ISO 7 (or Class 10,000) is a mid-level cleanroom classification that specifies the maximum number of particles in a cubic meter of air. ISO 7 cleanrooms are recommended for applications that require moderate particle concentration limits.
ISO 7 Cleanroom Standards and Regulations
Cleanrooms are classified according to the number and size of particles permitted per air volume in a specific space and time. An ISO 7 or Fed-Std 209E class 10,000 cleanroom must maintain 60-150 air changes per hour with a ceiling coverage of 15-25% while meeting the following standards and regulations:
- 352,000 particles per cubic meter or less ≥0.5 µm sized particles
- 83,200 particles per cubic meter or less ≥1 µm sized particles
- 2,930 particles per cubic meter or less ≥5 µm sized particles
| Maximum Number of Particles in Air (particles per cubic meter) |
| ISO Class |
FED-STD 209E Equivalent |
Particle Size |
| >0.1µm |
>0.2µm |
>0.3µm |
>0.5µm |
>1µm |
>5µm |
| ISO 1 |
10 |
2 |
|
|
|
|
| ISO 2 |
100 |
24 |
10 |
4 |
|
|
| ISO 3 | Class 1 |
1,000 |
237 |
102 |
35 |
8 |
|
| ISO 4 | Class 10 |
10,000 |
2,370 |
1,020 |
352 |
83 |
|
| ISO 5 | Class 100 |
100,000 |
23,700 |
10,200 |
3,520 |
832 |
29 |
| ISO 6 | Class 1,000 |
|
237,000 |
102,000 |
35,200 |
8,320 |
293 |
| ISO 7 | Class 10,000 |
|
|
|
352,000 |
83,200 |
2,930 |
| ISO 8 | Class 100,000 |
|
|
|
3,520,000 |
832,000 |
29,300 |
ISO 7 Cleanroom Filtration Requirements
Class 10,000 (ISO 7) cleanrooms require
HEPA filters incorporating a negative pressure plenum with HEPA fan filter units in the ceiling with low wall air returns to achieve laminar airflow. The HEPA-filtered air sweeps dirt down to the floor and horizontally to the low wall air returns.
ISO 7 Cleanroom Airflow & Air Change Rates Per Hour (ACPH) Standards
ISO-7 cleanrooms must have turbulent airflow and 60-150 air changes per hour of HEPA-filtered air and less than 2,930 particles/meter³ greater or equal to 5 microns. Additional air change requirements include:
- Non-unidirectional airflow or mixed airflow patterns are typically used. Airflow is most commonly a vertical flow from the ceiling to the floor, returning for conditioning and filtration through low wall returns.
- Typical air changes: 60-150 air changes per hour
- Filtration Ceiling coverage is 15-20%, with a randomized array with filtration located over the highest control areas.
Common ISO 7 Cleanroom Applications
ISO 7 cleanrooms are commonly used for the following applications:
- USP797/800 compounding pharmacy
- Medical device manufacturing
- Printed Circuit board manufacturing
- Pharmaceutical solution preparation
- Pharmaceutical cream and ointment manufacturing
- Pharmaceutical liquid manufacturing
- CBD extraction
- Laser
- Precision manufacturing
- Aerospace composite repair
- Semiconductor test and packaging
- R&D
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