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FacilitiesandEnvironmentalConditions
(linkedtoVol.III,sec.2)ORALAB.5.3
ORALaboratoryProcedure
FoodandDrugAdministration
DOCUMENTNO.:
ORALAB.5.3
VERSIONNO.:1.3
FacilitiesandEnvironmentalConditions(linkedtoVol.III,sec.2)ORALAB.5.3
EFFECTIVEDATE:
10/01/2003
REVISED:
07/29/2008

SectionsIncludedinthisDocument/(ChangeHistory)
1.Purpose
2.Scope
3.Responsibilities
4.Background
5.References/(Deleteddatesfromreferences1,5.and6)
6.Procedure
7.Definitions
8.Records
9.SupportingDocuments
10.Attachments
11.DocumentHistory

1.Purpose
ThisdocumentdescribestheguidelinesforFoodandDrugAdministration/OfficeofRegulatoryAffairs(FDA/ORA)
laboratoryfacilitiestoensurethattheenvironmentalconditionsdonotadverselyaffectorinvalidatesamplehandling,
instrumentation,analyticaltesting,andcalibrations.

2.Scope
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2.Scope
ThisprocedureappliestoallORAchemistryandmicrobiologylaboratoriesincludingradionuclideandmedicaldevice
testinglaboratories.

3.Responsibilities
1.TheORAlaboratoryDirectorsareresponsibleforensuringthefollowingconditions:
laboratoryfacilitiesmeettherequiredenvironmentalconditions,includinganyneededseparationofwork
areastoensurethatanalysesandcalibrationswillnotbeadverselyaffectedwithinresourcesprovided
laboratorystorageareasprovideproperstorageofsamples,reagents,microbiologicalmedia,chemicals,
selectagents,standardsandreferencematerials,andradioactivewastesandhazardouswaste
anyadditionallaboratoryconditionsneededforspecializedanalysesaremet,includingstructural,equipment
needsandproceduresforthehandlingandanalysisofextremelyhazardousbiologicalandchemicalmaterial
withinresourcesprovided
additionalresourcesneededareidentifiedandfacilitateprocurement
scheduledcleaningandmaintenanceserviceofthelaboratoryfacility
apestcontrolprogramisinplaceand
modificationstothelaboratorytoaccommodatenewequipment,soitdoesnotinterferewiththeenvironmental
controlsinthelaboratory.
2.TheSupervisorsareresponsibleforthefollowing:
implementingenvironmentalcontrolprogramsinthelaboratory,
continuallaboratorysurveillancetoensureproperconditionsarebeingmet,and
recognizingwhenenvironmentalconditionsarenotmetandadverselyaffecttestsorcalibrationsbeing
performed.
3.Alllaboratoryemployeesareresponsiblefor:
planningandconductinglaboratoryoperationsindesignatedareas
monitoringanddocumentingenvironmentalconditionsintheirareas
identifyingandimplementinganyenvironmentalcontrolsneededtocompletesampling,analysisand
calibration,andensurethesefactorsdonotadverselyaffectthequalityofthework
goodhousekeepingpracticesand
properhandlingandstorageofhazardouswaste,asdefinedintheHazardousWastePlan,soasnotto
adverselyeffectlaboratoryoperations.

4.Background
None.

5.References
CenterforDiseaseControl,NationalInstitutesofHealth.Biosafetyinmicrobiologicalandbiomedical
laboratories,currentedition.Washington,DC:UnitedStatesDepartmentofHealthandHumanServices,Public
HealthService.

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CRCHandbookofLaboratorySafety.
CodeofFederalRegulations.Title29,Part1910.1450.WashingtonDC:GovernmentPrintingOffice.
CodeofFederalRegulations.Title29,Part1910.1000.WashingtonDC:GovernmentPrintingOffice.
AmericanNationalStandardsInstitute/AmericanIndustrialHygieneAssociation(ANSI/AIHA)Z9.5Standard
LaboratoryVentilationGuidelines
NationalScienceFoundation(NSF)ANSI49ClassII(LaminarFlow)BiosafetyCabinetry

