How to validate your cleanroom? HVAC performance qualification basics

HVAC performance qualification roadmap, application guidance and tips according to ISO 14644-3:2019; test methods for cleanrooms and classification of cleanrooms according to ISO 14644-1:2015

Cleanroom HVAC performance qualification, known as “cleanroom validation”, is the most important set of tests to ensure that the cleanroom is ready for its intended use and can meet the user requirements stated at a very early stage of a built cleanroom.

What are the tests we need to perform for cleanroom classification as part of our “cleanroom validation”?

Counting and classifying airborne particles in cleanrooms is the only way to classify cleanrooms. Classification is the method of assessing the degree of cleanliness on the basis of a specification for a clean room or clean zone. ISO14644-1 is the only reference to assess the cleanliness level (as ISO Class N) and there are no other tests to classify the cleanroom. Table 1 should be your reference for “ISO Classes of Air Purity by Particle Concentration”

The number of sampling locations used to be calculated in the 1999 edition, but the latest version gives us a table to check and define no. of sampling locations related to the cleanroom area.

What are the other tests we must perform as part of the HVAC performance qualification?

In order to perform the proper qualification for cleanroom performance, there are several “supporting tests” which are mentioned in ISO 14644-3:2019 “Cleanroom test methods”, formerly known as “optional tests” in the 2005 version of this ISO 14644- 3 standard. All these supporting tests are documented in ISO 14644-3:2015 Table 2. Each supporting test is listed with principles (Section 4), procedures (Appendix B) and equipment (Appendix C).

Even these tests are known as “supportive/optional” tests, for proper cleanroom validation you need to run the most suitable one according to your requirements. The reason for this is that the ISO 14644 series is intended for all industries that use cleanrooms and controlled environments. For example, electrostatic testing is critical for the semiconductor and microelectronics industries, but not for controlled environment automotive paints. Or, airflow visualization is an important parameter for unidirectional airflow verification on sterile production lines in the pharmaceutical industry, while it is not essential for medical packaging cleanrooms with turbulent air.

For more information on planning, implementation and proper reporting for cleanroom qualifications, Then sign up at our knowledge center.

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