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18th Jan 2017

The Importance of Validating your Cleanroom

Regular cleanroom validation can help detect and identify any harmful contamination sources, as well as assuring regulatory bodies and clients that your controlled 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 14644-1:2015 then it will not be compliant to ISO 14644-2:2015.

What is the risk to your business if you don’t regularly validate your Cleanroom?

Although guidance is in place for validating your controlled environment, the scope and frequency of your validations should be defined by your businesses individual risk assessment.  Intervals should be assigned in-line with each risk identified.  Failure to do so could result in high maintenance costs and loss of operational time.

How often should you validate your cleanroom?

To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be validated 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.

The above standard states the 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.

Benefits of using Connect 2 Cleanrooms Validation Service:

  • Save both time and money – Keep both costs and loss of operational time to a minimum, protecting your investment
  • A brand you can trust – Validations are performed by our CTCB qualified Project Engineers, providing you with peace of mind
  • Traceable validation and maintenance records for auditing purposes
  • Free validation reminder service based on your requirements as part of a long term validation package
  • We offer expert advice on cleanroom efficiency - including cleaning, clothing & furniture.

Cleanroom Validation Service 

We strongly advise you to have a regular validation service performed by one of our CTCB qualified Project Engineers, as we know your cleanroom. This is your guarantee that the cleanroom solution you have invested in will carry on working for you.
  • Full cleanroom validation includes – airborne particle counts, airflow measurement, air changes & pre-filter change.
  • Additional services include – filter integrity test (smoke challenge), smoke visualisation testing, containment leak testing, recovery rate testing, air pressure differential, lighting lux levels & sound levels and particle counter calibration
For more details visit our cleanroom validation page

Filter integrity testing

Filter integrity and efficiency is vital.  If the filter is not working efficiently you run the risk of contamination entering your cleanroom, potentially impacting on your processes and product quality and, in turn, affecting your cleanroom classification.

Equipment using a HEPA or ULPA filter should be tested every time the equipment is moved to ensure no damage due to transportation has occurred and at regular intervals.

If your filter is not working efficiently you run the risk of contamination entering your cleanroom, potentially impacting on your processes and product quality and, in turn, affecting your cleanrooms classification. A DOP test can therefore reduce costly product recalls, saving money, time and preventing damage to your brand.

Call our After Sales Coordinator, Helen Tebay, today on +44 (0)1524 813020 to discuss your validation and testing requirements or email helen@connect2cleanrooms.com.

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