6.Procedure
6.1Environment
Thelaboratoriesaredesignedtoprovidespace,engineeringcontrols,andproperenvironmentalconditionsforoptimal
samplestorage,samplehandling,analysis,andcalibrations,inaccordancewithgenerallaboratorypractices,safety,
andapplicableFederal,Stateandlocalregulations.
6.1.1Facilitiesconsistoflaboratories,officeareas,storagerooms,andspecialpurposeareas.Laboratoriesare
sectionedbytestingcompatibilityanddesigncapabilities.Floorsinthelaboratoriesareconstructedfromamaterial
thatisresistanttomostchemicalspillsandeasilydisinfected.Microbiologylabsaredesignedtominimizeareaswith
cracksorfibersthatcouldservetoaccumulatedebrisandserveasanareaforgrowthofmicroorganisms.Floorsare
clean,dry,andinsoundconditionsotherearenotrippinghazards.
6.1.2Laboratoriesareequippedwithclimateandventilationcontrol.Thetemperatureandhumiditywithinthe
laboratoryaremaintainedwithinlimitsfortheproperperformanceofeachtestoranalysisandmaintainedaccording
tothemanufacturersspecificationsfortheproperoperationofinstruments.Acomfortableworkingenvironmentis
considered20to25Cwithrelativehumidityof35to50%dependingongeographicalarea.Ingeneral,thework
areasshouldbefreeoftemperatureextremesthatarehazardoustohealthorwhichinterferewithsafeoperations.
Laboratorieswheretoxicmaterialsarehandledareundernegativepressuretoadjoiningareaswith8to12air
changesperhour.Highhazardlaboratories,animalfacilities,andBiosafetyLevelIIIsuiteshaveuniqueworking
conditions.Work,storageareas,andrestroomsarefreeofnoxiousodors.Exhaustventilationismaintainedfor24
hoursperdayinanyareawherechemicalsarestoredorused.Nolaboratoryairisrecycledthroughthebuilding.The
supplyventsshouldnotexceed50feetperminute(FPM)airflow.
6.1.3Thelaboratorymaintainsilluminationsufficientfortheprocedurebeingperformedandthenoiselevelsconform
withinOccupationalHealthandSafetyAdministration(OSHA)guidelines.Lightingisatsuggestedlevelof80to100
footcandleintensityunlessitaffectstheanalysisandotherlightingisneeded.Specializedlightingmaybeneededin
areaswheredirectsunlightcanbedeleterioustosamples,reagentsandmediaorcaninterferewithinstrumentation
oranalysis.
6.1.4Workbenchspaceissufficienttoperformoperationsandtopreventclutter.Benchesareconstructedofa
materialthatiseasilydisinfectedandimpervioustomostchemicalspills.Benchspaceisconvenienttosinks,water,
gas,suction,andelectricaloutletsneededtoproperlycarryouttestsoranalysesofferedbythelaboratory.
6.1.5Thelaboratoriesareequippedwithchemicalhoodstocapturehazardousorodorousmaterialsusedor
producedintheanalysesandtoprotectemployeesfromhazardousconcentrationsofairbornetoxicsubstances.
ClassIIbiosafetycabinets(BSC)areprovidedforbiohazardousanalysisandsterilitywork.Laminarflowcabinetsare
disallowedbecauseofthelackofemployeeprotection.Sufficienthoodspaceshouldbeprovidedlaboratory

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employees.Facevelocitiesforchemicalhoodsshouldbewithin80to120FPMwithminimaldistortionofair
movement(crossdrafts)throughthefaceofthehoodfromactivitiesorsourcesintheroom.Maintenanceisperformed
routinelyonthesesystems.
6.1.6Localutilitiescompaniesprovideelectricityandwater.Anauxiliarypowergeneratingsystemisinplaceto
provideemergencypowerforhazardousorsensitiveoperations.Recommendedparametersforelectricalpower
includevoltageregulationtowithin5to10%ofnominalwithminimumlinetransientsandagroundingsystem.Voltage
regulationisimportantforinstrumentationtomaintainstable,driftfreeoperation.Constantvoltagetransformersarein
placetoregulatevoltagewherelinefluctuationsoccur.Allinstrumentsandequipmentaregrounded.TypeIorTypeII
waterisfordilutions,preparationofreagentsolutionsandfinalrinsingofglassware.Groundfaultinterruptersare
usedinwetareaswherethereisashockhazard.Electricalserviceissuppliedandcircuitbreakersareidentifiedin
electricalboxes.
6.1.7Separatestorageareasofsufficientsizearepresentinthelaboratorytoensurethatglassware,portable
instrumentation,microbiologicalmedia,supplies,reagents,solvents,chemicals,hazardousorregulatedwastesand
referencestandardsandmaterialsareproperlystored.Separatestorageareaspreventcontaminationordegradation,
ensuresthelaboratoryisincompliancewithregulatoryauthorities,meetssecurityneeds,assurespersonnelsafety,
andminimizesclutter.Chemicalsandsolventsarestoredcompatiblyandinaccordancewiththemanufacturers
guidanceintheMaterialSafetyDataSheet(MSDS)andthefirecode.Storageareasforsamplesareto
accommodateretentionofsamplesforthetimesandconditionsneededtoprotecttheirintegrity.Shelvingunitsin
storageareasarebracedtopreventcollapsingoftheshelves.
6.2Monitoring
6.2EnvironmentalMonitoring
NOTE:Calibrationsoranalysisofsamplesarenotperformedifmonitoringrevealsthatrequiredenvironmental
conditionsarenotmet.
6.2.1Inlaboratoryroomswheretemperatureandrelativehumidityaffecttheanalyticalresults,temperatureand
humidityaremonitoredandrecorded.Insomeinstances,thetestisplacedinasmallercontrolledenvironmentsuch
asanincubator.
6.2.2ChemicalhoodsandBSCarevisuallycheckedforproperoperationbeforeeachuse.BSCsandchemicalhoods
arecertifiedannually.Asaminimum,airflowvelocitiesinhoodsaremeasuredforthefollowingtwosituations:(a)
Hoodsaremeasuredannually,beforeusewithaverytoxic,lowpermissibleexposurelimit(PEL)ortimeweighted
average(TWA)valuematerial,and(b)wheneverthereisafluctuationinperformance.Biosafetycabinetsare
additionallymonitoredforparticulateswheneverthereisaconcern.AmagnehelicgaugeontheBSCmonitorsthe
staticpressureonthehighefficiencyparticulateHEPAfiltertodeterminewhenthefilterneedschanging.
6.2.3Benchsurfacesandhoodsinmicrobiologylaboratoriesaremonitoredformicrobiologicalcontamination
periodically.Additionally,airsamplingisperformedperiodicallytomonitorformicrobiologicalcontaminationinthese
laboratories.Routinely,aseriesofantimicrobialcleansersareusedinthemicrobiologylaboratoryattheendofan
analysis,attheendoftheday,orintheeventofaspilltominimizeanypotentialmicrobialcontamination.Inthe
chemicallaboratories,airmonitoringisconductedwheneverthereisacomplaintofodorsorothersuspectindications
ofthepresenceofachemical.MonitoringismandatorywhenthechemicalisregulatedbyOccupationalSafetyand
HealthAdministration(OSHA)asatoxicaircontaminantin29CFR,Part1910.1000andthereisreasonable
evidenceofemployeeexposure.
6.2.4Distilledordeionizedwatersystemsaremonitoredforconductivity,bacterialcontent,andtotalchlorine
periodically.Heavymetalsanalysis,waterqualitytestandusetestareperformedannuallyonthewatersystems.

