How to Validate Your Cleanroom? ( Webinar available )

How to Validate Your Cleanroom? ( Webinar available ) Medium Image

HVAC Performance Qualification Basics

HVAC Performance Qualification Roadmap, Application Guidance, and Tips as per ISO 14644-3:2019; Cleanroom Test Methods and Cleanroom Classification as per ISO 14644-1:2015.

 

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

 

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

Cleanroom airborne particle count and classification is the only way to classify cleanroom. Classification is the method of assessing the level of cleanliness against a specification for a cleanroom or clean zone. ISO14644-1 is the only reference to evaluate cleanliness level (as ISO Class N), and there are no other tests to perform to classify cleanroom. Table 1 should be your reference for “ISO Classes of air cleanliness by particle concentration”;

The 1999 edition shows the number of sampling locations calculated. But The latest version gives us a table to check and define the number of sampling locations related to the cleanroom area.

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

Performing a  proper cleanroom performance qualification requires several “supportive tests” mentioned in ISO 14644-3:2019 “Cleanroom Test Methods” previously known as “optional tests” in the 2005 version of this ISO 14644-3 standard. All these supportive are in ISO 14644-3:2015 Table 2. Each supporting test is listed with principles (section 4), procedures (Annex B), and Apparatus (Annex C).

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Even though these tests are known as “supportive/optional” tests, you should perform the most suitable ones as per your requirement for proper cleanroom validation. The reason here is that ISO 14644 series are for all industries using cleanrooms and controlled environments. For example, electrostatic tests are critical for semiconductors and microelectronics industries but not for automotive paint shops with controlled environments. Or airflow visualization is a crucial parameter for unidirectional airflow verification at sterile production lines in pharmaceutical industries while it is not critical for medical packaging cleanroom with turbulent air.

Please sign up to our knowledge center to learn more about planning, implementation, and proper reporting for cleanroom qualifications.

 

 

 

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Sep 24, 2021