Biomedical Laboratory Deisgn Requirements

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Vol. 01 No. 03Vol. 01, No. 01April 2010‘Design Requirements Manual (DRM) News to Use’ is a monthly ORF publication featuring salient technical information that should be applied to the design of NIH biomedical research laboratoriesand animal facilities. NIH Project Officers, A/E’s and other consultants to the NIH, who develop intramural, extramural and American Recovery and Reinvestment Act (ARRA) projects will benefitfrom ‘News to Use’. Please address questions or comments to: ms252u@nih.govBiomedical Laboratory Design RequirementsAgeneral understanding of laboratory design isrequired for preparing the NIH Program ofRequirements (POR) and other planning andprogramming documents.Laboratories at the NIH are designed to a minimum ofBiosafety Level 2 (BSL-2). Biosafety levels above BSL-2meet minimum level 2 requirements plus additional safetyand security requirements as defined in separate chapters ofthe DRM. When designing an NIH Biomedical ResearchLaboratory, it is important to pay particular attention tosecurity, ventilation strategies, fume hood and biosafetycabinet (BSC) location, surface finishes and seam seals,lighting, noise, vibration stability particularly for the use ofspecialized equipment, traffic patterns, plumbing materials,etc. It is also important to include the users in the planningand programming of the facility.At a minimum, a NIH lab requires inclusion of a handwashing sink with an emergency eyewash; a safety showerwhere fume hoods are located or corrosives are handled; aUL rated flammable storage cabinet; an “INTERNALLYEXPLOSION SAFE” refrigerator, and a corrosive storagecabinet. All design features must be considered in relation tothe program and discussed with representative users.There are many types of laboratories at the NIH. Most labs,however are ‘wet labs’ where solutions or biologicalmaterials are used. Wet labs require bench space withkneeholes, work & hand washing sinks, chemical fumehoods and/or BSCs. A wet lab is fitted out with a full rangeof piped services such as deionized (DI) or reverse osmosis(RO) water, lab cold and hot water, lab waste/vents, carbondioxide (CO2), vacuum,compressed air, eyewash, safety showers, natural gas,telephone, local area network (LAN), lighting, power andaccommodation for medical pathologic waste (MPW).Development of a functional adjacency plan is importantwhen planning for associated lab spaces. Associated labspaces that are often overlooked but that are essential to thelabs operation include shared spaces such as instrumentrooms, wet and dry ice storage, and a restricted accessworkroom for radioactivity; the loadingdock, materials management, building operational areassuch as toilets, shipping and receiving areas, mechanical andelectrical rooms, telecommunications, utility distributionareas and provisions for controlled access as required by thespecific program.Utility capacity and redundancy must be considered.Three concepts should be addressed in the NIH lab designprocess. Lab space and utility services must be flexible sothey can be readily adapted to accommodate future changesin research protocols. The laboratory building must becapable of providing all the utility services necessary toconduct the research. Reserve capacity should be designedinto the primary building utility systems to allowresearchers to add equipment and instrumentation as needschange without compromising lab health and safety. Lastbut not least, state-of-the-art research buildings must bedesigned to accommodate expansion.Use of a modular design is critical for future flexibility. Thelaboratory module is the basic laboratory building block andshould offer predictability and reliability in the distributionof laboratory services. At the NIH, the lab module istypically 3 350 mm (11’-0”) wide and 10 056 mm long(33’-0”) with an aisle width of 1 525 mm (5’-0”) betweenthe bench or equipment space on each side of the aisle. Ageneral ‘rule of thumb’ for planning biomedical labs,assuming 2 persons per module, is that lab support space isbased on 50% of the laboratory space.The gross building area includes the total area of all floors,including basements, mezzanines, penthouses, mechanicaland electrical spaces, and enclosed loading docks. Grossarea is measured from the exterior surfaces of all enclosingwalls except where the exterior wall surface overhangs theexterior window surface by300 mm (1’-0’’) or more.For research labs, a grossing factor of 1.54 to 2.00 is typical.All utilities should be carefully organized into specificzones, both horizontally and vertically. The connectionpoint of each service should be in a uniform positionrelative to the module with simple extension into thelaboratory without disruption of adjacent modules.In planning a biomedical research laboratory, it is helpful touse resources such as the Room Data Matrix, Appendix C ofthe DRM. Information regarding Biosafety Level 3 andAnimal Biosafety Level 3 can be found in DRM Chapter 2Sections 5 & 6.Further details on this month’s topic are available on the DRM WEB r 2 Section 2-3, 2-5, 2-6: LaboratoriesFM

