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What is a Cleanroom? A Simple Guide

Cleanrooms are important to businesses and organizations of all kinds. They are especially useful in industries such as pharmaceutical research and manufacturing, semiconductors, aerospace, and healthcare. In this article, we’ll cover what cleanrooms are, how they’re classified, and why they’re important.

What is a Cleanroom?

A cleanroom is a controlled environment designed to reduce and remove contaminants such as dust, microorganisms, and vapors. The purpose of a cleanroom is to limit the size and number of particles in a space, which makes it “clean,” so to speak. In some industries, such as aerospace and semiconductors, a single particle can cause major problems with products. As a result, cleanrooms have become necessary in improving product safety.

A modular cleanroom applications.

Cleanroom Classifications

Cleanrooms are classified based on the number and size of particles allowed per unit volume of air. The International Organization for Standardization (ISO) defines classifications in its ISO 14644-1 standard.

ISO 14644-1 cleanroom classifications chart.

ISO vs. Federal Standard 209E

Historically, the Federal Standard 209E was the go-to classification system. It categorized cleanrooms based on the size and number of particles per cubic foot of air, rather than per cubic meter, as is this case with ISO classifications.

Today, the International Organization for Standardization (ISO) 14644-1 standard has replaced Federal Standard 209E. Though the Federal Standard 209E is no longer relevant, terms like “Class 10,000” or “Class 1,000” are still used for ease of reference.

Here is a table showing how the two standards are related.

ISO-146441 cleanroom standards table.

Components of a Cleanroom

A cleanroom’s success depends on several factors. Here are a few important ones considered in cleanroom designs:

  • Surface materials: Walls, ceilings, and floors should be made from smooth, non-shedding, and non-porous materials. This is done to make surfaces easy to clean and to prevent particles from accumulating in hidden or hard-to-reach places.
  • Filtration systems: Advanced filters allow cleanrooms to remove problematic particles with ease. High-efficiency particulate air (HEPA) filters remove 99.97% of particles larger than 0.3 micrometers, while ultra-low particulate air (ULPA) filters remove particles bigger than 0.12 micrometers. Choosing the right filters depends on the size of the particles you need to avoid.
  • Environmental controls: Special systems control temperature, humidity, and airflow. The specific environmental needs of each cleanroom may be different, depending on the industry.
  • Personnel and material entry/exit systems: Air showers, pass-throughs, and personnel protocols can prevent contaminants from entering or leaving cleanrooms.

Types of Cleanrooms

Hardwall Cleanrooms

Hardwall cleanrooms have, well, hard walls. They are made of materials like steel or aluminum, and they are more durable than their softwall counterparts. They are, in general, better at environmental control than softwall cleanrooms.

Modular cleanrooms are one type of hardwall cleanroom, and they are prefabricated in a factory before being delivered. They are more flexible and can be installed quickly, while permanent structures may take significantly longer to construct. Typically, modular cleanrooms are better for organizations that may need to change, adapt, or expand their environments at a later date.

Softwall Cleanrooms

Softwall cleanrooms, on the other hand, use soft materials for walls, such as vinyl curtains.

These cleanrooms are generally much cheaper, though they are not as effective as hardwall cleanrooms. As a result, they are typically used in less strict ISO classes, such as ISO 7 or 8.

Like modular cleanrooms, they can be easily moved or expanded.

A softwall cleanroom made of aluminum and vinyl.

Applications of Cleanrooms

Cleanrooms are used in a variety of industries. Here a few industries that rely heavily on them:

  • Pharmaceuticals and biotech: Drug manufacturing can be dangerous if certain particles or germs contaminate the products. As a result, cleanrooms are necessary for making safe medicines.
  • Semiconductor and electronics manufacturing: In these industries, even a single particle can ruin a component.
  • Aerospace and defense: In these industries, too, even small particles can cause catastrophic malfunctions with parts, which makes avoiding contamination a matter of life and death.
  • Healthcare and medical devices: Sterile conditions are necessary in these industries because contamination can lead to infections in patients or failure in equipment.
  • Food and beverage: Cleanrooms prevent bacteria, mold, and other germs from getting into food products so that they are safe to eat or drink.

Cleanroom Protocols and Practices

Successful cleanroom operation relies on many routine protocols, including:

  • Proper gowning procedures: Wearing gloves, face masks, and coveralls to prevent human-borne contamination (via skin cells, hair, or other contaminants) into the cleanroom.
  • Cleaning and maintenance protocols: Regular cleaning with non-shedding wipes and approved chemicals.
  • Monitoring and testing: Routine particle counting and microbial testing.
  • Risk management: Risk assessments help identify possible contamination issues.

The Bottom Line

Cleanrooms are essential for organizations and businesses that need to avoid certain particles, whether viable or non-viable. Given the recent advances in cleanroom technology, these spaces are becoming better and better at preventing contamination, and their importance will only continue to grow as components shrink. If you’re considering a cleanroom for your organization, get a free quote from Allied Cleanrooms today.

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