Recommended Cleanroom Validation Frequency to Meet ISO 14644-1:2015

Recommended Cleanroom Validation Frequency to Meet ISO 14644-1:2015

ISO 14644-1:2015 classifies air cleanliness for airborne particle population levels (ranging from 0,1 µm to 5 µm, lower-limit threshold) in cleanrooms and clean zones; and separative devices – in addition to those defined in ISO 14644‑7.

How often a cleanroom be validated to meet ISO 14644-1:2015?

ISO 14644-1:2015 states the maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is six months and ISO class 6 and above is 12 months.

Test Parameter Class Maximum Time Interval
Airborne particle concentrations = ISO Class 5 6 months
>ISO Class 5 12 months
Schedule of additional tests
Airflow velocities in unidirectional airflow All classes> 6 months
Airflow volume supply in non-unidirectional airflow All classes 12 months
Pressure differentials All classes Continuously monitored

Source: cleanroomtechnology.com

Highlights of ISO 14644-1:2015:

  • In ISO 14644-1:2015, particle populations ranging from 0,1 µm to 5 µm (less than the lower-limit threshold) are considered for classification purposes.
  • Classification is not provided for particle populations outside of the particle population range of lower threshold particle-size range, 0,1 µm to 5 µm.
  • Light scattering airborne particle counters (LSAPC) are used to identify and count airborne particles that fall within the outlined size threshold in this chapter.
  • ISO 14644-1:2015 does not classify molecule populaces that are outside the predefined lower limit molecule size reach, 0,1 µm to 5 µm. Convergences of ultrafine (particles littler than 0,1 µm) will be tended to in a different standard to determine air cleanliness by nano-scale particles. A M descriptor (see Annex C) might be utilized to measure populaces of macroparticles (particles bigger than 5 µm).
  • Chemical, physical, radiological, viable or identifying features of airborne particle are not characterized in ISO 14644-1:2015
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