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NEWS
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Equipment
Elements of cleanrooms:
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Pharmacy
Since 2000 Miass Factory of Medical Equipment has carried out designing and construction of complexes of cleanrooms for different fields of industries. As the base for this direction of activity 15-years-old experience of our factory in creation of cleanrooms for medical units serves...
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Classification of cleanrooms
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| АМС МЗМО/English Version/Production/Pharmacy/Classification of cleanrooms
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Classification of cleanrooms manufacturing of pharmacy according to OST 42-510-98
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Cleanliness class of premises or zones
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Maximum admissible quantity of particles in 1 m3 of air in size, micron
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Maximum admissible quantity of viable microorganisms in 1 m3 of air
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> 5
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> 0,5
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> 5
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Fitted mode 2)
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Functioning mode
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A
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3500
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0
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3500
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0
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Less than 1
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В 1)
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3500
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0
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350000
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2000
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10
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С 1)
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350000
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2000
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3500000
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20000
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100 4)
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D 1)
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3500000
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20000
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Not defined 3)
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200-500 4), 5)
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Notes:
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For zones or premises with cleanliness classes A, B and C the system of air supplying should have corresponding filters, for example HEPA filters. For achievement cleanliness classes B, C and D the frequency rate of air exchange, considering the size of premise, equipment and personnel being in it is necessary.
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Values of maximum admissible number of particles in the equipped mode approximately correspond to classifications by Federal Standard of the USA 209 E, standards ISO, Gost R 50766-95 and RD 64-125-91 as follows:
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А and В - class 100; М 3,5 ISО 5; R5 (100); 1 (in RD 64-125-91 class В was absent).
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С - class 10000; М 5,5 ISO 7; R7(10000); 2.
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D - class 100000; М 6,5 ISO 8; R8(100000); 3. .
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Requirements and norms depend on type of manufactured goods and the character of carried out operations.
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Manufacture of unsterile pharmacies should be carried out in premises with cleanliness classes C and D. Rationing of the maintenance of viable microorganisms in air is provided. Rationing of the maintenance of mechanical substances usually isn’t provided.
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In premises of cleanliness class D manufacturing of sterile pharmacies is supposed no more than 200 viable microorganisms per 1 m3 of air, in premises with cleanliness classes D manufacturing of unsterile pharmacies – no more than 500 ones.
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