APPLICATION NOTEPO Box 531, Cambridge, NZ Telephone + 64 7 827 4142

Cleanroom Standards and ClassificationsCleanroom technology has developed into a specialist field with its own technical journals, its own conferences and exhibitions, and its own language of technical terms and classifications. This application note covers relevant standards and attempts to clarify the myriad classification systems. Cleanroom Standards

Facsimile + 64 7 827 8435 www.aircaretechnology.co.nz Ph 0800 774 100 Fax 0800 774 101

The main cleanroom standards of interest in New Zealand are as follows: AS 1386:1989 This standard in seven parts has been widely used in New Zealand as a reference for design, operation and validation of cleanrooms. FED-STD-209E:1992 Until recently, this standard was used throughout the US and by auditors from the US. It was cancelled in November 2001 in favour of ISO 14644, but its classification system will undoubtedly be used for years to come. ISO 14644 Cleanrooms and associated controlled environments (8 parts) ISO 14698 Biocontamination control (3 parts) These 11 documents will make up a set of global cleanroom standards. They are still being developed, with some already released and most of the others available in draft form. RefISO 14644-1 ISO 14644-2 ISO 14644-3 ISO 14644-4 ISO 14644-5 ISO 14644-6 ISO 14644-7 ISO 14644-8 ISO 14698-1 ISO 14698-2 ISO 14698-3

TitleClassification of Air Cleanliness Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 Metrology and test methods Design, construction and start-up Operations Vocabulary Separative devices (clean air hoods, glove boxes, isolators, mini-environments) Classification of airborne molecular contamination General principles Evaluation and interpretation of biocontamination data Measurement of the efficiency of cleaning processes

StatusReleased May 1999 Released Apr 2000 Draft under discussion Released Apr 2001 Draft Available Draft Available

Draft Available Draft Available Draft Available

May 2003

Air Care Technology Ltd

Cleanroom Classifications Cleanrooms are classified according to the concentration of airborne particles. The following table shows the ISO 14644-1 classification for the main particle sizes of interest together with comparable AS1386 and FED-STD-209E classifications. ISO Class1 2 3 4 5 6 7 8 9

Max concentration (particles/m3 of air) for particles equal to or greater than size shown 0.1m 0.3m 0.5m 5m10 100 1000 10000 100000 1000000 10 102 1020 10200 102000 4 35 352 3520 35200 352000 3520000 35200000

FED-STD-209E Class

AS1386 Class

29 293 2930 29300 293000

1 10 100 1000 10000 100000

0.035 0.35 3.5 35 350 3500

ISO classes 1-4 are mainly applicable to the semi-conductor industry and we are not aware of any such cleanrooms in New Zealand. Classes 5, 7 and 8 are most common. The airborne particle concentration in a cleanroom is highly dependent on the occupancy of the room because occupants are major particle sources. So the classification of the cleanroom must be defined at one or more of the rooms occupancy states, viz. as-built, at rest, or operational. For example, a cleanroom may be class 7 (= class 10000 = class 350) in the operational state and class 5 (= class 100 = class 3.5) in the at rest state. Good Manufacturing Practice (GMP) There are two methods by which cleanrooms and semi-clean rooms have been specified in New Zealand. For the Food Industry, MAF have traditionally specified the air filters required. For example air filtration of EU5 or better for processing areas is specified in the Meat Industry Agreed Standard 2 Design and Construction (1). This may be appropriate for low-level clean spaces, but is not ideal. The filtration efficiency is only one factor determining the cleanliness of the space the airflow, the room construction, the room pressurisation and the operations in the room are also important factors. Furthermore, unless the air filters are well manufactured and properly installed, a significant proportion of air can bypass the installed filters. The other method is to specify the air quality using a cleanroom classification system as described above. The Australian Therapeutic Goods Association use the AS1386 classification. For example, in the code of GMP for medicinal products (2), the general requirement is Class 7000 which is extrapolated from AS1386. This requirement is commonly used in New Zealand for food processing areas. Also commonly used in New Zealand is the UK (European) Orange Guide (3) which defines 4 grades of cleanrooms for manufacture of sterile medicinal products according to air quality in both the at rest and in operation states.

