ISO Classifications

What are ISO Cleanroom Classifications?

If you’re considering designing and constructing a cleanroom, but aren’t exactly sure what ISO classifications are, you’ve come to the right place.

Let’s air out some of the confusion.

First of all, cleanrooms are classified by how pure the air is. Specifically, classifications are designed to categorize a cleanroom by the number of particles found in the lab’s air. The cleanroom classification standard ISO 14644-1 uses particular particle count measurements to categorize the cleanliness or air purity level of a clean zone or cleanroom.

Here’s some perspective.

Outside air in a metropolitan area has about 35,000,000 particles for each cubic meter within the range 0.5 μm (μm = micrometer) and bigger in measurement, which is the equivalent of an ISO 9 cleanroom. On the other end of the ISO spectrum, an ISO 1 cleanroom allows no particles in that range (0.5 μm and bigger in measurement), and only 12 particles for each cubic meter that is 0.3 μm and smaller.

Cleanrooms are categorized according to both the size and the number of particles present per volume of air. ISO 14644-1 standards specify the decimal logarithm of the number of particles 0.1 µm or larger present per cubic meter of air.

ISO 1 for instance, has at most 10 particles per m³ (cubic meter) and ISO class 4 cleanroom has at most 10,000 particles per m³.

What do cleanroom classifications mean?

Cleanroom classifications define the level of air cleanliness in a controlled environment. Each class is based on the number of particles of a certain size allowed per cubic meter of air. Lower classes like ISO Class 1 are the cleanest, while higher classes like ISO Class 9 allow more particles.

What is the difference between ISO 14644-1 cleanroom standards and US FED STD 209E?

ISO 14644-1 is the current global standard, measuring particles per cubic meter of air. The older US FED STD 209E used particles per cubic foot and is still commonly referenced. A cleanroom class comparison is often used to translate between the two systems for compliance.

What industries require specific ISO cleanroom classes?

Different industries follow different standards. For example:

ISO Class 5–7 for pharmaceutical cleanrooms (USP 797 & 800).

ISO Class 4–6 for semiconductor and electronics.

ISO Class 7–8 for medical devices, aerospace, and general research labs.

How does Allied Cleanrooms ensure compliance with cleanroom classifications?

At Allied Cleanrooms, we build modular cleanrooms engineered to meet your required ISO cleanroom classes. Our facilities are designed, manufactured, and installed in the U.S., ensuring full compliance with ISO 14644-1 cleanroom standards, USP regulations, and cGMP requirements.

  • 35+ years of experience
  • Compliance for ISO, FDA, cGMP, USP, and many other standards
  • Coast-to-coast service
  • In-house design, engineering, and manufacturing