By Anthony Chien
President, American Cleanroom Systems ®
40+ years of cleanroom design and engineering experience
Last reviewed: June 2026
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Cleanroom validation is part of FDA required drug validation process for CGMP (Current Good Manufacturing Practice). The cleanroom validation process includes design qualification, installation qualification, operational qualification and performance qualification. The cleanroom testing typically centers around ISO-14644 cleanroom classification but can also include temperature, humidity, air pressure and other conditions.
The FDA asks that a new drug or medical device meets specification and be manufactured per CGMP. This means process, procedures, intermediate stages inspections, and testing during manufacturing ensure the quality of the product being manufactured. Such procedures are developed through the process of validation. The manufacturing equipment and cleanroom are key components of the manufacturing process validation.
The cleanroom validation process
- Cleanroom Design Qualification (DQ): confirm the cleanroom design meets users needs per CGMP.
- Cleanroom Installation Qualification (IQ): confirm cleanroom and all its components (HEPA filtration, HVAC, flooring, interlocks, air showers, etc.) are installed per design.
- Cleanroom Operational Qualification (OQ): confirm via testing the cleanroom and its components work per design and achieve specified results (temperature, humidity, particle counts, air changes per hour, pressure cascade, etc.)
- Cleanroom Performance Qualification (PQ): is testing with personnel working and equipment operating that cleanroom works per design and achieves specified results (temperature, humidity, particle counts, air changes per hour, pressure cascade, etc). Often additional tests such as cleanroom HVAC recover time and cleanroom particle count recover time are done.
Cleanroom validation is part of FDA required drug validation process for CGMP. Steps are Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification. Most common tests include particle count, temperature, humidity, differential pressure and air changes per hour.
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