Cleanroom Classification Levels
Cleanroom Classification Levels
US Federal Standard 209E Particle Levels
|
Class |
Maximum Particles per Cubic Foot of Air |
ISO Comparison |
||||
|
≥0.1 µm |
≥0.2 µm |
≥0.3 µm |
≥0.5 µm |
≥5 µm |
||
|
1 |
35 |
7 |
3 |
1 |
|
ISO 3 |
|
10 |
350 |
75 |
30 |
10 |
|
ISO 4 |
|
100 |
|
750 |
300 |
100 |
|
ISO 5 |
|
1,000 |
|
|
|
1,000 |
7 |
ISO 6 |
|
10,0000 |
|
|
|
10,000 |
70 |
ISO 7 |
|
100,000 |
|
|
|
100,000 |
700 |
ISO 8 |
Institute of Environmental Sciences and Technology (IEST)
ISO Standard 14644-1 International Standard for Cleanrooms
|
Class |
Maximum Particles per Cubic Meter of Air |
US Fed Std 209E Comparison |
|||||
|
≥0.1 µm |
≥0.2 µm |
≥0.3 µm |
≥0.5 µm |
≥1 µm |
≥5 µm |
||
|
ISO 1 |
10 |
2 |
|
|
|
|
|
|
ISO 2 |
100 |
24 |
10 |
4 |
|
|
|
|
ISO 3 |
1,000 |
237 |
102 |
35 |
8 |
|
Class 1 |
|
ISO 4 |
10,000 |
2,370 |
1,020 |
352 |
83 |
|
Class 10 |
|
ISO 5 |
100,000 |
23,700 |
10,200 |
3,520 |
832 |
29 |
Class 100 |
|
ISO 6 |
1,000,000 |
237,000 |
102,000 |
35,200 |
8,320 |
293 |
Class 1,000 |
|
ISO 7 |
|
|
|
352,000 |
83,200 |
2,930 |
Class 10,000 |
|
ISO 8 |
|
|
|
3,520,000 |
832,000 |
29,300 |
Class 100,000 |
Biosafety Levels are defined by the Centers for Disease Control (CDC) and the National Institutes of Health. There are basically 4 different levels and each different type of facility handles different types of infectious agents. Each Biosafety level accounts for operations that can be performed, known and suspected routes of transmission and Laboratory function.
Biosafety Level 1 (BSL-1)
BSL-1 is the lowest level because of the materials being handled. BSL-1 levels are appropriate for facilities that handle and work with defined and characterized strains of viable organisms that will not cause a disease reaction in healthy adult humans. Level 1 precautions are based on standard microbial practices with any special primary or secondary barriers. BSL-1 criteria are mainly for undergraduate and secondary educations laboratories.
Biosafety Level 2 (BSL-2)
BSL-2 are mainly facilities that handle a broad range of indigenous moderate-risk agents known to cause disease in humans. BSL-2 precautions are necessary when working with human blood, bodily fluids, or tissues where an infectious agent is unknown to be in the sample. Primary hazards in BSL-2 labs are in injection and ingestion.
Biosafety Level 3 (BSL-3)
BSL-3 applies to facilities that handle indigenous or exotic agents with the potential for lethal infection and aerosol transmission. The hazards in a BSL-3 lab are inhalation, autoinoculation and ingestion. BSL-3 labs precautions place an emphasis on primary and secondary barriers. For primary protection, all laboratory actions shall be performed in a biological safety cabinet or other enclosed equipment. Secondary protections include controlled access and very specialized ventilation systems in the lab.
Biosafety Level 4 (BSL-4)
BSL-4 lab precautions are required for facilities that work with dangerous and exotic agents with a high risk of causing life-threatening diseases, no known vaccine or therapy to cure and the possibility of aerosol transmission. BSL-4 samples required complete isolation. Full bodied air supplied positive pressure safety suits for personnel protection or Class III biological safety cabinets are required when processing level 4 agents. Waste management systems, isolated facilities and specialized ventilation are required in BSL-4 labs.
European Standards
Grade |
Air Changes per Hour |
|
Grade A |
480-600 |
|
Grade B |
35-70 |
|
Grade C |
20 |
|
Grade D |
20 |