Facts and Fiction in Cleanroom Metrology

Abstract

This article discusses a number of cleanroom qualification parameters in terms of their proper specification. A critical analysis reveals that the useful operating range of some parameters is not appropriately considered by some early standards and guidelines, which are still used by regulatory authorities (the US Food and Drug Administration (FDA) and the European Union (EU)) and industry professionals. In practice, the windows of safely controlled cleanroom operation prove to be considerably larger than anticipated by existing regulations, especially with regard to unidirectional airflow velocity, pressure difference, and other parameters. Many measuring techniques, such as installed HEPA filter integrity testing and recovery time testing, are also regulated more strictly than necessary. Modern cleanroom testing requires more carefully defined targets and more flexibility in using advanced test procedures.