Domestic standards and international industry norms of clean room industry_Industry norms_News_sz-pharma

Cleanrooms are classified according to the number of particles in the air. This metric term is also accepted in China using the latest 209E version of the standard. The new standard is TC 209 of the International Standards Organization. Both standards classify cleanrooms based on the number of particles found in the pharma machinery air. classification standards FS 209E and ISO 14644. -1 requires specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms. This standard is about to be superseded by BS EN ISO 14644-1. Cleanrooms are classified according to the number and size of particles allowed in each volume of air. Large numbers like '100' or '1000' refer to FED_STD-209E and indicate the number of particles 0.5 mm or larger allowed per cubic foot of air. The standard also allows interpolation, so for example 'level 2000' can be described. Decimals refer to the ISO 14644-1 standard, which specifies the decimal logarithm of the number of particles 0.1 microns or larger allowed per cubic meter of air. So, for example, an ISO class 5 clean room has a maximum of 105 = 100,000 particles per cubic meter. Both FS 209E and ISO 14644-1 assume a logarithmic relationship between particle size and particle concentration. Therefore, there is no such thing as zero particle concentration. Normal room air is about one million class or ISO 9. Before the International Standards Organization (ISO) adopted global cleanroom classifications and standards, the United States. The General Services Administration's standard, known as FS209E, applies almost globally. However, as the demand for international standards increased, ISO established a technical committee and several working groups to delineate its own set of standards. FS209E contains six categories, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard. The FS209E's 'cleanest' cleanroom is called class 1; the 'dirtiest' pharma clean room is class 100,000. ISO pharma clean room classifications are rated based on how many particles of a specific size are present per cubic meter. The 'cleanest' clean room is a class 1, and the 'dirtiest' is a class 9. ISO Class 3 is approximately equal to FS209E Class 1, while ISO Class 8 is approximately equal to FS209E Class 100,000.
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