Vol. 01 No. 03Vol. 01, No. 02May 2010‘Design Requirements Manual (DRM) News to Use’ is a monthly ORF publication featuring salient technical information that should be applied to the design of NIH biomedical research laboratoriesand animal facilities. NIH Project Officers, A/E’s and other consultants to the NIH, who develop intramural, extramural and American Recovery and Reinvestment Act (ARRA) projects will benefitfrom ‘News to Use’. Please address questions or comments to: ms252u@nih.govAnimal Research Facility Design RequirementsMost of the same design principles that apply tobiomedical research laboratories also apply toanimal research facilities (ARF) (see April 2010).For example, the NIH ARF is designed to a minimum ofBiosafety Level 2 (BSL-2). Biosafety levels above BSL-2meet minimum level 2 requirements plus additional safetyand security requirements as defined in separate chapters ofthe DRM. Many additional features must be considered foran ARF. Minimum ARF requirements to meet AAALACcertification are outlined in the “Guide for the Care and Useof Laboratory Animals (Guide).” The NIH generallyexceeds AAALAC requirements. During planning, it iscrucial to identify the variety of species to be housed in thefacility over time; the temperature and humidity range thateach species can tolerate; and the degree of flexibility andadaptability required to accommodate different species.Vibration stability, noise damping, diurnal lighting, prepspace, surface finishes, sealing and caulking, andventilation, are other critical considerations in designing anARF. Since animal facilities present some of the mostchallenging pest management concerns, the NIH integratedpest management (IPM) program must be incorporated intothe design. The DRM provides guidance to create anergonomic and reduced allergen environment for facilityworkers. For example, an operating noise level of 85 dBashould not be exceeded in the cage wash area and changingstations are used to change the bedding to keep dust levelsas low as possible.At NIH, most of the animal holding rooms are designedfor small animals such as rodents or for non-humanprimates. The DRM contains guidance about other speciesthat are less frequently used at NIH but may requirespecialized facilities. Generally, any area where animals areheld for more than 24 hours is treated as holding area. Oftenan NIH ARF includes surgical and pathology areas,diagnostic equipment, multiple types of storage includingdrug and cold carcass storage.Natural light is not used in rodent housing areas wherethe research often requires regulated lighting cycles.Lighting should be on emergency power and monitored atthe room level independent from the method used to controlthe lights. Most small animals are stressed by noise so it isimportant to consider noise damping and acousticalisolation from animal holding rooms wherever possible.Animal holding room modular size is based on cagerack system size which may be different than a standardlaboratory module.The minimum recommended space between racks is 915mm. The ceiling height of the animal room and doors mustbe carefully planned for. The height is a function of themaximum rack height including rack fans. Adequate spaceabove the rack must be allowed for uniform airflowdistribution in the room.The ARF HVAC units are designed with N 1redundant system arrangements or with standby equipmentwith capability to ensure continuous operation duringequipment failure, power outages, and scheduledmaintenance outages. Although it is acceptable to have acommon air intake system for both animal holding and otherparts of the building, the animal area exhaust system mustbe independent of the non-animal exhaust systems of thebuilding. Utility connections to animal facility modulesinclude a small sink in each small animal holding room;selection of an animal watering system; placement ofweatherproof or waterproof protected electrical outlets withsufficient electrical loads to accommodate all the holdingand procedure room needs. Rack systems shall be connectedto the emergency power system. If a BSC or a laminar flowtransfer station is required, the impact of these systems mustbe considered in determining the room’s heat load and aircirculation patterns. Consideration must be given to specificpathogen free (SPF) zones, and clean and dirty areas whenplanning functional adjacencies.Cage wash rooms must be designed with a "dirty" sideand a "clean" side. The dirty side may require prep or descale pit. The DRM provides guidance for the pitspecifications. Dirty side equipment includes a bottlewasher, a cage and rack washer, tunnel type washers, acidneutralization tanks, and an autoclave. The autoclave shouldbe of sufficient size to contain full size or multiple