Z8122:2000(1)121(JACA)(JSA)JISZ8122:1994JISZ8122:2000ContaminationControlTerminology1.1.2.JISB8241JISB9920JISB9921JISB9924JISB9925JISK3600JISK3800IIJISZ4812JISZ8103JISZ89013.a)1001b)2001c)1)30012)31013)32014)33015)3401d)2Z8122:20001)40012)41013)42014)43015)44014.1.2.3.a)1001physicalobject1002contamination1003contaminants1004contaminees1005contaminatedsource1006cleanness1007cleanliness1008environment1009carrier1010particlecontamination1011gaseous3Z8122:2000contamination1012Internalcontamination1013(surfacemicroroughness)1surfacecontamination1014filmcontamination1015particle,particulate1016particlesize101710µm100µm2µmcoarseparticle10181µm2µmfineparticle10190.11µmsubmicronparticle10201100nmnmultrafineparticle1021JISK3600aerosol10221.2.dust102310fibreparticle1024SPMairborneparticleliquidborneparticlesuspendedparticulate4Z8122:2000matter1025ionparticle1026mist1027fume1028particulatecontaminant1029CO2SO2NOx(1)NH3(1)NOxAMCgaseouscontaminantairbornemolecularcontaminant(acid,base,condensable,dopant)1030concentratioofcontaminant1031concentratioofairbornecontaminant1032particleconcentration1033mg/m3ppmgasconcentration1034JISZ8103massconcentration1035equivalentconcentration1036equivalentmassconcentration,concentration1037JISZ8103numberconcentration1038opticaldensity,opticalconcentration1039concentratioofsurfacecontamination1040dilution5Z8122:2000104111geometrisize1042equivalentdiameter1043particlesizedistribution1044angleofcontactcontactangle1045filtration1046sedimentation1047coagulation104821impact,collision1049dispersion1050diffusion1051adsorption1052absorption1053sorption6Z8122:20001054,condensation1055precipitation1056chemicalhazard1057aircleaning1058non-shedding1059lintfree1060highlypurifiedair1061insolublesolidparticulate1062concentratioofliquidbornecontaminant1063µs/cmms/cmconductivity1064MΩcmat2518.25MΩcmresistivity1065outgassing1066BODbiochemicaloxygendemand7Z8122:2000205mg/lppm1067106110TDStotaldissolvedsolid10680.21µmnon-volatileresidue1069DIwater,purewater,deionizedwater1070518MΩcmprimarypurewater,primarydeionizedwater1071(TOC)101(µg/l)DIpurewaterultrapurewater10722ionexchangeresin1073regeneration8Z8122:20001074ROreverseosmosismembrane,(RO)1075UFultrafiltrationmembrane,(UF)1076µm100µmMFmicrofiltrationmembrane,(MF)10776000hyperfiltration1078viableparticle1079bioaerosolairbornemicrobeliquidbornemicrobe1080settlingmicrobe1081biocontamination,microbialcontamination,microorganismcontamination1082crosscontamination1083(cross-infection)(self-infection)nosocomialinfection,hospitalinfection1084opportunisticinfection9Z8122:20001085toxoid1086pyrogen10871100(A.flavus)(A.paraciticus)15aflatoxin1088exotoxin1089endotoxin1090resistantbacteria10912DNADNAplasmid1092D90%101Dvaluedecimalreductiontime1093F10Z1D121.1(250F)FF(FF-physical)FvalueFbiologicalvalue1094ZD1ZZvalue10Z8122:20001095UF90%95%molecularcutoff1096purifiedwater1097distilledwater1098sterilepurifiedwater1099waterforinjection110044.12.21691000ml04815sterilizedwaterforhand-scrubbing11011110µmbacteria11021fungi1103sterilization1104sterilization1105disinfection1106DNAcontainment11Z8122:20001107pathogen1108SPFconventionalanimal1109SPFspecificpathogenfreeanimal1110conventionalanimal1111germfreeanimal1112gnotobioteanimal1113DNAbiohazard1114tissueculture1115DNAenvironmentalrelease1116survivingorganismcount1117initialorganismcount1118BacillusstearothermophilusBacillussubtilisindicatororganismsforsterilization1119viablecellcount,countingbacteria-cell1120reductionrateb)2001contaminationcontrol12Z8122:20002002environmentalcontrol2003controlledarea,barrieredarea2004particlecontrolledarea2005cleanworkarea2006aircleaningload,contaminationload2007unidirectionalairflow2008non-unidirectionalairflow2009a)b)c)3cleanroomoperationalphase1.asbuilt2.atrest3.operational2010cleanlinesslevel2011JISB99201m30.1µm1018cleanlinessclass2012cleanlinesscontrollevel2013cleanroompersonnel2014gowning,clothingchange(gowningsystem)2015airflowvelocity13Z8122:20002016airflowuniformity2017airflowparallelism2018roompressure2019cleanlinessrecoverycharacteristic2020inductionleakage2021HEPAULPAleakagetest2022HEPAULPAscanningleakagetest2023HEPAULPApartialscanningleakagetest2024HEPAULPADOPin-placefiltertest20251.cleanroomcleanlinesstestmethod14Z8122:20002.20260.220.45µmmembranefiltermethod2027MPNmostprobablenumbermethod(MPNmethod)2028normalaircleanlinessevaluationmethod2029JISB9920sequentialsamplingaircleanlinessevaluationmethod2030ratedquantityofflow2031facevelocity2032LVlinearvelocity2033SVspacevelocity2034STspacetime2035pressureloss2036C1C2121CCC−=ηη100%particlecollectionefficiency,particleremovalefficiency15Z8122:20002037partialparticlecollectionefficiency,ractionalefficiency2038PηP(1η)penetrationefficiency2039maximumpenetratingparticlediameter2040dustholdingcapacity2041C1C2121CCC−=ηη100%gasremovalefficiency20421gasremovingcapacity2043cleaning2044mechanicalcleaning2045physicalcleaning2046flamecleaning2047wetcleaning2048preliminarywashing2049precisioncleaning2050dipwashing,soakcleaning2051chemicalcleaning2052