Clean Room Classification in Medical Device|Clean Room in Manufacturing|Clean Room Standards| IVD

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Clean Room Classification in Medical Device|Clean Room in Manufacturing|Clean Room Standards| IVD @ivdmanufacturing7208

Clean Room : Room within which the number concentration of airborne particles is controlled and classified and which is designed constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.
Clean Zone : A defined space within which the number concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation and retention of contaminants inside the space.
Occupancy State – as built, at rest and at operational.
Particle Size -
ISO Class Number

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like “class 100” or “class 1000” refer to FED_STD-209E, and denote the number of particles of size 0.5 mm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. “class 2000.”

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per cubic meter of air. So, for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per m3.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration. Ordinary room air is approximately class 1,000,000 or ISO 9.

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 applied virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.

FS209E contains six classes, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard (see chart below). The "cleanest" cleanroom in FS209E is referred to as Class 1; the "dirtiest" cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1 and the "dirtiest" a class 9. ISO class 3 is approximately equal to FS209E class 1, while ISO class 8 approximately equals FS209E class 100,000.

By law, Federal Standard 209E can be superseded by new international standards. It is expected that 209E will be used in some industries over the next five years, but that eventually it will be replaced internationally by ISO 14644-1.


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