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Cleanroom cleanliness classification for various industries

2023-12-27

■ US Federal Standard ( USA Federal Standard ) 209E （ 1992 Year）

Cleanliness Level	Particle Diameter (um)
	0.1	0.2	0.3	0.5	5.0
1	35.0	7.50	3.00	1.00	NA
10	350	75.0	30.0	10.0	NA
100	NA	750	300	100	NA
1000	NA	NA	NA	1000	7.0
10000	NA	NA	NA	10000	70.3
100000	NA	NA	NA	100000	700

Unit: Number of dust particles/ft3

■ Air cleanliness standards for cleanrooms (areas) in China's pharmaceutical production

Cleanliness Level	Maximum allowable number of dust particles / Square meters		Maximum allowable number of microorganisms
	≥0.5um	≥5um	Floating bacteria count/cubic meter	Sedimentary bacteria count/dish.30min
100	3500	0	5	1
10000	350,000	2,000	100	3
100000	3,500,000	20,000	500	10
300000	10,500,000	61,800	NA	15

Issued and implemented by the State Drug Administration on August 1, 1999

■ Based on ≥0.5um Approximate comparison table of cleanliness levels of various countries based on particle size

pcs/M ³ ≥0.5um	ISO 14644-1(1999)	US 209E(1992)	US 209D(1988)	EEC GGMP(1989)	FRANCE AFNOR(1981)	GERMANY VDI 2083(1990)	JAPAN JAOA(1989)
1	-	-	-	-	-	-	-
3.5	2	-	-	-	-	0	2
10.0	-	M1	-	-	-	-	-
35.3	3	M1.5	1	-	-	1	3
100	-	M2	-	-	-	-	-
353	4	M2.5	10	-	-	2	4
1,000	-	M3	-	-	-	-	-
3,530	5	M3.5	100	A+B	4,000	3	5
10,000	-	M4	-	-	-	-	-
35,300	6	M4.5	1,000	1,000	-	4	6
100,000	-	M5	-	-	-	-	-
353,000	7	M5.5	10,000	C	400,000	5	7
1,000,000	-	M6	-	-	-	-	-
3,530,000	8	M6.5	100,000	D	4,000,000	6	8
10,000,000	-	M7	-	-	-	-	-

■ Cleanliness level of suspended particles in the air of cleanrooms and clean areas

Air Cleanliness Level (N)	Greater than or equal to the maximum concentration limit of the particle size in the table (pc/m ³)
	0.1um	0.2um	0.3um	0.5um	1um	5um
1	10	2
2	100	24	10	4
3	1000	237	102	35	8
4	10000	2370	1020	352	83
5	100000	23700	10200	3520	832	29
6	1000000	237000	102000	35200	8320	293
7				352000	83200	2930
8				3520000	832000	29300
9				35200000	8320000	293000

National Standard GB50073-2001

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