Professional Documents
Culture Documents
Martin Derks
Lighthouse Worldwide Solutions Benelux BV
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Title Change
Classification Table and (u,M) definitions
New Classification Table
Impact on GMP table
Macro Particle Descriptor
Sample Locations
Informative Annex A Cn
The upper confidence level (UCL 95%) evaluation
Annex F, Sequential Sampling
ISO14644-Series
Contaminant
Air Cleanliness by .
Particles
Chemicals
SCC: 14644-10
Surface Cleanliness by
Chemical concentration
Nanoparticles
Viables
ACV: 14698-9
Air Cleanliness by Viables
ISO 14644-1:2015
Title Change
ISO 14644-1:1999
Part 1 : Classification of air cleanliness
ISO 14644-1:2015
Part 1 : Classification of air cleanliness
by particle concentration
ISO 14644-1:2015
Title Change
ISO 14644-2:1999
Part 2 : Specifications for testing and
monitoring to
prove continued compliance with ISO
14644-1
ISO 14644-2:2015
Part 2 : Monitoring to provide evidence
of cleanroom
performance by air cleanliness by
particles (ACP)
Impact for users:
No change, documentation only
ISO 14644-1:2015
Ultra and Micro (u,M) Descriptors
ISO 14644-1:1999
Smaller than 0.1 microns defined ad u,
larger than 0.5 microns defined as M.
ISO 14644-1:2015
Smaller than 0.1 micron particles will no
longer exist in ISO 14644-1. This issue
will address in ISO 14644-12 (Air
cleanliness by nano particles.
Impact for users:
Classification can be done for smaller
particles (<0,1m) and larger particles
using M descriptor
0.1m
b
10
100
1,000
10,000
100,000
1,000,000
c
c
ISO 9
0.2m
d
0.3m
d
24
10
237
2,370
23,700
237,000
c
c
102
1,020
10,200
102,000
c
c
0.5m
d
d
1.0m
d
d
d
5.0m
e
e
35
352
3,520
35,200
352,000
3,520,000
83
832
8,320
83,200
832,000
35,200,000
8,320,000
e
e
d,e,f
29
293
2,930
29,300
293,000
ISO 14644-1:2015
Should ISO Class 5 include 5.0 micron as a test size?
ISO 14644-1:1999
ISO Class 5 ; 5.0 micron : 29 pcs.
ISO 14644-1:2015
No more ISO Class 5 ; 5.0 micron
definition.
Impact on users :
Firmware revision. Recipe & reports
revision
Also different algoritms due to d and e.
Will make a difference between GMP
and ISO reports.
New ISO 14644-1:2015
GMP ANNEX 1
MANUFACTURE OF STERILE MEDICINAL PRODUCTS
Operational
5.0m
0.5m
5.0m
3,520
20
3,520
20
Class limit of B
29 parts 5.0
micron outsideC
scope
D
3,520
29
352,000
2.900
352,000
2.900
3.520.000
29.000
3,520,000
29.000
Not Defined
Not Defined
scattering
airborne
particle counter
M=
Macroparticles
20 =
Class limit
from GMP
Considered
particle
size
ISO 14644-1:2015
Informative Annex A (Cn Definition)
ISO 14644-1:1999
0,1
Cn= 10 [ D ]2,08
ISO 14644-1:2015
Table 1 only, no Cn formulation
No more decimal classes. (4.8 etc.)
Annex F for intermediate decimal
cleanliness classes (3.5, 4.5, 5.5 etc.)
Impact on users :
Not frequently used; change reporting
0.1m
b[32]
316
3.160
31.600
316.000
3.160.000
c
c
0.2m
d
b[75]
748
7.480
74.800
748.000
c
c
0.3m
d
b[32]
322
3220
32.200
322.000
c
c
Cn= 10 [D ]2,08
e.g. 0,4m
New ISO 14644-1:2015
0.5m
d
d
d
1.110
11.100
111.000
1.111.000
11.100.000
1.0m
d
d
d
263
2.630
26.300
263.000
2.630.000
5.0m
e
e
e
e
e
924
9.240
92.400
ISO 14644-1:2015
Sample Numbers and Locations
ISO 14644-1:1999
Square-root Method for sample
numbers. N=
ISO 14644-1:2015
Table A.1. (Fixed numbers)
A
[
]
1000
2
4
6
8
10
24
28
32
36
52
56
64
68
72
76
104
108
116
148
156
192
232
276
352
436
500
1000
>1000
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
Equation A.1
FOR LARGE
ENCLOSURES
MORE
SAMPLING
POINTS
90
80
70
60
50
FOR SMALL
ENCLOSURES
LESS
SAMPLING
40
30
20
10
0
1999
2015
ISO 14644-1:2015
UCL 95%
ISO 14644-1:1999
1<x<9 sample points, UCL 95% should
calculated
ISO 14644-1:2015
Removed completely.
Impact on users :
Particle Counter Firmware revision.
Reports, Recipes
Remove UCL 95%
Sequential sampling
Expected Counts =
25
20
Observed counts
15
10
0
0
Expected Counts
New ISO 14644-1:2015
10
15
20
,
1000
ISO 14644-1:2015
ISO 21501-4 Attribution
ISO 14644-1:1999
Latest standard available...
ISO 14644-1:2015
Calibration method clearly states that
ISO21501-4 should perform for particle
counter calibration.
Impact on users :
All particle counters should compliant
No more ISO9001 certs.
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