ISO 7 Cleanrooms (Class 10,000)
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 |
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ISO 7 Cleanroom Filtration Requirements
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
