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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.

Due to the robust design and engineering we offer a 5 year guarantee on our cleanrooms, so you have peace of mind that your investment remains protected and continues to add value to your company and critical processes.

Our modular cleanrooms at Connect 2 Cleanrooms can be manufactured to achieve between ISO Class 5 to ISO Class 9.

The cleanrooms will be 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.

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

  • Filter integrity testing
  • Smoke visualisation testing
  • Containment leak testing
  • Recovery Rate testing
  • Air pressure differentials
  • Comfort tests such as lux and noise levels and recording temperature and RH
  • Particle Counter Calibration certificates to prove instrumentation complies to ISO 21501-4:2007 - Does your current equipment comply?

The format of the report is in line with the current ISO standards and will meet your requirements to show compliance and keep an ongoing record of your testing for auditing purposes.

Validation Frequency Requirements

To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be validated regularly 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.  Does your current system or process allow for the above? Does

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 to be reviewed on a regular basis.

Test Parameter Class Maximum Time Interval
Airborne particle concentrations
& filter integrity testing
≤ ISO Class 5
> ISO Class 5
6 months
12 months
Schedule of additional tests
Airflow velocities in unidirectional airflow
Airflow volume supply in non-unidirectional
airflow
Pressure differentials

All classes
All classes

All classes

6 months
12 months

Continuously monitored

Cleanroom Service Contracts

If you have a Connect 2 Cleanrooms room, we strongly advise you to have a regular validation service performed by one of our CTCB qualified Project Engineers, as we understand the workings of your cleanroom and we believe we should remain your company of choice. This is your guarantee that the cleanroom solution you have invested in will remain protected.

To discuss your annual Connect 2 Cleanrooms validation service contract or your current monitoring plan and risk assessment, call +44 (0)1524 813020 or email helen@connect2cleanrooms.com.

What happens next? Read about our cleanroom training or consumables & equipment division, Cleanroom Standards or DOP Testing

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