Comparing Cleanroom Standards to ISO ISO14644
Why are cleanroom standards needed?
Cleanroom standards provide a language or framework for labelling cleanrooms. This is important for a number of reasons including:
- Ensure consistency and uniformity.
- Maintain quality control.
- Meet regulatory compliance.
- Reduce risk management.
- Provide benchmarking.
- Allow interoperability.
- Build customer assurance.
- Enhance operational efficiency.
- Encourage innovation and development.
Different Standards
The importance of cleanroom standards is well understood and over the years, a number of different standards were developed including ISO14644-1, FED 209, and GMP.
It is important to be able to compare these standards and to understand how the classifications in each of these standards relate to one another. In particular the allowed particle size for a selected category is a key attribute for cleanrooms.
Example: Class 1000 cleanroom iso equivalent
The classification ‘Class 1000’ refers to the FED209 standard which was published in 1961 but was withdrawn in 2001 in favor of ISO14644. While this standard may not be in widespread use, it is still referred to and many cleanrooms were categorized against the FED209 standard in the past.
Tables like that shown in this article provide a direct comparison between these standards. You will notice from the table that the ISO equivalent of a class 1000 cleanroom is ISO Class 6 or Grade B in the EU GMP Classification. This classification places a restriction on the number of allowed particles allowed in each size band per cubic meter as shown in the table.
This table can be used in a similar way for each of the other classifications. More information is available on the Cleanroom Classification page.
