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WHAT IS A CLEAN ROOM?
Acleanroomisanextremelysophisticatedworkenvironment,designedandbuiltwiththeexpresspurposeofprovidingahighlevelofcleanlinessforaproductionorresearchfacility.Strictly controlled in terms of:
• Cleanroomclassification• Airparticles• Pressure• Airfiltration• Temperatureandhumidity• Entryofpeopleandparts
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Clean room classification TheUKstandardsareISO14644-1(2015)andEUGMP.Air particles Thecontrolofairborneparticlesiscriticaltothecontaminationcontrolwithinthecleanroom.Pressure Pressureispositivewithinthecleanroomandhigherthanthatofthesurroundingareas,controlledtocomplywithISO14644-1.Air filtration Airfiltrationiscriticaltothecleanroomasthisremovesparticlestoahighlevel.NormallyviaH.E.P.A.(HighEfficiencyParticulateAir)filters.Temperature and humidity Temperatureandhumidityiscontrolledforcomfortandforcriticalproductionrequirements.Entry of people and parts Theentrytocleanroomsisstrictlycontrolledtoauthorisedpersonneltrainedinthedisciplineofhygieneandgowningtechniques.Partsentryisalsocriticalsoasnottocontaminatethecleanroomenvironment.
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Why do we need clean rooms? Weneedcleanroomstoensuremedicinesandcriticalcomponentswhichcanbeputintohumans(oranimals)arenotcontaminatedatproduction/dispensingstage.WealsoneedcleanroomsintheMicroelectronicindustry,toensurenoparticulateispresentintheairwherecomplexMicroelectronicdevicesareassembled.Clean rooms can be found in many industries
• Pharmaceuticals,pharmacies(hospitals),celltherapy.• Medicaldevicemanufacturers,biotechnology.• Microbiology,aerospace,avionics.• Semi-conductorassembly,waferfabrication.• Microelectronics,opticaldevices.• Fibreoptics,plasticsmoulding.• Forensicscience.• Foodindustry,brewingindustry.• Paintspraying.• Cosmetic,plasticsurgery.
Thecleanroomfacilityoffersimprovedproductqualityandreliabilitywhenmanufacturedwithinaclassifiedcleanroom.
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Definition of clean air flow Airflowpatternswithinacleanroomare;
• Non-uni-directional–turbulentflow• Uni-directional–laminarflow•
Non-uni-directional(turbulentflow)Thisairisforcedintothecleanroomandflowsfreelyinaturbulentmannertoprovideeffectiveflushingofthecleanarea.Thisairflowremovesmicronizedparticlesthroughthedesignedre-circulatoryairsystem.Airentersatceilinglevelwithexhaustairleavingatlowlevel.Uni-directionallaminarflowThisairforcesallparticlestoflowinaregimentedpath.Theuni-directionalflowcanbeverticalorhorizontalandisnormallydirectlyfromaH.E.P.A.filterorflowscreen.Uni-directionalflowdevicescanbecabinets,modulesandevenafullcleanroom.
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Standard for UK ISO 14644-1 (2015) Maximumconcentrationlimits(particlesperm3ofair)forparticlesequaltoorgreaterthanconsideredsizesbelow(valuesuptothreesignificantfigures).ISO 14644-1 (2015)
Class 0.1 um 0.2 um 0.3 um 0.5 um 1 um 5.0 um
ISO1 10 d d d d e
ISO2 100 24 10b d d e
ISO3 1000 237 102 35b d e
ISO4 10000 2370 1020 352 83b e
ISO5 100000 23700 10200 3520 832 def
ISO6 1000000 237000 102000 35200 8320 293
ISO7 c c c 352000 83200 2930
ISO8 c c c 3520000 832000 29300
ISO9 c c c 35200000 8320000 293000
EU GMP ORANGE GUIDE
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PARTICLES Particulatecontaminationismeasuredbytheunitsmicrometreormicronandissignifiedasµandµgm1µgisthirtyninemillionthsofaninch.OrOnemillionthofametre.Thecontrolofparticulatecontaminationismeasuredinmicronsandingeneraliscompliantwithoneormoreofthestandardsclassification.
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Particle size example Ahumanhaironendmagnifiedtoa1000timeslargerNon-viableNon-livingparticles
100 microns
10 microns ViableLivingorganisms5 microns
• .5 microns
Mostparticulatecontaminationormostparticlepenetratingsizesarebetween0.3µmand0.5µm.Viable(living)organismswhicharemostlybacteriarangefrom0.5µmto5µmandareusuallyfoundincolony-formingunits.Virusesrangefrom0.003to0.05µm.
