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10000-class clean area standard
according to the number of dust particles and to define the number of microorganisms
1.The maximum number of dust particles (per cubic meter) to allow:
Large or equal to the number of particles of 0.5 microns can not be more than 350,000,
Greater or equal to the number of particles 5 microns not more than 2000;
2.The maximum allowable number of microorganisms:
Planktonic bacteria not more than 100 per cubic meter:,
Settlement of bacteria not more than 3 per dish.
according to the number of dust particles and to define the number of microorganisms
1.The maximum number of dust particles (per cubic meter) to allow:
Large or equal to the number of particles of 0.5 microns can not be more than 350,000,
Greater or equal to the number of particles 5 microns not more than 2000;
2.The maximum allowable number of microorganisms:
Planktonic bacteria not more than 100 per cubic meter:,
Settlement of bacteria not more than 3 per dish.
| USA Federal Standard 209E(1992 Year) | |||||
| Clean standard | Particle size(um) | ||||
| 0.1 | 0.2 | 0.3 | 0.5 | 5 | |
| 10000 | NA | NA | NA | 10000 | 70.3 |
| Units: quntity of dust/ft3 | |||||
| China pharmaceutical manufacturing clean room (area) of air cleanliness standard | |||||
| Clean standard | quntity of dust/M3 | Maximum allowable quantity of microorganisms | |||
| ≥0.5um | ≥5um | Float bacteria PS/M3 | Subsidence bacteria PS/30min | ||
| 10000 | 350,000 | 2,000 | 100 | 3 | |
| China Drug Administration of August 1, 1999 issued and implemented | |||||