Cleanroom validation

Cleanroom validation and periodic Re-Certification/Re-Qualification testing in accordance with the ISO 14644 series and Eudralex, Volume 4, Annex 1. Periodic testing is important to ensure continued compliance to relevant standards and will ensure that the product manufactured is fit for its intended use. Testing is carried out at regular intervals as laid down in the ISO 14644 series which guarantees the protection of people, processes and product.

Cleanroom Validation Test

  • Airflow Volume
  • Air change rate
  • Room Pressurisation
  • Filter leak test (DOP test)
  • Non Viable particle counts
  • Temperature and Relative humidity
  • Sound and lighting levels
  • Room Recovery Rate
  • Airflow Visualisation Studies
  • Containment test
  • Monthly viable monitoring
Cleanroom classifacation image

Validation is an important process for any cleanroom. It serves to ensure that the cleanroom is properly installed and designed for its intended ISO classification and that all of the components (facility, environment, equipment) meet regulatory requirements and other defined standards.