cageracks and should be provided with “clean” steam to extendthe useable life of the equipment.The clean side isequipped with a large autoclave, bedding dispenser, animaldrinking water flush station, and water bottle filler. Linearspace for marshalling is also required on the clean side.An animal loading dock area shall be considered. TheDRM provides detailed guidance to ensure safe and secureanimal transfer into the facility.For further information, refer to the Room Data Matrix,Appendix C-Vivarium of the DRM; the IPM program inChapter 1 Section 1-11; animal biosafety level 3 (ABSL-3in Chapter 2 Sections 6 and Section 3-3-10-C: VivariumLoading Docks.Further details on this month’s topic are available on the DRM WEB r 2 Section 2-4: Animal Research FacilitiesFM

Vol. 01 No. 03Vol. 01, No. 03June 2010‘Design Requirements Manual (DRM) News to Use’ is a monthly ORF publication featuring salient technical information that should be applied to the design of NIH biomedical research laboratoriesand animal facilities. NIH Project Officers, A/E’s and other consultants to the NIH, who develop intramural, extramural and American Recovery and Reinvestment Act (ARRA) projects will benefitfrom ‘News to Use’. Please address questions or comments to: ms252u@nih.govPlacement of a Biological Safety Cabinet in the LaboratoryBiological Safety Cabinets (BSCs) are designed toprovide personnel, environmental and productprotection when appropriate practices andprocedures are followed. BSCs are typically used inresearch or pathology labs, animal facility procedure andhousing areas. Three kinds of BSCs, designated as Class I,II and III, have been developed to meet varying research andclinical needs. At NIH, BSCs are typically Class II. ClassIII BSCs may be installed in BSL-3/BSL-4 laboratories.Class I BSCs include HEPA filtration of theexhaust air leaving the cabinet. Class II BSCs includeinternal down airflow, which is HEPA filtered. This is inaddition to the separate HEPA filtration of the exhaust airleaving the cabinet. Class III BSCs consist of ventilatedglove boxes, which are gas-tight chambers. They includeHEPA filtration of the inward airflow and double HEPAfiltration of the exhaust air leaving the cabinet.Recognized standards for the design, fabricationand performance of BSCs include: NSF/ANSI 49-2009Class II (Laminar Flow) Biosafety Cabinetry by theNational Sanitation Foundation and the American NationalStandard Institute; and the CDC/NIH 2007 ”PrimaryContainment for Biohazards: Selection, Installation and Useof Biological Safety Cabinets” 3rd Edition. These standardsare intended to provide: personnel, product, andenvironmental protection; reliable operation; durability andstructural stability; ease of cleaning; limitations on erformance.When designing a room containing one or moreBSCs, consideration must be given to the location of eachBSC in relation to room heat loads and air circulationpatterns within the room.Appendix I of the DRM: Biosafety Cabinet (BSC)Placement Requirements for new Buildings andRenovations was added to the DRM in May 2010.Appendix I clearly defines specific minimum requirementsfor placement of a BSC through the use of “Do’s andDon’ts” diagrams. The design team should refer toAppendix I for the placement of every BSC.Performance of BSCs can be affected by thepresence of disruptive air flow patterns. Placement of BSCsshall avoid disruptive air flow patterns at the face of thecabinets. They shall be located out of the laboratorymainstream personnel traffic pattern or at the end of isles.In addition, they shall not be placed directly across from oneanother.A work zone around the BSC needs to beestablished. The work zone must include: a minimum of 40inches in front of the BSC; a minimum of 12 inches, oneither side, to adjacent walls or columns. In addition, clearspaces are needed around BSCs: a minimum of 80 inchesfrom opposing walls and/or 60 inches to opposing benchtops or areas of occasional traffic; and a minimum of 40inches are also needed between the BSC and bench topsalong a perpendicular wall. This clear floor space shall notoverlap with another BSC.In rooms with multiple BSCs, the use of staggeredarrangements is preferred. If this is not possible, there shallbe at least 120 inches between two BSCs facing each other.If two BSCs are placed next to each other, there shall be atleast 40 inches between them. BSCs along perpendicularwalls shall be placed 48 inches apart.It is not recommended that a BSC be placed nearan entryway. If the placement of a BSC near an entryway isunavoidable, the BSC face shall be placed, at least, 60inches from behind the doorway or 40 inches from anadjacent doorway.Air supply diffusers or exhaust vents shall not beplaced directly over or in front of BSCs, where airmovement can affect the airflow into the cabinet. In BSL-3laboratories, the placement of BSCs shall consider the totalroom ventilation rates. The design team shall be responsiblefor coordinating