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6.2.5Inlaboratoriesthatperformmetalanalysis,benches,hoodsandglasswarearemonitoredperiodicallyformetal
contamination.
6.2.6Routineinsertionofanalyticalandmediablankswithsampleanalysisdetectslaboratoryenvironmental
contaminationandanycrosscontamination.
6.3Segregation
Separateareasaremaintainedforincompatibleactivities,andmeasuresaretakentopreventcrosscontamination.
Forexample,noorganicsareusedinaperchloricacidhood.
6.3.1Samplereceivingandstorageisconductedindesignatedareaswhichareseparatefromthemainpartofthe
laboratory.
6.3.2Thelaboratoryareasareseparatedfromothersectionsinthebuilding,suchasAdministrativeServices,
InvestigationBranch,ComplianceBranch,lunchroomandconferenceroomfacilities.
6.3.3Areasofspecializedtestingareseparatedfromgeneralworkareas.
6.3.4Chemical,standardsandreferencematerialsandculturesarestoredseparatelyfromsamples.
6.3.5Microbiologymediapreparationandsterilizationareasareseparatedfromworkareastopreventcontamination
ofcleanmedia.
6.3.6Wherefeasible,volatileorganicoperationswillbephysicallyseparatedfromsolventandsamplehandlingareas
andvented.
6.4Housekeeping
Laboratoryareasaremaintainedsufficientlycleanandorderlytopreventcontaminationofsamplesandtofacilitate
theefficiencyoflaboratoryoperations.
6.4.1Housekeeping,asaminimum,includesthefollowingactivities:
sweepingormoppingfloors,includingwalkinrefrigerators
cleaningupspillsimmediately
adequatelydecontaminatingandcleansingglassware
cleaningcontaminatedequipment,removingallchemicalsuponcompletionofanalysis,removingallcontaminants
whentheequipmentisplacedinsurplus
disposingofradioactive,infectious,DEAcontrolled,selectagent,hazardous,anduniversalwastesproperly
controllingpests
emptyingtrashcans
vacuumingcarpet
cleaningrestroomsand
monitoringstorageareastoensurestorageconditionsarecleananddry,thereisnoleakageofproduct,timely
dispositionofmaterials,andpropercontainmentoffensivematerials.
NOTE:Contractorsperformaportionofthehousekeepingresponsibilitiesunderthedirectionoftheimmediate
supervisorortheprincipalanalyst.Contractorsarenotallowedincertainlaboratorieswithoutescortandguidance.

7.Definitions
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7.Definitions
AccommodationThisreferstospaceinthelaboratoryareaandhowitissuitedfortheworkperformed.
ExtremelyhazardousThisisacharacteristicofchemicalcompoundsthatarehighlytoxicordangerous,suchas
arsenicorradioactivematerials.
ClutterThisreferstoacrowded,confused,messorcollectionofthings.
IncompatibleActivitiesoranalyseswhichinterfereoradverselyaffectotheractivitiesoranalysisinthesameareaare
consideredincompatible.

8.Records
Temperatureandhumidityrecords
Maintenance,certificationandperformancerecordsonchemicalhoodsandbiosafetycabinets
Surfaceandairsamplingrecordsformicrobiologicalcontamination
Maintenanceandperformancerecordsonwatersystems

9.SupportingDocuments
None.

10.Attachments
None.

11.DocumentHistory
Name&Title
Version
No.

Status
(I,R,C)

Date
Approved

LocationofChangeHistory

Author

ApprovingOfficial

1.1

1.2

100103

LMEB

LMEB

1.3

08/15/08

InDocument

LMEB

LMEB

ApprovingOfficialssignature:
_________________________________Date:_____________

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