TBL Plastic

Differences Between Cleanroom Classes

What is a Cleanroom?

A cleanroom is a space in which the number of contaminants in the air per unit of volume, such as dust and other airborne microbes sized between 0.1µm and 5µm, are controlled to decrease chances of contamination. These particles are controlled by a high efficiency particulate air (HEPA), which filters the air before entering the cleanroom, and it is changed multiple times per hour, according to the class of the cleanroom, as established by the International Standard Organization (ISO) 14644-1. Cleanrooms with the intention of keeping a product without contaminants are kept at a positive pressure so that the particles flow out, from the cleanest area to the least clean one. However, there are cleanrooms kept at a negative pressure in order to not let anything escape the cleanroom, such as quarantine stations and chemical testing facilities.

At TBL, we are equipped with an ISO Class 7 & Class 5 Cleanrooms. Our cleanrooms feature UV lights designed to kill most germs. These cleanrooms are utilized for assembling single-use systems packaging and injection molding.

Clean-room assembly of single-use tubing kits and manifolds. Gamma irradiation available

Cleanroom Regulations

The first cleanroom standard was the US Federal Standard 209E. This regulation separated cleanrooms into classes, Class 1 having the lowest count of particulates per cubic meter, while Class 100,000 had the highest. As cleanrooms became more prominent throughout the world, an international standard became a necessity. The International Standard Organization assembled a committee and developed the ISO 14644-1. It was based on the Federal Standard 209E, but it had two more classes before Class 1, and one more after Class 100,000 to represent room air. The ISO 14644-1 superseded the FS209E in 2015.

Current Cleanroom Classes

The table below shows how the classes are divided by the number particles allowed per cubic meter along with the range of air changes per hour in each class.

Number of Particles per Cubic Meter by Micrometer Size
Class0.1 micron0.2 micron0.3 micron0.5 micron1 micron5 micronsAir Changes per Hour
ISO 11021.020.350.0830.0029360-600
ISO 210023.710.
ISO 31,000237102358.30.29360-540
ISO 410,0002,3701,020352832.93300-540
ISO 5100,00023,70010,2003,52083229.3240-480
ISO 61,000,000237,000102,00035,2008,320293150-240
ISO 7352,00083,2002,93060-90
ISO 83,520,000832,00029,3005-48
ISO 935,200,0008,320,000293,000