Clean Room Class Standard- Internation, China and USA

Class description of clean room

The standard class of clean room is defined as follows: Class X (at Y μm)

Where X is the class of the clean room, such as 100 or 10000, and Y is the particle size such as μm, μm, etc. This means that the user stipulates that the particle content of the clean room must meet the limit of the level at these particle sizes. Here are a few examples:

Class1 μm, μm, μm)

Class 100μm, μm)

Class 100μm, μm, μm)

In Classes 100 and Greater (Class 100, 1000, 10000…), generally one particle size is enough. In Classes Less than 100 (Class 10, 1….), it generally depends on several particle sizes.

The second is to specify the state of the clean room, for example:

Class X (at Y μm ), At-rest

The third is to customize the upper limit of particle concentration. Generally, the dust-free workshop is very clean in As-built, and the particle control ability test is not easy. At this time, you can simply lower the upper limit of acceptance, for example:

Class 10000 μm <= 10000), As-built

Class 10000 μm <= 1000), As-built

The purpose of this is to ensure that the clean room still has sufficient particle control capabilities when it is in the Operational state.

The following two tables are the grade definition of Fed-Std-209E and the grade definition of ISO-14644.

Fed-Std-209E cleanliness definition

Class Name		Class Limits
		μm		μm		μm		μm		5μm
		Volume Units		Volume Units		Volume Units		Volume Units		Volume Units
SI	U.S.	(m3)	(ft3)	(m3)	(ft3)	(m3)	(ft3)	(m3)	(ft3)	(m3)	(ft3)
M 1		350								–	–
M	1	1,240		265		106				–	–
M 2		3,500		757		309		100		–	–
M	10	12,400	350	2,650		1,060		353		–	–
M 3		35,000	991	7,570	214	3,090		1,000		–	–
M	100	–	–	26,500	750	10,600	300	3,530	100	–	–
M 4		–	–	75,700	2140	30,900	875	10,000	283	–	–
M	1,000	–	–	–	–	–	–	35,300	1,000	247
M 5		–	–	–	–	–	–	100,000	2,830	618
M	10,000	–	–	–	–	–	–	353,000	10,000	2,470
M 6		–	–	–	–	–	–	1,000,000	28,300	6,180	175
M	100,000	–	–	–	–	–	–	3,530,000	100,000	24,700	700
M 7		–	–	–	–	–	–	10,000,000	283,000	61,800	1,750

ISO-14644 cleanliness definition

ISO classification number(N)	Maximum concentration limits (particles/m3of air) for particles equal to and larger than the considered sizes shown below (concentration limits are calculated in accordance with equation (1).
					1mm	5mm
ISO Class 1	10	2
ISO Class 2	100	24	10	4
ISO Class 3	1 000	237	102	35	8
ISO Class 4	10 000	2 370	1 020	352	83
ISO Class 5	100 000	23 700	10 200	3 520	832	29
ISO Class 6	1 000 000	237 000	102 000	35 200	8 320	293
ISO Class 7				352 000	83 200	2 930
ISO Class 8				3 520 000	832 000	29 300
ISO Class 9				35 200 000	8 320 000	293 000
NOTE Uncertainties related to the measurement process requires that concentration data with no more then three significant figures be used in determining the classification level. Equation (1): Cn = 10NX D) where Cn is particle concentration, N is cleanliness, and D is particle size

Comparing the above two tables, we can draw the following conclusions:

Although there are formulas for interchange between the metric and imperial standards, it is still difficult to see their relevance. Two systems put the same table, it is easy to cause confusion
It appears in almost every grade definition in the two tables, and the particle size is very representative
In terms of the classification of cleanliness, whether it is high cleanliness or low cleanliness, the range of ISO-14644 is wider than that of 209E, so it has a future

Classification of clean room grade standards

The cleanliness level standard ISO14644 classifies the air cleanliness level in clean rooms (zones) and related controlled environments according to the only indicator of suspended particle concentration, and only considers the particle size limit (lower limit) to the cumulative distribution of particles within the range . According to the particle diameter, it can be divided into regular particles (~), ultrafine particles (<) and macro particles (>).

