A cleanroom is used in many industries to prevent contamination of samples or products via a controlled environment. Each class, ranging from ISO 1 to 9, has its own cleanroom specifications. These are based on various uses within several industries and expected cleanliness levels. From 9 downwards, 9 is the ‘dirtiest’ controlled environment, while 1 is the most pristine.
Cleanroom specifications, found in the ISO 14644-1 international cleanroom standards, include recommended air changes per hour, airflow velocity, ceiling coverage, and particle size.
Let’s explore the basics of cleanroom specification and industries from ISO class 5 to ISO class 1.
ISO Class 5 Cleanroom Requirements And Uses
The ISO class 5 cleanroom is used for various applications in nanotechnology, pharmaceuticals, electronic manufacturing, and biotechnology. Some specific fields in which they are used include solar panel manufacturing and active medical devices.
Cell culture research and nonsterile or sterile pharmaceutical compounding customarily require ISO class 5 cleanrooms. Specifications include:
- Recommended Air Changes Per Hour: 240-480
- Airflow Velocity: 40 – 80 ft/min
- Ceiling Coverage: 50-90%
- Particle Size: ≤ 100,000 particles per cubic meter at 0.1 microns or larger
ISO Class 4 Cleanroom Requirements And Uses
ISO class 4 cleanrooms tend to be used in areas requiring high cleanliness levels, such as biotechnology control areas and nanotechnology. They are also used for applications in electronics manufacturing, optics, and displays. Specifications include:
- Recommended Air Changes Per Hour: 300-540
- Airflow Velocity: 50 – 90 ft/min
- Ceiling Coverage: 50-90%
- Particle Size: ≤ 10,000 particles per cubic meter at 0.1 microns or larger
ISO Class 3 Cleanroom Requirements And Uses
ISO class 3 is used for spaces that need to sustain a radically low particle count and extremely sensitive production processes. These include applications within the satellite industry, electronic manufacturing, and spaces employed for nanofabrication. Specifications include:
- Recommended Air Changes Per Hour: 360-540
- Airflow Velocity: 60 – 90 ft/min
- Ceiling Coverage: 60-100%
- Particle Size: ≤ 1,000 particles per cubic meter at 0.1 microns or larger
ISO Class 2 Cleanroom Requirements And Uses
ISO class 2 cleanrooms border on the most sterile. They are used in various applications in industries such as computer and electronic part manufacturing and the semiconductor sector. They are used specifically where the most sensitive manufacturing processes are carried out. Specifications include:
- Recommended Air Changes Per Hour: 360-600
- Airflow Velocity: 60 – 100 ft/min
- Ceiling Coverage: 80-100%
- Particle Size: ≤ 100 particles per cubic meter at 0.1 microns or larger
ISO Class 1 Cleanroom Requirements And Uses
The ISO class 1 cleanroom is one of the most pristine man-made spaces. It is required for the most delicate production processes in electronic manufacturing, ultra-fine particulate processing, and nanotechnology research. Some ISO class 1 cleanroom specifications include:
- Recommended Air Changes Per Hour: 360-600
- Airflow Velocity: 60 – 100 ft/min
- Ceiling Coverage: 90-100%
- Particle Size: ≤ 10 particles per cubic meter at 0.1 microns or larger
This is a basic introduction to ISO cleanroom specifications, standards, and more for ISO classes 5 to 1. Cleanroom validations are vital to ensuring that these environments meet all these requirements.
Vivid Air validations are in alignment with SO 14644 international cleanroom standards. This includes HEPA Integrity Filter testing / DOP testing, particle count testing, and velocity testing.
Click here (add a link to ‘here’) to learn about the cleanroom specifications for ISO classes 9 to 4.
