Page
Page 8-4
8-4
LASAIR
LASAIR II
II Operator’s
Operator’s Manual
Manual
Chapter 8: Statistics Mode
Chapter 8: Statistics Mode
EC-GMP
EC-GMP Stand
Standard
ard
The EC-GMP standard is based on the document “EC Guide to Good
The EC-GMP standard is based on the document “EC Guide to Good
Manufacturing Practice; Revision to Annex 1.” This d
Manufacturing Practice; Revision to Annex 1.” This document is intended to be
ocument is intended to be
based on the ISO-14644 standard and describes modifications to the standard
based on the ISO-14644 standard and describes modifications to the standard
for EC-GMP classifications. Classifications for EC-GMP are shown
for EC-GMP classifications. Classifications for EC-GMP are shown in
in
Table 7-2.
Table 7-2.
As a derivative of the ISO standard,
As a derivative of the ISO standard, the EC-GMP standard uses most of the
the EC-GMP standard uses most of the ISO
ISO
rules. However, a comparison of maximum particle counts between the two
rules. However, a comparison of maximum particle counts between the two
standards shows that the EC-GMP is slightly different. The minimum sample
standards shows that the EC-GMP is slightly different. The minimum sample
volume is also different between the two standards.
volume is also different between the two standards.
••
For Grade A or Grade B the sample volume is a
For Grade A or Grade B the sample volume is a Minimum T
Minimum Total of 1 m
otal of 1 m
3
3
for
for
sum of all samples taken.
sum of all samples taken.
••
For Grade C or Grade D
For Grade C or Grade D the sample volume is the same as ISO.
the sample volume is the same as ISO.
Simulta
Simultaneous EC-GMP and
neous EC-GMP and ISO:
ISO:
The EC-GMP & ISO mode allows the
The EC-GMP & ISO mode allows the
user to sample the cleanroom one
user to sample the cleanroom one time, then generate reports for
time, then generate reports for
both
both
the
the
EC-GMP and the ISO-14644 standards. Table 7-2 shows EC-GMP and
EC-GMP and the ISO-14644 standards. Table 7-2 shows EC-GMP and
corresponding ISO classes that can be calculated
corresponding ISO classes that can be calculated concurrently with the
concurrently with the
LASAIR II.
LASAIR II.
T
Table 8-2:
able 8-2: EC-GMP Class
EC-GMP Class Standards
Standards
Maximum Particles per M
Maximum Particles per M
3
3
A
At
t
R
Re
es
stt
IIn
n
O
Op
pe
erra
attiio
on
n
G
Grra
ad
de
e
0
0..5
5
µ
µm
m
5
5
µ
µm
m
0
0..5
5
µ
µm
m
5
5
µ
µm
m
A
A
3
3,,5
50
00
0
1
1
3
3,,5
50
00
0
1
1
B
B
3
3,,5
50
00
0
1
1
3
35
5,,0
00
00
0
2
2,,0
00
00
0
C
C
3
35
5,,0
00
00
0
2
2,,0
00
00
0
3
3,,5
50
00
0,,0
00
00
0
2
20
0,,0
00
00
0
D
D
3
3,,5
50
00
0,,0
00
00
0
2
20
0,,0
00
00
0
n
no
ot
t d
deeffiin
need
d
n
no
ot
t d
deeffiin
need
d
Table 8-3: ISO Classes Corresponding to EC-GMP Classes
Table 8-3: ISO Classes Corresponding to EC-GMP Classes
E
EC
C--G
GM
MP
P G
Grra
ad
de
e
A
At
t R
Re
es
stt
IIn
n O
Op
pe
erra
attiio
on
n
A
A
IIS
SO
O
5
5
IIS
SO
O
5
5
B
B
IIS
SO
O
5
5
IIS
SO
O
7
7
C
C
IIS
SO
O
7
7
IIS
SO
O
8
8
C
C
IIS
SO
O
8
8
N
N//A
A
