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22nd Oct 2015

Why Do I Need to Validate my Cleanroom?

Regular cleanroom validation can help detect and identify any harmful contamination sources, as well as assuring regulatory bodies and clients that your environment continues to meet its ISO Class parameters.  In short, it ensures your critical process remains protected.

If a cleanroom does not have a current validation certificate to prove it meets the particle concentration limits set out in ISO 14644-1 then it will not be compliant to ISO 14644-2.

ISO Cleanroom Standard Explained

ISO 14644 is the international standard for cleanrooms and associated controlled environments.  
Part 2 of this standard (ISO 14644-2) covers specifications for testing and monitoring to prove continued compliance with ISO 14644-1. It sets regular intervals for testing to demonstrate compliance with particle concentration limits, shown in the table below.

  Classification   Maximum time interval
  ISO Class 5 and lower   6 months
  Above ISO Class 5    12 months

If your cleanroom is not covered by a current and accurate validation report, this could have significant consequences to your business.  

Benefits at a glance 

  • Assurance of ISO class - protects your investment, giving peace of mind!
  • Pre-filter change - prolongs HEPA/ULPA filter life 
  • Offers complete cleanroom confidence - adding value to your product production!
  • Raw data available & full report provided for your customer audits.
  • We offer expert advice on cleanroom efficiency - including cleaning, clothing & furniture.

Validation service 

  • Full cleanroom validation includes – airborne particle counts, airflow measurement, air changes & pre-filter change.
  • Additional services include – lighting lux levels, sound levels, filter integrity test (smoke challenge).
  • For more details visit our cleanroom validation page.

Filter Integrity Testing  

If your HEPA or ULPA filter is not working efficiently you run the risk of contamination entering your cleanroom, potentially impacting your process and product quality. 

Filter integrity testing is the process in which the integrity of your HEPA (High Efficiency Particulate Air) or ULPA (Ultra Low Penetration Air) filter is tested through the introduction of particulates. 

Oil is dispersed as an aerosol into the upstream flow of the filter media while the number of particles in the downstream flow is measured using a calibrated photometer.

Interested in a validation or filter integrity testing quote?  

Call us today on 01524 813020, email us or join us on live chat.

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