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ISO Cleanroom Standards and Classification

Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration's standards (known as FS209E) were widely accepted worldwide. However, with the increasing demand for international standards, the ISO established a technical committee and multiple working groups to develop its own set of standards.


FS209E includes six classes. In contrast, the ISO 14644-1 classification system introduces two cleaner standards and one less clean standard (refer to the chart below). The cleanest cleanroom in FS209E is designated as Class 1, whereas the least clean is Class 100,000.


ISO cleanroom classifications are based on the concentration of particulates of specific sizes per cubic meter (refer to the second chart). The cleanest ISO cleanroom is Class 1, and the least clean is Class 9. ISO Class 3 is roughly equivalent to FS209E Class 1, while ISO Class 8 is comparable to FS209E Class 100,000.


Softwall Clean Rooms

Softwall clean rooms are specialized enclosures used in industries requiring controlled atmospheres, such as biotechnology, medical testing, and semiconductor fabrication. Unlike hard wall clean rooms, which are more stationary, softwall clean rooms offer several distinctive features.


The walls of softwall clean rooms can be constructed from materials like taut fabric stretched over a frame or translucent plastic strips suspended from an overhead fixture. This design allows for flexibility and ease of installation in various locations. Unlike hard wall clean rooms that are typically fixed once installed, softwall clean rooms are highly portable. Some versions are modular, enabling quick disassembly and reassembly as needed.


These characteristics make softwall clean rooms ideal for environments where flexibility, mobility, and temporary installations are advantageous, while still maintaining the necessary controlled environment for sensitive processes and testing procedures.


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Contact us today and one of our cleanroom experts will discuss the best path forwards for your project.





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