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Bacteria particle Smallerparticleswillgathertogethertoforma“raft”uponwhichbacteriamayprosper.Apercentageofthesebacteriawouldbepathogenic.Particulatebyitselfiscapableofproducinganembolism.Thisisanobviousdangertoacleanroomorasepticfacility,producinginjectableorparentaldrugs.Operator contamination Operatorcontaminationgeneratesmorethan50%ofparticleswithinacleanroom.Humancontaminationisofbothviableandnon-viableparticulatecontamination.
• 90%ofmicrobespectrumwithinthecleanroomiscomposedofstaphylococcimicrococciofhumanorigin.
• Anoperatoratrestshedsaround250,000particlesof>0.5micronperminuterisingbyafactorofthreeorfourwheninmotion.
• Bacteriacarryingcellsreleasedfromamaleoperatoraverageasmuchas5,000particlesperminute.
• Operatorsshedacompleteskinevery20workingdays.
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UN-GOWNED OPERATOR CONTAMINATION Operators shed
Particulate
SkinflakesEyelashesCosmeticsTobacco
Operators produce
Chemicalandorganicmatter
Sodium,magnesiumCalciumOraleffluviaIron
Operators generate
Biological
BacteriaVirusesPathogens
Operators outer clothing street generate
Highlevelsofparticulate
SiliconedustFibresCelluloseNylonWool
Cosmetics Lipsticksheds 1,000,000,000>0.5µmparticlesBlushersheds 1,600,000,000>0.5µmparticlesPowdersheds 1,300,000,000>0.5µmparticlesEyeshadowsheds 3,300,000,000>0.5µmparticles
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Controlling contamination Controllingcontaminationwithinacleanroomiscriticaltomaintainingitsclassificationandalsotoprotecttheproductorprocess,whichisbeingproduced.Bygowningandensuringoperatorsunderstandtheneedforentryprocedurescontaminationcanbecontrolled.Contaminationcanbebyparticulateorelectrostaticdischarge.Tocontrol/combatcontaminationtotheproduct/processadditionalminiclassifiedcleanenvironmentscanbeintroducedwithinthecleanroom.Oftentheseminiclassifiedenvironmentsareofahigherqualityairclassthanthegeneralroomenvironment.Example:Uni-directionallaminarflowcabinet.
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Clean room principles for entry Cleanroomoperatorsshouldfullyunderstandtheneedforacorrectentrydiscipline.Cleanroomoperatorsshouldbecleanandhealthy.Theyshouldnotentercleanroomswithouthavingagoodlevelofpersonalhygieneandshouldnotenteriffeelingunwell.
Personal hygiene
Medical health
Wash/bathefrequently
Beawareofallergies
Shampoohairfrequently
Beawareofrespiratorydisorders
Wearcleanundergarmentsdaily
Beawareofskinrashes
Wearcleanouterwearregularly
Beawareofspots
Avoidscratching
Beawareofdiseases
Shavedaily(male)
Beawareofmentalphobias
Keephairundercontrol
Donotenterifunsure
Strict No’s for a clean room operative
• Nocosmetics• Nojewellery• Noeatingofdrinking• Nopaper• Nohighheelshoes• Nouncleanpeople
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Clean room disciplines AllcleanroomsshouldhaveastrictEntry/ExitS.O.P.forallstafftoviewandcomplywith:In general:
• Wearcleanroomspecifiedclothing• Wearovershoes• Weargloves• Wearhaircover• Wearfacemasksasrequired• Wearglasses/gogglesasrequired• Usetackymats
Differentclassesofcleanroomsrequiredifferentlevelsofclothing;themorecriticaltheoperationorprocess,thehigherthelevelofclothingrequiredtocontaincontamination.Summary:
• Noeatingorsmokingorchewing• Wearprotectiveclothing• Keeptalktoaminimum• Nevercombhair• Neverapplycosmetics• Keeppocketsempty• Keeppaperout• EntryalwaysthroughChangeRoom• UnderstandS.O.P.forentry• WashhandsasperS.O.P.• Removeouterstreetclothing(ifrequired)• Ensuredoorsareclosedandnotwedgeopen• Donottakeanythingintothecleanroomthatisnotrequired• Smokersshouldrinsewithmouthwashbeforeentering• Entryofparts/toolsshouldbeunderastrictcleanpolicy• AirlocksshouldbesegregatedasInorOut• DonotExitviaAirlock,alwaysuseExitChange.
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Cleaning and maintenance Thecleaningofcleanroomsiscriticaltocontrolcontamination.ArigorousS.O.P.forcleaningshouldbeusedandallcleaningmaterialsvalidatedpriortouse.Maintenanceofcleanroomsshouldtakeintoconsiderationthecontaminationitmaygenerate,generalengineeringshutdownsrequirefullcleandownoncompletion.Validation testing TocomplywithISO14644-1(2015)andEUGMPClassrequirements,thecleanroomwillrequireindependentvalidationtestingtocomplywithISO14644-2andISO14644-3.Validationtestingisastatutoryrequirementforclassification.