American Cleanroom Systems designs, builds, and installs ISO 7 modular cleanrooms (also called Class 10,000 cleanrooms) as complete turnkey projects, from engineering and fabrication through on-site installation and certification. An ISO 7 cleanroom holds no more than 352,000 particles at 0.5 microns and larger per cubic meter and runs at least 60 air changes per hour. For the full particle-count limits and standards, see our ISO 7 cleanroom classification guide.
We build ISO 7 modular cleanrooms for regulated and precision industries, including:
Figure 1. Recirculating Air flow diagram for ISO-7 modular cleanroom
What's Included in an ACS ISO 7 Cleanroom
A typical ISO 7 cleanroom from American Cleanroom Systems includes:
- Gowning room and air locks
- Product pass-throughs
- Heat-welded vinyl or epoxy floors
- Air conditioning for temperature control
- HEPA fan filter units
- Sealed cleanroom lighting
- Magnehelic gauge for room air-pressure monitoring
- Non-particulating gowning (bunny suits, booties, and hoods)
- Air showers at entry, where the application calls for it
- Sticky mats at the entrance and exit
- Stainless steel benches and hands-free sinks
- Gown racks
Figure 2. ISO-7 modular cleanroom – medical device
ISO 7 Hardwall (Modular) Cleanroom Design
Our standard hardwall, modular ISO 7 cleanroom design features:
- Negative-pressure plenum
- Ceiling-mounted HEPA fan filter units
- Low wall air returns for laminar airflow
- Cleanable modular walls
Figure 3. Softwall cleanroom
Softwall Class ISO-7 cleanroom option:
For lighter-duty or temporary needs, a softwall ISO 7 cleanroom is a lower-cost option:
- Clear, flexible vinyl curtain walls
- Clear vinyl strip curtain at the entrance
- Painted steel or anodized aluminum frame
- Ceiling-mounted HEPA fan filter units
- Ceiling-mounted lighting
- Casters on smaller units
Softwall ISO 7 limitations:
- No temperature control
- No measurable positive pressure
- Walls cannot be wiped down
Typical softwall ISO 7 applications:
- Inside an ISO 8 hardwall cleanroom
- Inside a warehouse
- Weighing product during packaging
- Inspection stations
- Temporary cleanrooms
ISO 14644-1 Cleanroom Standards | Cleanroom Classifications
| 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 |
| ISO 9 |
|
|
|
35,200,000 |
8,320,000 |
293,000 |
Room Air |
Figure 4. ISO cleanroom classification table
FAQs About ISO-7 Cleanrooms
Q: What is the Difference Between an ISO-7 and an ISO-6 Cleanroom?
A: An ISO-7 cleanroom is allowed a maximum of 2,930 particles/m3 greater than 5 microns and less than 352,000 particles/m3 greater than 0.3 um. An ISO-7 cleanroom must have at least 60 air changes per hour. An ISO-6 cleanroom is allowed a maximum of 293 particles/m3 greater than 5 micron and less than 35,200 particles/m3 greater than 0.3 um. An ISO-6 cleanroom must have at least 180 air changes per hour. An ISO-7 cleanroom classification is closest to Class 10,000 Fed Std 209E . An ISO-6 cleanroom classification is closest to Class 1000 Fed Std 209E.
Q: What is an ISO-8 Cleanroom?
A: An ISO-8 cleanroom is allowed a maximum of 29,300 particles/m3 great than 5 microns and less than 3,520,000 particles/m3 great than 0.3 microns. An ISO-8 cleanroom must have at least 20 air changes per hour. An ISO-8 cleanroom classification is closest to Class 100,000 cleanroom classification.
Q: What Does the Term ISO-4 Cleanroom Mean?
A: An ISO-4 cleanroom is allowed no particles greater than 5 microns, less than 352 particles/m3 greater than 0.5 um and less than 1,020 particles/m3 great than 0.3 microns. ISO-4 cleanrooms have between 500 to 600 air changes per hour. An ISO-4 cleanroom classification is closest to class 10. ISO-4 cleanrooms typically use ULPA filters and have 100% ULPA filter ceiling coverage.
Q: What are Cleanroom Requirements?
A: Cleanroom requirements typically refer to cleanroom classification, length, width, height, wall type, air flow of either recirculating or one pass, temperature, humidity, and room pressure. Other requirement can be related to exhaust, chemical resistance, biohazard, electrical discharge, or light frequency.
Q: What is an ISO-5 Cleanroom?
A: An ISO-5 cleanroom is allowed 29 particles/m3 greater than 5 microns, less than 3,520 particles/m3 greater than 0.5 um and less than 10,200 particles/m3 great than 0.3 microns. An ISO-5 cleanroom must have more than 300 air changes per hour and typically has at least 70% HEPA filter ceiling coverage. An ISO-5 cleanroom classification is closest to class 100.
Q: What is the Highest-Class Cleanroom?
A: ISO-9 is considered the high ISO cleanroom classification. The particle counts correspond to room and is roughly 10x as dirty as ISO-8. Class 100k is the highest FED Std 209E cleanroom classification. Class 100k is closest to ISO-8.
Q: What are the Classes of Cleanrooms?
A: The Fed Std. 209E cleanroom classifications are class 100,000 (class 100k) , class 10000 (class 10k), class 1000 and class 100. The ISO cleanroom classifications are ISO-5, ISO-6, ISO-7 and ISO-8.
Q: What is an ISO-7 Cleanroom?
A: An ISO-7 cleanroom is allowed a maximum of 2,930 particles/m3 greater than 5 microns and less than 352,000 particles/m3 greater than 0.5 um. An ISO-7 cleanroom must have at least 60 air changes per hour, have ceiling mounted HEPA fan filter units and low all air returns.
Q: What ISO Class is a Cleanroom?
A: The ISO class of cleanroom is defined by how many particles per cubic meter and how many air changes per hour with hepa filtered air.
Q: How are Cleanrooms Classified?
A: Cleanrooms are classified by particle count and HEPA filtered air changes per hour. Particle counts range from 0 to 29,300 particles/m3 greater than 5 um, and air changes from 20 to 300 air changes per hour. For example, a ISO-8 cleanroom is allowed 29,300 particles/m3 greater than 5 microns, 3,520,000 particles/m3 greater than 0.3 microns and minimum 20 air changes per hour. Fed Std 209E cleanroom classifications are also by particle count and HEPA filtered air changes per hour. However, the particle counts are by feet3.
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