Clean room standard

February 10, 2021

Clean room test guidelines
In order to prove that the clean room works satisfactorily, it must be proven that it meets the requirements of the following guidelines:
1. The clean room has sufficient air supply to dilute or eliminate the pollution generated indoors.
2. The air in the clean room flows from the clean area to the area with poor cleanliness. The flow of the polluted air is at a minimum, and the flow direction of the air at the door and in the indoor building is correct.
3. The air supply in the clean room does not significantly increase indoor pollution.
4. The state of motion of the indoor air ensures that there is no high concentration area in the closet.

If the clean room meets the requirements of these guidelines, it can measure its particle concentration or microbial concentration (if necessary) to determine that it meets the specified clean room standards.

Clean room test:
1. Air supply volume and exhaust air volume: If it is a turbulent clean room, measure the air supply volume and exhaust air volume. If it is a one-way flow clean room, measure its wind speed.
2. Airflow control between zones: To prove that the direction of airflow between the zones is correct, that is, from the clean zone to the zone of poor cleanliness, it must be tested: (1) the pressure difference in each zone is correct; (2) at the doorway or wall At the opening of the floor, etc., the airflow moves in the correct direction, that is, from the clean area to the area with poor cleanliness.
3. Filter leak detection: The high-efficiency filter and its outer frame should be inspected to ensure that suspended pollutants will not pass through: (1) the damaged filter; (2) the gap between the filter and its outer frame; (3) Other parts of the filter device invade the room.
4. Isolation Leak Detection: This test is to demonstrate that suspended contaminants do not penetrate the clean room through building materials.
5. Indoor airflow control: The type of airflow control test depends on the airflow mode of the cleanroom—whether it is turbulent or unidirectional. If the clean room airflow is turbulent, it must be verified that there is no area in the room where there is insufficient airflow. If it is a one-way flow clean room, it must be verified that the wind speed and direction of the entire room meet the design requirements.
6. Suspended particle concentration and microbial concentration: If these tests meet the requirements, the particle concentration and microbial concentration (if needed) are finally measured to verify that they meet the technical requirements for clean room design.
7. Other tests: In addition to these tests for pollution control, one or more of the following tests must be performed:

● Temperature ● Relative humidity ● Indoor heating and cooling capacity ● Noise value ● Illuminance ● Vibration value

Clean room cleanliness reference standard
â–  US Federal Standard 209E (1992)
Cleanliness level Particle size (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 / ft3

â–  Air cleanliness standards for clean rooms (districts) in China's pharmaceutical production

Cleanliness level The most permissible dust / cubic meter Maximum allowable number of microorganisms
≥0.5um ≥5um Floating bacteria / cubic meters Settling bacteria / 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

The State Drug Administration issued the implementation on August 1, 1999.

â–  Clean room and clean area airborne cleanliness level

Air cleanliness level (N) Greater than or equal to the maximum concentration limit of the particle size in the table (pc/m3)
0.1um 0.2um 0.3um 0.5um 1um 5um
1 10 2
2 100 twenty four 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

■ Approximate comparison table of national cleanliness grades based on particle size ≥0.5um


/M3≥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 M6.5 100,00 D 4,000,000 6 8
10,000,000 - M7 - - - - -

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