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 | ||||||
