Particle Measuring Systems LASAIR II 310 Operator's Manual page 115

Chapter 8: Statistics Mode Chapter 8: Statistics Mode
Page 8-4 Page 8-4
EC-GMP Stand EC-GMP 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
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, the EC-GMP standard uses most of the As a derivative of the ISO standard,
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
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.
Simulta Simultaneous EC-GMP and neous EC-GMP and ISO:
user to sample the cleanroom one time, then generate reports for user to sample the cleanroom one
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
LASAIR II. LASAIR II.
T T able 8-2: able 8-2: EC-GMP Class
A A t t R R e e s s t t
G G r r a a d d e e 0 0 . . 5 5 µ µ m m
A A 3 3 , , 5 5 0 0 0 0
B B 3 3 , , 5 5 0 0 0 0
C C 3 3 5 5 , , 0 0 0 0 0 0
D D 3 3 , , 5 5 0 0 0 0 , , 0 0 0 0 0 0
Table 8-3: ISO Classes Corresponding to EC-GMP Classes Table 8-3: ISO Classes Corresponding to EC-GMP Classes
E E C C - - G G M M P P G G r r a a d d e e A A t t R R e e s s t t
A A
I I S S O O 5 5
B B I I S S O O 5 5
C C I I S S O O 7 7
C C I I S S O O 8 8
LASAIR II II Operator's LASAIR
the EC-GMP standard uses most of the ISO
the sample volume is the same as ISO.
ISO: The EC-GMP & ISO mode allows the
The EC-GMP & ISO mode allows the
time, then generate reports for
EC-GMP Class Standards Standards
Maximum Particles per M Maximum Particles per M
I I n n O O p p e e r r a a t t i i o o n n
5 5 µ µ m m 0 0 . . 5 5 µ µ m m
1 1 3 3 , , 5 5 0 0 0 0
1 1 3 3 5 5 , , 0 0 0 0 0 0
2 2 , , 0 0 0 0 0 0 3 3 , , 5 5 0 0 0 0 , , 0 0 0 0 0 0
2 2 0 0 , , 0 0 0 0 0 0 n n o o t t d d e e f f i i n n e e d d
I I n n O O p p e e r r a a t t i i o o n n
I I S S O O 5 5
I I S S O O 7 7
I I S S O O 8 8
N N / / A A
Operator's Manual Manual
ocument is intended to be
Minimum Total of 1 m otal of 1 m
both both
the the
concurrently with the
3 3
5 5 µ µ m m
1 1
2 2 , , 0 0 0 0 0 0
2 2 0 0 , , 0 0 0 0 0 0
n n o o t t d d e e f f i i n n e e d d
ISO
3 3
for for