A cleanroom is a regulated environment employed across numerous industries to control contamination caused by fibers, particles, microorganisms, etc., to maintain the product's or sample's integrity. ISO classes range from 1 to 9, with 1 being the cleanest. Cleanroom specifications exist so that each ISO class meets a specific standard of cleanliness. Therefore, ISO class 9 cleanroom requirements will differ from ISO class 7 cleanroom requirements.
These cleanrooms are used in a wide range of industries. Based on the level of sterility needed, they are all suited to different applications within various industries.
Cleanroom specifications, including recommended air changes per hour, airflow velocity, ceiling coverage, and particle size, are particular to certain classes of cleanrooms. They are sourced from the ISO 14644-1 international cleanroom standards.
Let’s explore the basics of cleanroom specification and industries from ISO class 9 to ISO class 4.
ISO Class 9 Cleanroom Requirements And Uses
This is the least strict cleanroom. It is sometimes used in offices or standard industrial settings. The ISO class 9 cleanroom requirements and specifications are less demanding than the other eight cleanroom classes. Specifications include:
- Recommended Air Changes Per Hour: 0-25
- Airflow Velocity: 0 – 5 ft/min
- Ceiling Coverage: 5-10%
- Particle Size: ≤ 352,000,000 particles per cubic meter at 0.5 microns or larger
ISO Class 8 Cleanroom Requirements And Uses
ISO class 8 cleanrooms are generally used in industrial or manufacturing processes, including storing packaged goods, powder handling, and packaging. Other industries can include cosmetics and vinyl printing.
They can also be used in some medical spaces where the medicine being worked with is not required to be completely sterile, including some pharmaceutical settings. Some specifications include:
- Recommended Air Changes Per Hour: 5-48
- Airflow Velocity: 1 – 8 ft/min
- Ceiling Coverage: 5-15%
- Particle Size: ≤ 35,200,000 particles per cubic meter at 0.5 microns or larger
ISO Class 7 Cleanroom Requirements And Uses
ISO class 7 cleanrooms are widely used and suitable for various applications. They are common in primary manufacturing and can be applied in multiple industries, including biotechnology, healthcare, aerospace, pharmaceuticals, nanotechnology, clinical research, and general life science sectors.
These cleanrooms are sometimes used as secondary containment rooms for cleaning stations, staging, or gowning. ISO class 7 cleanroom requirements include:
- Recommended Air Changes Per Hour: 60-90
- Airflow Velocity: 10 – 15 ft/min
- Ceiling Coverage: 15-20%
- Particle Size: ≤ 10,000,000 particles per cubic meter at 0.5 microns or larger
ISO Class 6 Cleanroom Requirements And Uses
ISO class 6 cleanrooms can be used for sensitive products. They can be used for various applications in medical devices, aerospace manufacturing, sterile compounding, and electronic manufacturing. They are also suitable for certain terminally sterilised pharmaceuticals.
- Recommended Air Changes Per Hour: 150-240
- Airflow Velocity: 25 – 40 ft/min
- Ceiling Coverage: 25-40%
- Particle Size: ≤ 1,000,000 particles per cubic meter at 0.1 microns or larger
This is an overview of the cleanroom specifications and standards for ISO class 9
to 6, among other requirements.
Cleanroom validations are essential to meeting these standards. At Vivid Air, our team offers testing services in line with the ISO 14644 international cleanroom standards.
Learn about the cleanroom specifications of ISO class 9-6 by clicking here. (Add the link to ‘here’)