The importance of cleanroom validation

Cleanroom validation offers ISO compliance and peace of mind

When a cleanroom has been built by Connect 2 Cleanrooms, a CTCB-I qualified engineer completes a validation to International Standard ISO 14644-1:2015.

Ongoing validations are not only a requirement of this standard, they also give peace of mind that your investment remains protected and continues to add value to your company and critical processes.

Following install, cleanrooms are typically validated to the ‘as built’ occupancy state according to the agreed ISO 14644-1:2015 cleanroom classification.

A comprehensive cleanroom validation report will be supplied within 2 weeks of installation detailing our agreed scope of works.

Validation Scope

We offer customer choice to provide a balance to ISO standards and own risk assessment and monitoring plan. Tests to consider include:

  • Filter integrity testing according to ISO 14644-3:2005
  • Airborne particle counts
  • Airflow readings
  • Air changes and volumes
  • Smoke visualisation testing according to ISO 14644-3:2005
  • Containment leak testing according to ISO 14644-3:2005
  • Recovery rate testing according to ISO 14644-3:2005
  • Air pressure differentials according to 14644-1:2015
  • Comfort tests such as lux, noise levels, temperature and RH readings
  • Particle Counter Calibration certificates to prove instrumentation complies to ISO 21501-4:2007
  • Safety cabinet testing including KI Discuss testing & Fume Cabinet Testing including Carbon Breakthrough Testing to BS7989

The format of the report is in line with the ISO standards, so should meet your requirements and those of any nominated regulatory body.

Validation Frequency Requirements

To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be validated at process-dependent intervals to prove it complies with ISO 14644-1:2015 - Classification of air cleanliness by particle concentration.

ISO 14644-2:2015 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual processes.

It states the suggested maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months and ISO class 6 and above is 12 months. However this should be assessed to ensure it is in-line with your monitoring plan and risk assessment, which is required to be reviewed on a regular basis.