The Cleanroom Validation Process

by Technical Air Products

cleanroom validation

One of Technical Air Products’ most frequently asked questions is: How long does cleanroom installation take? It’s obviously important to anyone investing in a cleanroom to know how long it will take before the room can be up and running. Part of this process is installation, and the other part is the cleanroom validation process. In this blog we will discuss what cleanroom validation is and why it’s important. 

What Is Cleanroom Validation?

Once your cleanroom is installed, it will require testing and certification. Cleanroom validation is the process that ensures that the cleanroom was properly designed and installed. Based on the needs of your industry, your cleanroom will have to meet a certain standard of cleanliness. ISO international standards classify how many particles of a certain size are allowed in the cleanroom. This is what validation determines. 

In most cases the validation process is performed by third-party agencies. The process begins with design qualification and ends in final certification. There are multiple steps involved, including a thorough inspection and a number of tests. The tests they perform include: 

  • Airflow volume and velocity
  • HEPA/ULPA filter leak testing 
  • Air movement visualization or smoke testing
  • Airborne particle count tests
  • Relative humidity
  • Temperature
  • Room pressurization
  • Room recovery

The certification process also has several phases. Phase 1 is the installation qualification, also known as “as built” testing. This tests to see if the room works according to design but without any employees, equipment, or materials in the room. It determines whether the installers did their job correctly and all the cleanroom components are in proper working order.

Phase 2 is the operational qualification, also known as “at rest” testing. This tests the cleanroom to see if it works properly with equipment installed in the room but without anyone working in it. The evaluators want to see that the cleanroom operates under ideal environmental conditions. 

Phase 3 is the performance qualification. This phase tests to see if the equipment works when the room is used as it is intended to be with all equipment installed and operating and workers present and performing as they need to. If a cleanroom passes this inspection, the evaluators know that the installation was done correctly and it can be used according to the needs of the organization, providing the required level of cleanliness. 

By testing in three phases, if there are problems with installation or cleanroom equipment, these can be identified and adjusted as needed. When this certification is complete, the room can be used. 

That does not mean that all testing is over, however. It’s important for any business or organization with a cleanroom to regularly recertify the room to ensure that it continues to operate the way it was designed and built to. Annual recertification is recommended, and many industries require that it occur several times a year or even quarterly. 

If you have questions about cleanroom design or operation, Technical Air Products can answer them. We offer softwall and rigidwall modular cleanrooms, and we can also design a cleanroom to meet ISO or other standards. Contact us for more information. 

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