the exhaust air requirements for the BSCs.Lack of compliance with the criteria listed abovecan affect the ability of a BSC to maintain proper airflow toensure safety and proper containment of contaminants.Pressurized gases shall not be piped into BSCs.The use of compressed gasses (such as lab air) has beenshown to disturb intended airflow patterns within BSCs.The use of fuel gas has also proven hazardous, and isgenerally not required or desired in BSCs.BSL-3 laboratories, with Class III BSCs, shall beprovided with a dedicated exhaust air system. Thisdedicated exhaust air system shall not be used to serve therest of the laboratory space. Redundant exhaust fans andassessment of the location where the exhaust air isdischarged are very important to ensure there is no reentrainment back to outdoor air intake.Further details on this month’s topic are available on the DRM web ndGuidelines/DesignRequirementsManualPDF.htmDRM Chapter 4 Section 4-5-00 C.2; Section 4-7-10 A.1;Section 10-5 Chapter 6-1-00 D.5; Appendix I: Biosafety Cabinet Placement Requirements for new Buildings and Renovations; BMBL 5th ed.2007, CDC/NIH; the ACGIH, Industrial Ventilation, a manual of recommended practices. Chapter VIII.HVAC; Methodology for Optimization of Laboratory Hood Containment. Memarzadeh, F.National Institutes of Health, 1996; Microbiological Safety Cabinet Recommendations for Cabinet Installation, British Standards Institution, BS 5726:2005.FM

Vol. 01 No. 03Vol. 01, No. 04July 2010‘Design Requirements Manual (DRM) News to Use’ is a monthly ORF publication featuring salient technical information that should be applied to the design of NIH biomedical research laboratoriesand animal facilities. NIH Project Officers, A/E’s and other consultants to the NIH, who develop intramural, extramural and American Recovery and Reinvestment Act (ARRA) projects will benefitfrom ‘News to Use’. Please address questions or comments to: ms252u@nih.govFume Hood Requirements and TestingFume Hoods provide local exhaust ventilation tocontrol airborne hazards e.g. chemical fumes,flammable vapors and potentially dangerous dusts.Fume Hoods may be variable air volume (VAV) or constantair volume (CV) type. Although the use of VAV FumeHoods is highly recommended, the decision shall be basedon a comprehensive lifecycle cost analysis that accounts forall system features required by NIH.All Fume Hoods shall be manufactured under theANSI/ASHRAE STD 110 and shall meet minimumperformance ratings as described in DRM Chapter 6,Section 6-1-00 D.7.d. These performance criteria define theparameters for accurately validating the proper operation ofthe Fume Hoods. Fume Hoods to be used in NIH facilitiesshall meet specific criteria as detailed in the latest NIHDesign Requirements Manual (DRM). The criteria aredefined in NIH Specification Section 11810, NIHSpecification Section 11820, NIH Specification Section11830.All Fume Hoods installed in NIH facilities shall complywith the following NIH testing requirements: NIH Specification Section 15991-On Site TestingCV Fume HoodsNIH Specification Section.15992-On Site TestingVAV Fume HoodsAppendix E.3 “Fume Hoods Testing and AlarmSystem.”The NIH testing protocol, unlike ANSI/ASHRAE STD110, has clear pass and fail criteria whose target values mustmeet prescribed acceptance levels for dynamic and statictests. It assesses turbulent intensity (TI) which is morerepresentative of containment effectiveness than theparameters measured in the Standard ANSI/ASHRAE 110protocol. Contaminant leakage is observed from differentpositions within the hood, with a variety of sash openingsettings, at different face velocities and with movementacross the face of the hood with and without an operator. Itis important to perform a risk assessment, or in other words,to evaluate the Fume Hoods placement and workingconditions when establishing the face velocity. On-sitetesting and off site mock up to perform the NIH protocol isconducted independently of both the fume hoodmanufacturer and the fume hood control systemmanufacturer. Testing shall be conducted for at least 50% ofthe hoods provided in the project.All ARRA funded projects must comply with the NIHFume Hood manufacturing, testing and performancerequirements per the specifications listed in the DRM.VAV Fume Hoods in non-containment type labs shallhave no air-cleaning (HEPA or charcoal), except forradiological hoods.The laboratory in which a VAV Fume Hood is installedshall remain under negative pressure with respect to thecorridor or adjoining rooms even when the Fume Hoodoperates at the minimum exhaust air rate. When the exhaustair quantity is reduced, supply air quantity shall be redu

laboratory without disruption of adjacent modules. In planning a biomedical research laboratory, it is helpful to use resources such as the Room Data Matrix, Appendix C of the DRM. Information regarding Biosafety Level 3 and Animal Biosafety

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