the supply system and prevent duct damage and puff-back in case of a supply failure. F. Supply side gas-tight dampers shall be pneumatically operated and capable of closing completely soon enough after exhaust failure to prevent even momentary positive pressurization in the affected rooms (<10 8 second delay between exhaust failure and full valve closure). G. To allow independent control of supply air and selective decontamination of individual rooms within the laboratory, a gas-tight damper should shall be provided for each supply duct within the containment envelope. H. Redundant exhaust fans mustshall be provided for room exhaust and for Class II Type B biological safety cabinets. I. Class II Type B2 biological safety cabinets exhaust mustshall be independent of room exhaust. J. Air supply and exhaust system capacity 125% percent of the BSL3 complex requirements. a. Each redundant exhaust fan mustshall be independently capable of handling 125% percent of the room or biological safety cabinet exhaust requirements. K. Negative air pressure may be provided by designing for 10% percent greater cfm of exhaust airflow than the supply air, or sufficient to maintain the differential pressure between rooms between inch Wg, as determined during design and commissioning phases. L. The air balance accommodates biological safety cabinets thimble exhaust or hard duct requirements. M. Provide stainless steel pneumatic tubing for supply air pneumatic dampers. (plastic Plastic tubing is vulnerable to rodentsnot acceptable). If this is not possible, precautions should be taken to protect the pneumatic tubing; consult the University s Representative. N. Locate air supply diffusers so that airflow at the biological safety cabinet face is unaffected (laminar diffusers at least six feet from the biological safety cabinet sash required). O. Ductwork in interstitial or support space is shall be exposed to stand clear of walls to allow for cleaning, maintenance, and leak testing. P. All exhaust ductwork upstream of the HEPA filter housing to be labeled with the universal biohazard sticker and with the notation that the exhaust comes from a BSL3 laboratory. Provide stenciled biohazard labels every three feet on all visible or accessible surfaces of the ductwork. Comment [CFV1]: Do you really want to go as negative as -0.20? Usually Cornerstone attempts to not exceed a magnitude of pressure beyond +/ (Note from others) 17

18 Q. Exhaust ductwork is shall be gas tight stainless steel with gas-tight welded joints, tested prior to installation and again when integrated into the exhaust system. R. Where possible, exhaust flow control devices (e.g., Phoenix valves or equal) placement to be downstream (clean side) of the HEPA filter housing. S. Fan coil units for supplemental cooling do shall not impact cleaning or breach biocontainment. T. Provide a comfortable temperature compensating for the heat load from equipment and for the personal protective equipment requirements for personnel in the lab. U. Provide a wall switch outside of the BSL3 complex to enable rapid exhaust startup including opening isolation dampers in case of a decontamination gas leak emergency (same wall switch as noted in the section on decontamination provisions above). 10. HEPA filtered exhaust air from a Class II BSC can be safely re-circulated into the laboratory environment if the cabinet is tested and certified at least annually and operated according to manufacturer s recommendations. BSCs can also be connected to the laboratory exhaust system by either a thimble (canopy) connection or a direct (hard) connection. Provisions to assure proper safety cabinet performance and air system operation must be verified. BSCs should be certified at least annually to assure correct performance. Class III BSCs must be directly (hard) connected up through the second exhaust HEPA filter of the cabinet. Supply air must be provided in such a manner that prevents positive pressurization of the cabinet Comment [CFV2]: Are we sure that we want this for the BSL3 areas? (from others) Formatted: Not Highlight A. Provide a Ssix (6) foot, canopy-connected Class II Type A2 biological safety cabinets preferred. B. Do not provide a Class III biosafety cabinet without the concurrence of the Biological Safety Officer, consult the University s Representative. 11. A method for decontaminating all laboratory wastes should be available in the facility, preferably within the laboratory (e.g., autoclave, chemical disinfection, incineration, or other validated decontamination method). Autoclave A. Pass-through to anteroom or support room outside of containment B. Provide vacuum exhaust autoclave rather than gravity displacement unit C. Body of autoclave located outside of containment to provide easy access for maintenance D. Autoclave has control panels at both doors; has dry and liquid cycles; is of sufficient size to handle waste coming from the lab. E. The autoclave controls are interlocked so that both doors cannot be open simultaneously. F. The outside door can only be opened if the autoclave has cycled successfully. 18

19 G. Use a bioseal or other equivalent means to create a seal at the containment wall. consult the University s Representative. H. Floor penetrations, if essential, shall have a water and gas-tight seal at the monolithic floor; if a risk assessment for the proposed laboratory use so indicates, the autoclave shall have an integral effluent decontamination system to handle the chamber discharge (verify with Biological Safety Officer). I. The floor under the autoclave shall be monolithic, seamless, coved to the wall, and water-tight. J. Walls and ceiling in the autoclave room will be monolithic, sealed dead smooth and covered with epoxy paint;. K. Provide sufficient space adjacent to interior and exterior autoclave doors for temporary waste collection. L. Insulate exposed pipes. M. A corrosion-resistant basin is shall be provided to prevent leakage. N. A stainless steel canopy hood is shall be provided over the outside door of the autoclave to contain heat and steam. N.O. Autoclave chamber drain piping is toshall be piped to discharge inside the BSL3 zone, not into the non-bsl3 side of the autoclave. O.P. The autoclave shall be seismically anchored. P.Q. The installation is signed offshall be inspected and approved by a professional engineer. 12. Equipment that may produce infectious aerosols must be contained in devices that exhaust air through HEPA filtration or other equivalent technology before being discharged into the laboratory. These HEPA filters should be tested and/or replaced at least annually. Comment [CFV3]: The bioseal design should be discussed by the design architect / engineer and the UC Davis Biological Safety Officer to ensure the design provides a quality seal. Site inspections and an architectural tightness. (from others) Comment [CFV4]: Is this the engineer of record, 3 rd party inspector, or Campus engineer? A. Provide HEPA-filtered centrifuges, incubators, and other equipment as specified in the designall specified equipment shall be HEPA-filtered. B. HEPA filters mustshall be certified after the equipment is installed and before the systems are commissioned as part of the integrated system testing, first use (and annually thereafter). 13. Facility design consideration should be given to means of decontaminating large pieces of equipment before removal from the laboratory. Equipment decontamination room A. Provide a room between building non-containment and the full containment area that is large enough to accommodate the largest single piece of equipment likely to be installed in the BSL3 laboratory. B. The decontamination room should include a lockable door between the room and the BSL3 laboratory and between the room and the non-containment space outside of 19