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Cleanroom Classification: ISO 14644-1

ISO CLASS 6 ACH to ISO CLASS 9 PARTICLES

Cleanroom classification data including ISO 14644-1:2015 particle count limits for Classes 1-9, air change rate guidelines, pressure differentials, temperature/humidity ranges, gowning requirements, and EU GMP Annex 1 (2022) Grade A/B/C/D records

Manufacturingclassification standard: ISO 14644-18 rowsPage 2 of 2
classification standardrecord idach max (changes/hr)ach min (changes/hr)ach noteseu gmp gradefed std 209e equivalentgowning descriptiongowning leveliso classmonitoring frequencyparticles 0 1um per m3 (particles/m3)particles 0 2um per m3 (particles/m3)particles 0 3um per m3 (particles/m3)particles 0 5um per m3 (particles/m3)particles 1 0um per m3 (particles/m3)particles 5 0um per m3 (particles/m3)pressure differential pa min (Pa)pressure differential pa typical (Pa)pressure typerecovery time min (min)rh pct max (%RH)rh pct min (%RH)standardtemp c max (degC)temp c min (degC)typical applications
ISO 14644-1ISO CLASS 6 ACH240150Turbulent HEPA; 25-40% ceiling coverageCleanroom gown; hood; gloves; shoe covers; face mask36Every 6 months classification; periodic viable monitoring1215positive55030ISO 14644-1:2015; IEST-RP-CC012.3; ASHRAE Applications 2023 Ch.192220Semiconductor back-end; medical device assembly; hard disk drive components; ophthalmic manufacturing
ISO 14644-1ISO CLASS 6 PARTICLES100061,000,000237,000102,00035,2008,320293ISO 14644-1:2015
ISO 14644-1ISO CLASS 7 ACH15060Turbulent HEPA; 15-25% ceiling coverageC10000Cleanroom gown; hood; gloves; dedicated shoes or shoe covers; face mask37Every 6 months classification; viable monitoring per risk assessment352,00083,2002,9301015positive156030ISO 14644-1:2015; EU GMP Annex 1 2022; FDA Guidance Sterile Drug Products 2004; IEST-RP-CC012.32418Pharmaceutical non-sterile mfg (Grade C); semiconductor assembly; medical device cleanroom; aerospace component assembly
ISO 14644-1ISO CLASS 7 PARTICLESC at rest100007352,00083,2002,930ISO 14644-1:2015
ISO 14644-1ISO CLASS 8 ACH2510Turbulent HEPA; 5-15% ceiling coverageD100000Dedicated garments; hair cover; shoe covers or dedicated shoes28Annual or biannual classification; basic environmental monitoring3,520,000832,00029,300510positive306530ISO 14644-1:2015; EU GMP Annex 1 2022; FDA Guidance Sterile Drug Products 2004; IEST-RP-CC012.32618Pharmaceutical support areas (Grade D); tablet manufacturing; medical device packaging; food processing; automotive paint booths
ISO 14644-1ISO CLASS 8 PARTICLESD at rest10000083,520,000832,00029,300ISO 14644-1:2015
ISO 14644-1ISO CLASS 9 ACH205Minimal HVAC filtration; conventional HVACNormal work attire with basic hair cover and shoe covers if needed19Annual; basic area monitoring35,200,0008,320,000293,000positive7030ISO 14644-1:2015; ASHRAE Applications 2023 Ch.192816Controlled manufacturing areas; general assembly; background corridor areas adjacent to cleanrooms
ISO 14644-1ISO CLASS 9 PARTICLES935,200,0008,320,000293,000ISO 14644-1:2015

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