ISO 5 Cleanroom (Class 100) Regulations
ISO 5 Cleanroom Requirements, Standards & Regulations
Cleanrooms are classified according to the number and size of particles permitted per air volume in a specific space and time. An ISO 5 class 100 cleanroom must maintain 240-600 air changes per hour with a ceiling coverage of 35-70% while meeting the following standards and regulations:- 100,000 particles per cubic meter or less ≥0.1 µm sized particles
- 23,700 particles per cubic meter or less ≥0.2 µm sized particles
- 10,200 particles per cubic meter or less ≥0.3 µm sized particles
- 3,520 particles per cubic meter or less ≥0.5 µm sized particles
- 835 particles per cubic meter or less ≥1 µm sized particles
- 29 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 5 Cleanroom Filtration Requirements
ISO class 5 cleanrooms demand a high level of air cleanliness, achieved through advanced filtration systems. The filtration requirements focus on minimizing airborne contaminants to maintain compliance with the stringent standards outlined in ISO 14644-1.
Air Change Rates for ISO 5 Class 100 Cleanrooms
ISO 5 cleanroom requirements dictate 240-600 air changes per hour to rapidly replace contaminated air with filtered air to maintain cleanliness levels on par with ISO 5 requirements. These air changes are accomplished through laminar airflow that ensures unidirectional air movement that rapidly removes contaminants.HEPA & ULPA Filtration
ISO 5 cleanrooms utilize high-efficiency particulate air (HEPA) filters or ultra-low particulate air (ULPA) filters to remove 99.99% or more of particles. These filters are installed within the ceiling structure of the cleanroom to ensure uniform air distribution.Strict Environmental Controls
Class 100 cleanrooms demand regulated temperature, humidity, and pressure to maintain a stable environment. Positive pressure is also used to prevent outside contaminants from entering the cleanroom’s controlled environment.Gowning Specifications
Protective measures such as coveralls, hoods, gloves, booties, and other protective apparel must be used to ensure a stable class 100 environment is maintained within the enclosure to minimize contamination.Specialized Construction
ISO 5 cleanrooms are built with smooth, non-porous surfaces that minimize particle accumulation and allow for easy cleaning. The structure’s seamless flooring and walls also reduce contamination risks.ISO Class 5 Cleanroom Industries Served
NCI offers modular cleanrooms ranging from ISO 4 (class 10) to ISO 8 (class 100,000). Our ISO 5 (class 100) cleanrooms are commonly used within the following industries:- Pharmaceutical
- Biotechnology
- Semiconductor Manufacturing
- Medical Device Production
- Aerospace