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    This document compares cleanroom classification standards from various international organizations including the Federal Standard 209E, British Standard 5295, EU GMP, and ISO 14644-1. It provides a table that lists the maximum permitted number of particles of various sizes for each cleanroom classification according to the different standards. The table shows that while there are many similarities between standards, there are also some differences in how they classify cleanrooms and define acceptable particle levels.

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    Clean room classification chart.

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    This document compares cleanroom classification standards from various international organizations including the Federal Standard 209E, British Standard 5295, EU GMP, and ISO 14644-1. It provides a table that lists the maximum permitted number of particles of various sizes for each cleanroom classification according to the different standards. The table shows that while there are many similarities between standards, there are also some differences in how they classify cleanrooms and define acceptable particle levels.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    Download as pdf or txt
    101 views1 page

    Clean Room-Classifications Chart

    Uploaded by

    raju1559405
    This document compares cleanroom classification standards from various international organizations including the Federal Standard 209E, British Standard 5295, EU GMP, and ISO 14644-1. It provides a table that lists the maximum permitted number of particles of various sizes for each cleanroom classification according to the different standards. The table shows that while there are many similarities between standards, there are also some differences in how they classify cleanrooms and define acceptable particle levels.

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    © All Rights Reserved
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    of 1

    Validation in Partnership

    Classification of Cleanrooms - Comparison of International Standards


    Standard and Date Published
    Fed.Std.

    Fed.Std.

    209D

    209E

    (1988) *

    (1992) *

    B.S.5295
    (1989) *

    Maximum permitted number of particles (equal to, or greater than, stated size) at rest

    EU

    EN ISO

    CGMP

    14644-1

    (1998)

    (1999)

