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Classification of Cleanrooms

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Maximum permitted number of particles (equal to, or greater than, stated size) at rest' ... denotes Superseded. Validation in Partnership Ltd. ... – PowerPoint PPT presentation

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Title: Classification of Cleanrooms


1
Validation in Partnership
Classification of
Cleanrooms - Comparison of International
Standards
Standard and Date Published
Maximum permitted number of particles (equal to,
or greater than, stated size) at rest
Fed.Std.
Fed.Std.
B.S.5295
EU
EN ISO
209D
209E
(1989)
CGMP
14644-1
m
m
m
m
m
m
m
m
0.1
m
0.2
m
0.3
m
0.5
m
1
m
5
m
10
m
25
m
(1988)
(1992)
(1998)
(1999)
ISO 1
3
3
10/m
2/m
NS
NS
NS
NS
NS
NS
ISO 2
3
3
3
3
100/m
24/m
10/m
4/m
NS
NS
NS
NS
3
3
3
3
350/m
75.7/m
30.9/m
10.0/m
M1
NS
NS
NS
NS
9.91/ft
3
2.14/ft
3
0.875/ft
3
0.283/ft
3
3
3
3
3
1
35/ft
7.5/ft
3/ft
1/ft
NS
NS
NS
NS
3
3
3
3
1,240/m
265/m
106/m
35.3/m
M1.5
NS
NS
NS
NS
35/ft
3
7.5/ft
3
3/ft
3
1/ft
3
C
3
3
3
NS
NS
100/m
35/m
NS
0/m
NS
NS
ISO 3
3
3
3
3
3
1,000/m
237/m
102/m
35/m
8/m
NS
NS
NS
3
3
3
3
3,500/m
757/m
309/m
100/m
M2
NS
NS
NS
NS
99.1/ft
3
21.4/ft
3
8.75/ft
3
2.83/ft
3
10
3
3
3
3
350/ft
75/ft
30/ft
10/ft
NS
NS
NS
NS
3
3
3
3
12,400/m
2,650/m
1,060/m
353/m
M2.5
NS
NS
NS
NS
3
3
3
3
350/ft
75/ft
30/ft
10/ft
D
3
3
3
NS
NS
1,000/m
350/m
NS
0/m
NS
NS
ISO 4
3
3
3
3
3
10,000/m
2,370/m
1,020/m
352/m
83/m
NS
NS
NS
3
3
3
3
35,000/m
7,570/m
3,090/m
1,000/m
M3
NS
NS
NS
NS
991/ft
3
214/ft
3
87.5/ft
3
28.3/ft
3
100
3
3
3
NS
750/ft
300/ft
100/ft
NS
NS
NS
NS
3
3
3
26,500/m
10,600/m
3,530/m
M3.5
NS
NS
NS
NS
NS
750/ft
3
300/ft
3
100/ft
3
E
3
3
3
NS
NS
10,000/m
3,500/m
NS
0/m
NS
NS
F
3
3
NS
NS
NS
3,500/m
NS
0/m
NS
NS
A
3
3
NS
NS
NS
3,500/m
NS
1/m
NS
NS
B
3
3
NS
NS
NS
3,500/m
NS
1/m
NS
NS
ISO 5
3
3
3
3
3
3
100,000/m
23,700/m
10,200/m
3,520/m
832/m
29/m
NA
NA
3
3
3
75,700/m
30,900/m
10,000/m
M4
NS
NS
NS
NS
NS
3
3
3
2,140/ft
875/ft
283/ft
1,000
3
3
NS
NS
NS
1,000/ft
NS
7/ft
NS
NS
3
3
35,300/m
247/m
M4.5
NS
NS
NS
NS
NS
NS
1,000/ft
3
7/ft
3
G
3
3
3
3
NS
NS
100,000/m
35,000/m
NS
200/m
0/m
NS
H
3
3
3
NS
NS
NS
35,000/m
NS
200/m
0/m
NS
ISO 6
3
3
3
3
3
3
1,000,000/m
237,000/m
102,000/m
35,200/m
8,320/m
293/m
NS
NS
3
3
100,000/m
618/m
M5
NS
NS
NS
NS
NS
NS
2,830/ft
17.5/ft
3
3
3
3
10,000
NS
NS
NS
10,000/ft
NS
70/ft
NS
NS
3
3
353,000/m
2,470/m
M5.5
NS
NS
NS
NS
NS
NS
10,000/ft
3
70/ft
3
J
3
3
3
3
NS
NS
NS
350,000/m
NS
2,000/m
450/m
0/m
C
3
3
NS
NS
NS
350,000/m
NS
2,000/m
NS
NS
ISO 7
352,000/m
3
83,200/m
3
2,930/m
3
NS
NS
NS
NS
NS
3
3
1,000,000/m
6,180/m
M6
NS
NS
NS
NS
NS
NS
28,300/ft
3
175/ft
3
3
3
100,000
NS
NS
NS
100,000/ft
NS
700/ft
NS
NS
3
3
3,530,000/m
24,700/m
M6.5
NS
NS
NS
NS
NS
NS
100,000/ft
3
700/ft
3
K
3
3
3
3
NS
NS
NS
3,500,000/m
NS
20,000/m
4,500/m
500/m
D
3
3
NS
NS
NS
3,500,000/m
NS
20,000/m
NS
NS
ISO 8
3
3
3
NS
NS
NS
3,520,000/m
832,000/m
29,300/m
NS
NS
3
3
10,000,000/m
61,800/m
M7
NS
NS
NS
NS
NS
NS
283,000/ft
3
1,750/ft
3
ISO 9
3
3
3
NS
NS
NS
35,200,000/m
8,320,000/m
293,000/m
NS
NS
L
200,000/m
3
45,000/m
3
5,000/m
3
NS
NS
NS
NS
NS
M
3
3
NS
NS
NS
NS
NS
NS
450,000/m
50,000/m
NS denotes Not Specified denotes Superseded
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_at_ViPLtd.co.uk
Web www.ViPLtd.co.uk
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