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GMP News
17/11/2010

Important revision of ISO 14644-1: Clean Room Classification is likely to

be changed

ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness
classification standard for the last 4 years. The ISO community voted in favour of revision to update and
improve the standard specifically to address the following:

 Simplify the classification process, and if possible remove the need to evaluate the 95% UCL for
2-9 sample locations
 Review the classification procedure and make it more applicable to rooms in operation. In this
situation, the contamination isn't expected to be evenly distributed, an assumption the current
statistical approach makes
 Generally update the standard as required to current thinking and industry requirements
 Avoid any radical change to the principles of the current ISO cleanliness classes 1-9

So, this was the challenge, and now we have the first public airing of the proposals. The DIS (draft
International Standard) should be published for public comment and national vote in December 2010.
The revised standard has some important new and revised requirements. These are summarised below:

 The classification would be based on a table (see fig.1.), with the well known formula used for the
intermediate decimal classes (see fig.2.). In the current standard, the table is provided in an
informative annex (see fig.3.). By using a look-up table as the basis for classification, it is easier
to constrain the reader to appropriate particle sizes for specific classes

Fig.1 The basic classification table proposed in ISO DIS 14644-1:2010

Table 1 Selected airborne particulate cleanliness classes

Maximum concentration limits (particles/m3)
ISO Classification Number (N)
0.1 m 0.2 m 0.3 m 0.5 m 1.0 m 5.0 m
ISO Class 1 10
ISO Class 2 100 24 10
ISO Class 3 1 000 237 102 35
ISO Class 4 10 000 2 370 1 020 352 83
ISO Class 5 100 000 23 700 10 200 3 520 832
ISO Class 6 1 000 000 237 000 102 000 35 200 8 320 298
ISO Class 7 352 000 83 200 2 930
ISO Class 8 3 520 000 832 000 29 300
ISO Class 9 35 200 000 8 320 000 293 000

Fig.2 The formula proposed for intermediate decimal classes in ISO DIS 14644-1:2010

Fig.3 The informative classification table provided in ISO 14644-1:1999

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Table 1 Selected airborne particulate cleanliness classes

Maximum concentration limits (particles/m3)
ISO Classification Number (N)
0.1 m 0.2 m 0.3 m 0.5 m 1.0 m 5.0 m
ISO Class 1 10 2
ISO Class 2 100 24 10 4
ISO Class 3 1 000 237 102 35 8
ISO Class 4 10 000 2 370 1 020 352 83
ISO Class 5 100 000 23 700 10 200 3 520 832 29
ISO Class 6 1 000 000 237 000 102 000 35 200 8 320 298
ISO Class 7 352 000 83 200 2 930
ISO Class 8 3 520 000 832 000 29 300
ISO Class 9 35 200 000 8 320 000 293 000

The selection of number of sample locations has been based on a more rational basis intended to
confirm with 95% confidence that 90% of the cleanroom will meet the intended classification (see fig.4.) .
Also shown is the difference between the number of old and new sample locations

Fig.4 The table proposed for determining the number of sample locations in ISO DIS 14644-1:2010

Old number of sample min number new sample

Area of zone [m2]
locations locations
2 2 1
4 2 2
6 3 3
8 3 4
10 4 5
24 5 6
28 6 7
32 6 8
36 6 9
52 8 10
56 8 11
64 8 12
68 9 13
72 9 14
76 9 15
104 11 16
108 11 17
116 11 18
148 13 19
156 13 20
192 14 21
232 16 22
276 17 23
352 19 24
436 21 25
500 24 26

 A semi-random sampling technique is proposed based on a "hypergeometric" distribution, which

is the statistical model for sampling without replacement. This is a significant change from current
practice, and means that each time a zone is classified, the sample locations may be different. If
a firm has determined through a risk assessment, that certain locations need to be examined
specifically, then these should be designated in addition to the randomly selected locations
 Recognising that the <=5.0 micron class limit for ISO 5 has been removed in the revised
standard, parties wishing to use the standard for classifying the environments EU GMP Grade A,

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and B "at rest" will have to use the macro-particle descriptor retained in the standard

Author:
Gordon Farquharson
Convenor ISO TC209 WG1
Critical Systems Ltd.,
Guildford, Surrey, UK, GU1 2SY

http://www.gmp-compliance.org/pa4.cgi?src=eca_new_news_print_data.htm&nr=2257 05/01/2011