Cleanroom standards

Cleanroom standards

Before the ISO 14644 family of standards were developed different classifications were applied to cleanrooms and it was widely recognised that a single standard for cleanroom classification and testing was required and the first document of ISO 14644 was published in 1999, ISO 14644-1.

The ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. On November 29, 2001, 209E was cancelled and superseded by ISO 14644-1 and ISO 14644-2.

Cleanrooms

ISO 14644

  • ISO 14644-1: Classification of air cleanliness
  • ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
  • ISO 14644-3: Test Methods
  • ISO 14644-4: Design, Construction, and Start-up
  • ISO 14644-5: Operations
  • ISO 14644-6: Vocabulary
  • ISO 14644-7: Separative devices (clean air hoods, glove-boxes, isolators and mini-environments
  • ISO 14644-8: Classification of airborne molecular contamination
  • ISO 14644-9: Classification of surface particle cleanliness

BS 5295

In the UK, British Standard 5295 has been withdrawn and has been superseded by the ISO 14644 family of standards.

The guidance given in the EU GMP (The rules governing medicinal products in the European Union. Volume 4. Good manufacturing practices – Medicinal products for human and veterinary use) corresponds approximately to the BS EN ISO 14644 classifications.