Commissioning & Validation

Commissioning & Validation

CDC Cleanroom Specialists offers a comprehensive range of services from standard mechanical and electrical testing and commissioning, to specialist validation for ISO and EU GMP facilities.

Having decades of experience in the testing and validation of critical and non-critical facilities to ISO 14644, GMP and HTM standards, we provide you with a comprehensive service and report, ensuring your facilities are audit ready and compliant with the requirements of regulatory bodies. 

We offer

  • Airflow measurement – volume and velocity
  • Airflow Quality Particle Counts (ISO 14644-1)
  • Airflow direction and visualisation
  • Air Change Rates
  • Microbial airborne and surface contamination
  • H.E.P.A. filter installation leak tests (ISO 14644-3)
  • Room Pressure Differentials
  • Room Light Levels
  • Room Temperature and Humidity Levels
  • Room Fabric Integrity
  • Magnehelic Gauge Calibration

 

Simply get in touch for a FREE consultation on which servicing and maintenance package would work best for you!

Guide for frequency of cleanroom validity

Required test

Classification

Maximum time interval

Test procedure

Particle count

<= ISO Class 5

6 months

ISO 14644-1:2015

>ISO class 6

12 months

ISO 14644-1:2015

Air pressure

All ISO classes

12 months

ISO 14644-3:2015

Airflow

All ISO classes

12 months

ISO 14644-2:2015

Filter integrity

All ISO classes

24 months

ISO 14644-3:2005

Containment leak

All ISO classes

24 months

ISO 14644-3:2005

Recovery

All ISO classes

24 months

ISO 14644-3:2005

Airflow visualisation

All ISO classes

24 months

ISO 14644-3:2005

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