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ISO 14644-1 Class 8 Cleanroom Classification Guidelines

Information on ISO 14644-1:2015 class 8 Cleanroom Classification.

  • Federal Standard 209E equivalent: Class 100,000
  • Associated EU GMP Grade: D
  • Recommended air changes per hour (ACH): 5-48
  • Typically measured micron sizes: 5.0µ and 0.5µ.
  • Maximum allowable concentrations by cleanroom class: See our cleanroom classifications page
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ISO Class Cleanroom

ISO 14644-1 requirements describe contamination levels in terms of allowed air particulates in number and size. IEST Technical Guides serve as complementary documents to ISO Standards ISO 14644. They give guidance on recommended air change rates or airflow speed within the cleanroom.

ISO class 8 cleanroom info

Considerations for ISO class 8 cleanrooms

High Efficiency Particulate Air (HEPA) Filtration is 99.99% efficient at 0.3 micron and should be considered when looking to achieve ISO class 8.

Monobloc panel, hardwall and softwall cleanroom envelopes are all effective at achieving the environment required for ISO class 8.

If organisations are working towards GMP grades, monobloc is the most effective solution, as it can accommodate required features such as interlocked doors and coved floors.

 

CUSTOM BUILT ISO CLEANROOMS

 

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