Demystifying Cleanrooms: Understanding Their Importance, Function, and Classification Standards

Demystifying Cleanrooms: Understanding Their Importance, Function, and Classification Standards

Cleanrooms Explained

Cleanrooms are used extensively throughout the semiconductor, biotech, and life sciences industries. But what is a cleanroom? A cleanroom is an environment, typically used in manufacturing or scientific research, that has a low (or controlled) level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical contamination. Controlling the level of contamination is critical to the operation of any cleanroom, but some cleanrooms require lower levels of contamination than others (more on that later).

Cleanrooms work by:

  • Limiting the amount of outdoor air and people let into the room. This is completed by creating a positive pressure room so that any leaks push air out of the cleanroom instead of letting contaminated air in, controlling access of who is allowed into a cleanroom, and cleaning people before they enter the room to remove any foreign pollutants (usually with an air shower).
  • Utilizing air filters (such as HEPA filters) to circulate and clean the air already in the cleanroom.
  • Controlling what types of objects are allowed into the cleanroom. Many times paper, clothes, equipment, and furniture emit contaminants - but there are products manufactured using materials that either do not contain or do not emit particulate matter. View our products made specifically for the cleanroom.
Depending on the circumstance or purpose of a cleanroom, certain levels of pollutants are allowed within a cleanroom. To give perspective, a typical urban environment contains 35,000,000 particles per cubic meter of air - which corresponds to an ISO 9 cleanroom. On the other end of the spectrum is the ISO 1 cleanroom, which allows only 12 particles per cubic meter of air. Cleanrooms are built to exact standards and use specific equipment to adhere to an ISO cleanroom classification. We’ve listed the different cleanroom classifications below:

Cleanroom Classifications

Cleanroom classifications primarily follow ISO classification system ISO 14644-1, which designates required cleanliness of the air inside the controlled environment. The best way to think about the system is ISO 1 is the “cleanest” and ISO 9 is the “dirtiest.”

Below is a useful table that outlines the ISO standards and related level of contamination.

How does GMP Labeling support the cleanroom?

GMP Labeling is a leader in compliance, documentation, and identification products in the life sciences, biotech, and medical device industries. We understand the needs our customers have when it comes to quality control, compliance, and GMP standards. GMP Labeling provides our customers with cleanroom products such as notebooks, binders, pens, sticky notes, and labels that are manufactured with specific materials, cleaned, and sealed to meet the standards of most cleanroom classifications.
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