Page 8-4 Lasair II Particle Counter Operations Manual
Chapter 8: Statistics Mode
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EU-GMP Standard
The EU-GMP standard is similar to the ISO-14644 standard. This standard is based
on the document “EU Guide to Good Manufacturing Practice; Revision to Annex
1.”
As a derivative of the ISO standard, the EU-GMP standard uses many of the ISO
rules. However, a comparison between the two stnadards show the differences in
teh sampling required as well as the particle concentrations.
• For Grade A the sample volume is a Minimum Total of 1 m
3
.
• For Grade C or Grade D the sample volume is the same as ISO.
Simultaneous EU-GMP and ISO: The EU-GMP & ISO mode allows the user to
sample the cleanroom one time, then generate reports for both the
EU-GMP and the ISO-14644 standards. Table 7-2 shows EU-GMP and
corresponding ISO classes that can be calculated concurrently with the
Lasair II particle counter.
Table 8-1: EU-GMP Class Standards
Maximum Particles per M
3
At Rest In Operation
Grade 0.5 µm 5 µm 0.5 µm 5 µm
A 3,520 20 3,520 20
B 3,520 29 350,000 2,900
C 350,200 2,900 3,520,000 29,000
D 3,520,000 29,000 not defined not defined
Table 8-2: ISO Classes Corresponding to EU-GMP Classes
EC-GMP Grade At Rest In Operation
A ISO 5 ISO 5
B ISO 5 ISO 7
C ISO 7 ISO 8
D ISO 8 N/A
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