What is an ISO Class 8 cleanroom?

What is an ISO Class 8 cleanroom?

ISO 8 is the least clean cleanroom classification. A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty.

What are cleanrooms used for?

A cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out in order to provide the cleanest area possible. Most cleanrooms are used for manufacturing products such as electronics, pharmaceutical products, and medical equipment.

What is a Grade B clean room used for?

The Grade B cleanroom environment of your GMP facility is used for aseptic preparation and filling.

WHO GMP clean room classification?

Cleanroom Limits for Airborne Particulate Contamination

Cleanroom Standard Maximum permitted number of particles /m³
EU GMP Grade ISO 14644-1 In operation ≥0.5µm
A 5 3,520
B 5 352,000
C 7 3,520,000

What is the difference between ISO 7 and ISO 8?

ISO Class 8 cleanrooms typically have between 10-25 air changes every hour, while ISO Class 7 have between 30-60. That means that in our ISO Class 7 Cleanroom, the air is filtered at least thirty times every hour. Particles are consistently filtered out to provide clean air for medical device production.

Is ISO 5 cleaner than ISO 7?

This article will help you understand the basic differences between an ISO 5, ISO 6, ISO 7 and ISO 8 clean room as per ISO 14644….

ISO Class Average number of air changes per hour
ISO 5 240–360 (unidirectional air flow)
ISO 6 90–180
ISO 7 30–60
ISO 8 10–25