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Today’s Cleanroom Standards: The Anatomy of a Modern Cleanroom

Today’s Cleanroom Standards: The Anatomy of a Modern Cleanroom

Oct 28th 2016

Cleanrooms are used in a wide variety of industries to help filter pollutants such as microbes, dust, and chemical vapors. These controlled environments, when used in conjunction with protective clothing, equipment, and practices, keep people safe while allowing manufacturing, research, and even medical procedures to be performed consistently.

To ensure this consistency, standards have been created by both the U.S. General Services Administration and International Standards Organization. The military FS209E GSA standard was used worldwide prior to the November 2001 implementation of ISO 14644-1. Although the GSA standard hasn’t been maintained in over 15 years, it’s still an important resource to understand.

Several documents have since been added, including ISO 14644-2 through 10 and ISO14698-1 through 3. These documents outline terminology and measurement units, compliance testing standards, surface and air contamination definitions, and more.

Evolution of Cleanroom Technology

Over the past two decades, cleanroom technology has been greatly refined. Improved HEPA filtration, HVAC efficiency, protective textiles, air diffusion and construction technology is improving efficiency, while smart IoT-connected sensors provide real-time monitoring and security.

In fact, the Internet of Things is one of the most important improvements to cleanroom technology, able to control everything from temperature to door locks 24/7. Organizations can now optimize and automate a large majority of cleanroom operations.

HVAC and filtration is especially important in cleanroom design, as air-change rate ranges help determine a cleanroom’s classification. The ACR is how many times per hour the volume of air in the room is replaced. In a normal home, the ACR is a maximum of 2, but cleanrooms can reach over 700.

More people accessing equipment more times requires a higher ACR to maintain ISO standards. Robotics and other automated tools assist in this process by limiting human access and environment breaches, providing a great ROI. A different ACR is also necessary depending on whether the cleanroom is as-built, at-rest, or operational.

Maintaining Cleanroom Standards

According to ISO standards, there are 8 classes of cleanrooms, with different standards required for various applications. Each of the eight ISO classes is determined by how much particulate of specific sizes exist per cubic meter. Here’s a chart for reference.

Airborne Particulate Cleanliness Classes (by cubic meter):

CLASS Number of Particles per Cubic Meter by Micrometer Size
  0.1 micron 0.2 micron 0.3 micron 0.5 micron 1 micron 5 microns
ISO1 10 2        
ISO2 100 24 10 4    
ISO3 1,000 237 102 35 8  
ISO4 10,000 2,370 1,020 352 83  
ISO5 100,000 23,700 10,200 3,520 832 29
ISO6 1,000,000 237,000 102,000 35,200 8,320 293
ISO7       352,000 83,200 2,930
ISO8       3,520,000 832,000 29,300
ISO9       35,200,000 8,320,000 293,000

The ISO standards necessary for each particular cleanroom should remain consistent across all equipment to ensure full protection. Without ISO adherence, contamination can cause equipment breakdown, quality degradation, explosion, illness, or death.

Each classification also has different testing requirements to ensure standards are being met. The following chart lists mandatory tests and frequency to maintain ISO compliance.

Required Testing (ISO 14644-2)

Schedule of Tests to Demonstrate Continuing Compliance
Test Parameter Class Maximum Time Interval Test Procedure
Particle Count Test <= ISO 5 6 Months ISO 14644-1 Annex A
> ISO 5 12 Months
Air Pressure Difference All Classes 12 Months ISO 14644-1 Annex B5
Airflow All Classes 12 Months ISO 14644-1 Annex B4

In addition to these tests, any class can perform optional tests for installed filter and containment leakage, recovery, and airflow visualization. These additional tests aren’t required for compliance but can help proactively maintain a cleanroom environment, especially in high-risk environments.

Monitoring and other cleanroom standards were updated as recently as December 2015. Much of these updates involve micro- and macroparticles as well as the procedural and operational limits and testing procedures necessary to minimize contamination.

Trusted Cleanroom Resources

At Cleanroom World, we’ve been supplying equipment, accessories, and clothing for cleanrooms in every classification across all industries for years. Suppliers and manufacturers are especially responsible for maintaining proper cleanroom standards, and we make it our responsibility to thoroughly research and distribute only the highest quality products.

Whenever new technology comes out, whether it’s new microbe filtration technology, chemical-resistant textiles, or nanoparticle-repellent materials, we’re on top of it. All equipment is fully tested, certified, and guaranteed before it ever reaches our customers.

If you’re looking to build a professional cleanroom with state-of-the-art equipment, contact Cleanroom World today to have one of our professionals walk you through the process.

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