Cleanroom Qualification - ISO14644

Quality Solutions, LLC testing protocols include qualification of supporting utilities and equipment such as air handlers, building monitoring systems, air, and water systems.   

Cleanroom certification typically consists of:
  • HEPA filter leak testing
  • Airflow velocity and volume testing
  • Room differential pressure testing
  • Visual airflow characterization
  • Room temperature and humidity testing
  • Viable surface and air sampling
  • Non-Viable air sampling
  • Ambient light and noise levels
Quality Solutions, LLC manages the analysis of room data, provides viable plate enumeration, and coordinates the microbiological identification of bacterial and fungal organisms.  

Once room certification takes place, we can prvide on-going routine monitoring services needed to maintain compliance as part of a complete environmental monitoring program.  We can provide support for the development of Cleanroom procedures, alert and action limits, training programs, media fill testing, and ongoing environmental testing. 

 
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