15/12/2015

WhatisaCleanroom?CleanroomClassifications,Class1,10,100,1,000,10,000,100,000,ISOStandard14644,CleanroomDefinition

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WhatisaCleanroom?
CleanroomOverview|CleanroomAirFlowPrinciples|CleanroomClassifications|ISO146441CleanroomStandards
BS5295CleanroomStandards
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Typicallyusedinmanufacturingorscientificresearch,acleanroomisacontrolledenvironmentthathasalowlevelofpollutantssuchas
dust,airbornemicrobes,aerosolparticles,andchemicalvapors.Tobeexact,acleanroomhasacontrolledlevelofcontaminationthatis
specifiedbythenumberofparticlespercubicmeterataspecifiedparticlesize.Theambientairoutsideinatypicalcityenvironment
contains35,000,000particlespercubicmeter,0.5mmandlargerindiameter,correspondingtoanISO9cleanroomwhichisatthe
lowestlevelofcleanroomstandards.
CleanroomOverview
Cleanroomsareusedinpracticallyeveryindustrywheresmallparticlescanadverselyaffectthemanufacturingprocess.Theyvaryinsize
andcomplexity,andareusedextensivelyinindustriessuchassemiconductormanufacturing,pharmaceuticals,biotech,medicaldevice
andlifesciences,aswellascriticalprocessmanufacturingcommoninaerospace,optics,militaryandDepartmentofEnergy.
Acleanroomisanygivencontainedspacewhereprovisionsaremadetoreduceparticulatecontaminationandcontrolother
environmentalparameterssuchastemperature,humidityandpressure.ThekeycomponentistheHighEfficiencyParticulateAir(HEPA)
filterthatisusedtotrapparticlesthatare0.3micronandlargerinsize.AlloftheairdeliveredtoacleanroompassesthroughHEPAfilters,
andinsomecaseswherestringentcleanlinessperformanceisnecessary,UltraLowParticulateAir(ULPA)filtersareused.
Personnelselectedtoworkincleanroomsundergoextensivetrainingincontaminationcontroltheory.Theyenterandexitthecleanroom
throughairlocks,airshowersand/orgowningrooms,andtheymustwearspecialclothingdesignedtotrapcontaminantsthatare
naturallygeneratedbyskinandthebody.
^Backtotop
Dependingontheroomclassificationorfunction,personnelgowningmaybeaslimitedaslabcoatsandhairnets,orasextensiveasfully
envelopedinmultiplelayeredbunnysuitswithselfcontainedbreathingapparatus.
Cleanroomclothingisusedtopreventsubstancesfrombeingreleasedoffthewearersbodyandcontaminatingtheenvironment.The
cleanroomclothingitselfmustnotreleaseparticlesorfiberstopreventcontaminationoftheenvironmentbypersonnel.Thistypeof
personnelcontaminationcandegradeproductperformanceinthesemiconductorandpharmaceuticalindustriesanditcancausecross
infectionbetweenmedicalstaffandpatientsinthehealthcareindustryforexample.
Cleanroomgarmentsincludeboots,shoes,aprons,beardcovers,bouffantcaps,coveralls,facemasks,frocks/labcoats,gowns,glove
andfingercots,hairnets,hoods,sleevesandshoecovers.Thetypeofcleanroomgarmentsusedshouldreflectthecleanroomand
productspecifications.Lowlevelcleanroomsmayonlyrequirespecialshoeshavingcompletelysmoothsolesthatdonottrackindustor
dirt.However,shoebottomsmustnotcreateslippinghazardssincesafetyalwaystakesprecedence.Acleanroomsuitisusuallyrequired
forenteringacleanroom.Class10,000cleanroomsmayusesimplesmocks,headcovers,andbooties.ForClass10cleanrooms,careful
gownwearingprocedureswithazippedcoverall,boots,glovesandcompleterespiratorenclosurearerequired.
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CleanroomAirFlowPrinciples
CleanroomsmaintainparticulatefreeairthroughtheuseofeitherHEPAorULPAfiltersemployinglaminarorturbulentairflowprinciples.
Laminar,orunidirectional,airflowsystemsdirectfilteredairdownwardinaconstantstream.Laminarairflowsystemsaretypically
employedacross100%oftheceilingtomaintainconstant,unidirectionalflow.Laminarflowcriteriaisgenerallystatedinportablework
stations(LFhoods),andismandatedinISO1throughISO4classifiedcleanrooms.

