ISO 14644-1 Class 5 Cleanroom Classification guidelines
Information on ISO 14644-1:2015 class 5 Cleanroom Classification.
- Federal Standard 209E equivalent: Class 100 Cleanroom
- Associated EU GMP Grade: A/B
- Recommended air changes per hour (ACH): 240-480
- For ISO 5 cleanrooms, organisations typically measure micron sizes 0.5µ and 0.3µ, with GMP A/B also looking at 5.0µ.
- See the maximum allowable concentrations by cleanroom class on our cleanroom classifications page.
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.
Considerations for ISO Class 5 Cleanrooms
As ISO Class 5 cleanrooms are at the more critical end of the class spectrum, they require a greater level of filtration to achieve the level of cleanliness.
Ultra Low Penetration Air (ULPA) Filtration is 99.9995% efficient at 0.12 micron and should be considered when looking to achieve ISO class 5.
Hardwall and monobloc cleanroom constructions are most effective at achieving the environment required for ISO class 5. Often it will only be a specific part of a process that requires ISO Class 5 control. Fan filter units delivering laminar airflow over integrated benching is an effective way of achieving particulate control that meets ISO Class 5 requirements.
If organisations are required to meet GMP grades then monobloc is the most effective solution, as it can accommodate required features such as interlocked doors and coved floors.
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