Air cleanliness classification standard: ISO14644-1 (international standard)

Air cleanliness classification (N)	Maximum concentration limit of particles greater than or equal to the marked particle size (pcs/m3 of air particles)
ISO Class1	10	2
ISO Class2	100	24	10	4
ISO Class3	1,000	237	102	35	8
ISO Class4	10,000	2,370	1,020	352	83
ISO Class5	100,000	23,700	10,200	3,520	832	29
ISO Class6	1,000,000	237,000	102,000	35,200	8,320	293
ISO Class7				352,000	83,200	2,930
ISO Class8				3,520,000	832,000	29,300
ISO Class9				35,200,000	8,320,000	293,000
Note: Due to the uncertainty involved in the measurement process, no more than three effective concentration figures are required to determine the level

Air cleanliness classification standard: GB/T16292-1996 (Chinese standard)

Particle size, Air cleanliness classification	Maximum allowable number of dust/m3		Larger allowable number of microorganisms
	≥	≥	Floating bacteria/m3	Settling bacteria/dish
Class 100	3,500	0	5	1
Class 1,000	35,000	200	50	2
Class 10,000	350,000	2,000	100	3
Class 100,000	3,500,000	20,000	500	10
Class 300,000	10,500,000	60,000		15

Air cleanliness classification standard: GB/T16292-1996（USA Federal Standard）

Comparison of the cleanliness level of particles in the air
Air particle cleanliness level (per cubic meter, per cubic foot) maximum concentration limit of particles

ISO14644-1	FEDSTD209E		CLASS
ISOClass	English	Metric							5um
				m3	m3	m3	ft³	m3
1			ISO1	10	2
2			ISO2	100	26	10		4
3	1		1SO3	1000	265	106		35
4	10		ISO4	10000	2650	1,060	10	353
5(百级)	100		ISO5		26500	10600		3530
6(千级)	1000		ISO6	1000000	265000	106000	1000	35300	293
7(万级)	10,000		ISO7				10000	353000	2930
8(十万级)	100,000		ISO8				100000	3530000	29300
9			ISO9				1,000,000	35300000	293000

Air cleanliness standards for clean rooms (zones) of pharmaceutical production in China

Class	Maximum allowable number of dust/m3		Larger allowable number of microorganisms
	≥	≥5um	Floating bacteria/m3	Settling bacteria/dish
100	3,500	0	5	1
10000	350,000	2000	100	3
100000	3,500,000	20,000	500	10
300000	10,500,000	61,800	NA	15

Approximate comparison table of cleanliness grades in various countries based on ≥ particle size

个/M3≥	ISO14644-1(1999)		US209D(1988)		FRANCEAFNOR(1981)	GERMANYVDI 2083(1990)
1	–	–	–	–	–	–	–
	2	–	–	–	–	0	2
	–	M1	–	–	–	–	–
	3		1	–	–	1	3
100	–	M2	–	–	–	–	–
353	4		10		–	2
1000	–	M3	–	–	–	–	–
3530	5		100	A+B	4000	3	5
10000	–	M4	–	–	–	–	–
35300	6		1000	1000	–	4	6
100000	–	M5	–	–	–	–	–
353000	7		10000		400000	5
1000000	–	M6	–	–	–	–	–
3530000	8		100000	D	4000000	6	8
10000000	–	M7	–	–	–	–	–

The cleanliness level of suspended particles in the air of clean rooms and clean areas

The cleanliness level of suspended particles in the air of clean rooms and clean areas
Air cleanliness level(N)	Greater than or equal to the maximum concentration limit of the particle size in the table (pc/m3)
					1um	5um
1	10	2
2	100	24	10	4
3	1,000	237	102	35	8
4（十级）	10000		1020		83
5（百级）	100000	23700	10200	3520	832	29
6（千级）	1,000,000	237000	102000	35200	8320	293
7（万级）				352000	83200	2,930
8（十万级）				3520000	832000	29,300
9（一百万级）					8320000	293,000
National standardGB50073-2001