    0.1 m

    0.2 m

    0.3 m

    0.5 m

    1 m

    5 m

    10 m

    25 m

    NS

    ISO 1

    10/m

    NS

    NS

    NS

    NS

    ISO 2

    100/m

    24/m

    10/m

    4/m

    NS

    NS

    NS

    NS

    350/m3
    9.91/ft3

    75.7/m3
    2.14/ft3

    30.9/m3
    0.875/ft3

    10.0/m3
    0.283/ft3

    NS

    NS

    NS

    NS

    35/ft3

    7.5/ft3

    3/ft3

    1/ft3

    NS

    NS

    NS

    NS

    1,240/m3
    35/ft3

    265/m3
    7.5/ft3

    106/m3
    3/ft3

    35.3/m3
    1/ft3

    NS

    NS

    NS

    NS

    NS

    NS

    100/m

    35/m

    NS

    0/m

    NS

    NS

    1,000/m3

    237/m3

    102/m3

    35/m3

    8/m3

    NS

    NS

    NS

    3,500/m3
    99.1/ft3

    757/m3
    21.4/ft3

    309/m3
    8.75/ft3

    100/m3
    2.83/ft3

    NS

    NS

    NS

    NS

    NS

    NS

    NS
    NS

    M1
    1
    M1.5
    C
    ISO 3
    M2

    3
    3

    10
    M2.5
    D
    ISO 4
    M3
    100

    2/m

    NS

    E
    F
    A
    B
    ISO 5

    1,000

    350/ft

    75/ft

    30/ft

    10/ft

    NS

    12,400/m3
    350/ft3

    2,650/m3
    75/ft3

    1,060/m3
    30/ft3

    353/m3
    10/ft3

    NS

    NS

    NS

    NS

    NS

    1,000/m3

    350/m3

    NS

    0/m3

    NS

    NS

    10,000/m3

    2,370/m3

    1,020/m3

    352/m3

    83/m3

    NS

    NS

    NS

    35,000/m3
    991/ft3

    7,570/m3
    214/ft3

    3,090/m3
    87.5/ft3

    1,000/m3
    28.3/ft3

    NS

    NS

    NS

    NS

    NS

    NS

    NS

    NS

    NS

    750/ft

    NS

    26,500/m
    750/ft3

    10,600/m
    300/ft3

    300/ft

    3,530/m
    100/ft3

    NS

    NS

    NS

    NS

    NS

    NS

    10,000/m3

    3,500/m3

    NS

    0/m3

    NS

    NS

    NS

    NS

    NS

    3,500/m3

    NS

    0/m3

    NS

    NS

    NS

    NS

    NS

    3,500/m

    NS

    1/m

    NS

    NS

    NS

    NS

    NS

    3,500/m3

    NS

    1/m3

    NS

    NS

    100,000/m3

    23,700/m3

    10,200/m3

    3,520/m3

    832/m3

    29/m3

    NA

    NA

    75,700/m
    2,140/ft3

    NS

    30,900/m
    875/ft3

    10,000/m
    283/ft3

    NS

    NS

    NS

    NS

    NS

    NS

    NS

    1,000/ft3

    NS

    7/ft3

    NS

    NS

    NS

    NS

    0/m3

    NS

    M4

    M3.5

    100/ft
    3

    NS

    NS

    NS

    35,300/m
    1,000/ft3

    NS

    247/m
    7/ft3

    NS

    NS

    100,000/m3

    35,000/m3

    NS

    200/m3

    NS

    NS

    NS

    35,000/m

    NS

    200/m

    0/m

    NS

    1,000,000/m3

    237,000/m3

    102,000/m3

    35,200/m3

    8,320/m3

    293/m3

    NS

    NS

    NS

    NS

    NS

    100,000/m
    2,830/ft3

    NS

    618/m3
    17.5/ft3

    NS

    NS

    NS

    NS

    M4.5

    ISO 6

    M5
    10,000

    NS

    NS

    NS

    10,000/ft

    NS

    NS

    NS

    353,000/m
    10,000/ft3

    NS

    70/ft

    NS

    2,470/m
    70/ft3

    M5.5
    J
    C
    ISO 7
    M6
    100,000

    K
    D
    ISO 8

    ISO 9
    L
    M
    NS denotes Not Specified
    * denotes Superseded

    NS

    NS

    NS

    350,000/m

    NS

    2,000/m

    450/m

    0/m3

    NS

    NS

    NS

    350,000/m3

    NS

    2,000/m3

    NS

    NS

    NS

    NS

    NS

    352,000/m3

    83,200/m3

    2,930/m3

    NS

    NS

    NS

    NS

    NS

    1,000,000/m3
    28,300/ft3

    NS

    6,180/m3
    175/ft3

    NS

    NS

    NS

    NS

    NS

    NS

    100,000/ft

    NS

    NS

    NS

    3,530,000/m3
    100,000/ft3

    NS

    NS

    NS

    3,500,000/m

    NS

    700/ft

    NS

    24,700/m3
    700/ft3

    NS

    20,000/m

    NS
    4,500/m

    500/m

    NS

    NS

    NS

    NS
    NS

    NS

    832,000/m

    29,300/m

    NS

    NS

    NS

    NS

    3,500,000/m

    NS

    NS

    NS

    3,520,000/m

    20,000/m
    3

    NS

    M7

    NS

    NS

    NS

    M6.5

    NS

    NS

    NS

    10,000,000/m
    283,000/ft3

    NS

    61,800/m
    1,750/ft3

    NS

    NS

    NS

    35,200,000/m3

    8,320,000/m3

    293,000/m3

    NS

    NS

    NS

    NS

    NS

    NS

    NS

    200,000/m3

    45,000/m3

    5,000/m3

    NS

    NS

    NS

    NS

    NS

    NS

    450,000/m3

    50,000/m3

    Validation in Partnership Ltd.


    Adelphi Mill, Grimshaw Lane, Bollington, Cheshire, UK, SK10 5JB

    Tel.: +44 (0) 1625 572777

    Fax: +44 (0) 1625 573777

    Email: Info@ViPLtd.co.uk

    Web: www.ViPLtd.co.uk

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