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15/12/2015

WhatisaCleanroom?CleanroomClassifications,Class1,10,100,1,000,10,000,100,000,ISOStandard14644,CleanroomDefinition
Propercleanroomdesignencompassestheentireairdistributionsystem,includingprovisionsforadequate,downstreamairreturns.In
verticalflowrooms,thismeanstheuseoflowwallairreturnsaroundtheperimeterofthezone.Inhorizontalflowapplications,itrequires
theuseofairreturnsatthedownstreamboundaryoftheprocess.Theuseofceilingmountedairreturnsiscontradictorytoproper
cleanroomsystemdesign.
CleanroomClassifications
Cleanroomsareclassifiedbyhowcleantheairis.InFederalStandard209(AtoD)oftheUSA,thenumberofparticlesequaltoand
greaterthan0.5mmismeasuredinonecubicfootofair,andthiscountisusedtoclassifythecleanroom.Thismetricnomenclatureisalso
acceptedinthemostrecent209EversionoftheStandard.FederalStandard209Eisuseddomestically.ThenewerstandardisTC209
fromtheInternationalStandardsOrganization.Bothstandardsclassifyacleanroombythenumberofparticlesfoundinthelaboratory's
air.ThecleanroomclassificationstandardsFS209EandISO146441requirespecificparticlecountmeasurementsandcalculationsto
classifythecleanlinesslevelofacleanroomorcleanarea.IntheUK,BritishStandard5295isusedtoclassifycleanrooms.Thisstandard
isabouttobesupersededbyBSENISO146441.
Cleanroomsareclassifiedaccordingtothenumberandsizeofparticlespermittedpervolumeofair.Largenumberslike"class100"or
"class1000"refertoFED_STD209E,anddenotethenumberofparticlesofsize0.5mmorlargerpermittedpercubicfootofair.The
standardalsoallowsinterpolation,soitispossibletodescribee.g."class2000."
SmallnumbersrefertoISO146441standards,whichspecifythedecimallogarithmofthenumberofparticles0.1morlargerpermitted
percubicmetreofair.So,forexample,anISOclass5cleanroomhasatmost105=100,000particlesperm.
BothFS209EandISO146441assumeloglogrelationshipsbetweenparticlesizeandparticleconcentration.Forthatreason,thereis
nosuchthingaszeroparticleconcentration.Ordinaryroomairisapproximatelyclass1,000,000orISO9.
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ISO146441CleanroomStandards
maximumparticles/m3

Class

>=0.1m

>=0.2m

>=0.3m

>=0.5m

>=1m

FEDSTD209E
equivalent

>=5m

ISO1

10

ISO2

100

24

10

ISO3

1,000

237

102

35

Class1

ISO4

10,000

2,370

1,020

352

83

Class10

ISO5

100,000

23,700

10,200

3,520

832

29

Class100

ISO6

1,000,000

237,000

102,000

35,200

8,320

293

Class1,000

ISO7

352,000

83,200

2,930

Class10,000

ISO8

3,520,000

832,000

29,300

Class100,000

ISO9

35,200,000

8,320,000

293,000

RoomAir

BS5295CleanroomStandards
maximumparticles/m3

Class

>=0.5m

>=1m

>=5m

>=10m

>=25m

Class1

3,000

Class2

300,000

2,000

30

Class3

1,000,000

20,000

4,000

300

Class4

20,000

40,000

4,000

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