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Air Care Technology Ltd

Orange Guide GradeA B C D

At rest In operation 3 Max permitted particles /m equal to or larger than 0.5m 5m 0.5m 5m3 500 3 500 350 000 3 500 000 0 0 2 000 20 000 3 500 0 350 000 2 000 3 500 000 20 000 Not defined

Max permitted viable microorganisms /m3=0.2m >=0.3m >=0.5m >=5.0m 7.5 3 1 NA 75 30 10 NA 750 300 100 NA NA NA 1.000 7 NA NA 10.000 70 NA NA 100.000 7003

>=0.1m 35 350 NA NA NA NA

LmitesdelasClasesdelFederalStandard209E LimitesdelaClase >=0.2m >=0.3m VolumeUnits pi3

N ombredelaClase SI English M 1 M 1.51 M 2 M 2.510 M 3 M 3.5100 M 4 M 4.51.000 M 5 M 5.510.000 M 6 M 6.5100000 M 7 m3

>=0.1m m 9.91 35 99.1 350 991

>=0,5m3 3

>=5.0m3

3

pi

3

m

3

350 1.240 3.500 12.400 35.000

75.7 265 757 2.650 7.570 26.500 75.700

2.14 7.50 21.4 75.0 214 750 2140

30.9 106 309 1.060 3.090 10.600 30.900

pi m 0.875 10.0 3.00 35.3 8.75 100 30.0 353 87.5 1.000 300 3.530 875 10.000 35.300 100.000 353.000 1.000.000 3.350.000 10.000.000

pi 0.283 1.00 2.83 10.0 28.3 100 283 1.000 2.830 10.000 28.300 100.000 283.000

m

3

247 618 2.470 6.180 24.700 61.800

LmitesdelasClasesdelEstndarI SO146441 N merodela ClasificacinI SO ISOClase1 ISOClase2 ISOClase3 ISOClase4 ISOClase5 ISOClase6 ISOClase7 ISOClase8 ISOClase93 Lmitesm ximosdeconcentracin(P articulas/ m deaire)departiculas" iguales a" y" mayoresque" lostamaosm ostradosabajo >=0.1m >=0.2m >=0.3m >=0.5m >=1m >=5.0m 10 2 100 24 10 4 1.000 237 102 35 8 10.000 2.370 1.020 352 83 100.000 23.700 10.200 3.520 832 29 1.000.000 237.000 102.000 35.200 8.320 293 352.000 83.200 2.930 3.520.000 832.000 29.300 35.200.000 8.320.000 293.000

ComparacinentrelasclasesequivalentesdelFederalStandard209ydelaI SO146441 ClaseI SO146441 FederalStandard Clase3 Clase1 Clase4 Clase10 Clase5 Clase100 Clase6 Clase7 Clase1.000 Clase10.000 Clase8 Clase100.000

ClasificacindelA ireenlaUninEuropea,guaparaBuenasP rcticasdeFabricacin3 N umerom ximodepartculaspermitidasxm igualesaosobre Grado endescanso enoperacin >=0.5m >=5.0m >=0.5m >=5.0m A 350 0 3.500 0 B 3.500 0 350.000 2.000 C 350.000 2.000 3.500.000 20.000 D 3.500.000 20.000notdefined notdefined

N ote GradoAyBcorrespondeaclase100,M3.5,ISO5 GradoCcorrespondeaclase10000,M5.5,ISO7 GradoDcorrespondeaclase100000,M6.5,ISO8

ClasificacindecontaminacindeSalasLimpias Sustancia Qumica Compuestosorgnicos Salesinorgnicas Vapor Mist Fume Humo Energa Biolgica Bacteria Hongos Esporas Polen Virus Celulasdepielhumana Trmica Luz Electromagnetica(EMI) Electrosttica(ESD) Radiacin Electrica

Fsica Polvo Suciedad Arenilla Fibra Lint Cenizavolatil

P articulasenelaireexterior N umerodeP articulas/ m enelaireexterior TamaoenMicrones Sucio Normal Limpio >0.1 10.000.000.000 3.000.000.000 500.000.000 >0.3 300.000.000 90.000.000 20.000.000 >0.5 30.000.000 7.000.000 1.000.0003

CalendariodetestsOBLI GA TORI OSparademostrarelcumplimientocontinuodesalaslimpias P armetro ConteodePartculas Diferenciapresinaire FlujodeAire Clase ISO5 TodaslasClases TodaslasClases M ximoI ntervalodeTiempo 6Meses 12Meses 12Meses 12Meses

CalendariodetestsOP CI ON A LESparademostrarelcumplimientocontinuodesalaslimpias P armetro InstalledFilterLeakage Fugas ContainmentLeakage Recovery AirflowVisualization Clase Todas Todas Todas Todas M ximoI ntervalodeTiempo 24Meses 24Meses 24Meses 24Meses

ComparacindeestndaresI nternacionales P asyEstndar InglaterraBS AustraliaAS Francia 5295 1386 AFNORNFX 44101 Fechadeemisin 1992 1989 1989 1981 C 0,035 D 0,35 EorF 3,5 4000 GorH 35 J 350 400000 K 3500 4000000

USA209D

USA209E

Alemania VDI2083

ISO

1988 1M1.5 10M2.5 100M3.5 1000M4.5 10000M5.5 100000M6.5

1990 1 2 3 4 5 6 3 4 5 6 7 8

1999

EUGGM P 2002LmitesrecomendadosdeContaminacinM icrobiana contact PlatesDiam GlovePrint 55mm 5fingers 3 cfu/m cfu/glove