ISO and USA Cleanroom Standards
ISO and USA Cleanroom Standards
ISO and USA Cleanroom Standards
Verification
focuses on
Environment
PROCESS PEOPLE
The World Leader In Particle Counting www.particle.com
Cleanroom Control
ENVIRONMENT
Monitoring
focuses on
• PROCESS
• PEOPLE
PROCESS PEOPLE
The World Leader In Particle Counting www.particle.com
Cleanroom Control
ENVIRONMENT
ISO 14644-1, -2
Verification
FS 209 E
GMP, cGMP
FDA Guidelines Monitoring
ISO 14644-3
PROCESS PEOPLE
The World Leader In Particle Counting www.particle.com
Recent ISO Documents related to cleanrooms
ISO Document Title Status
ISO 1 10 2
ISO 2 100 24 10 4
Minimum number of
1 1
samples at each location
Note: Typical sample volume may be larger than minimum listed above especially for
smaller size particles in very clean areas (better than ISO Class 5 or FS 209E Class 100)
250
200
150
100
50
0
50 100 150 200 250 300 350 400 450 500
Floor Area in square meters
Generally, ISO 14644-1 and -2 require fewer number of sample positions because the
number is calculated by taking the square root of the floor area in square meters.
60
50
40
30
20
10
0
50 100 150 200 250 300 350 400 450 500
Floor Area in square meters
Generally, ISO 14644-1 and -2 require fewer number of sample positions because the
number is calculated by taking the square root of the floor area in square meters.
Because this Class is non-unidirectional or turbulent, FS 209E requires fewer points.
Maximum Time
Test Parameter Class Test Procedure
Interval
Particle Count
<= ISO 5 24
6 Months
ISO 14644-1
Test Annex A
> ISO 5 12months
Months
Important
Air Pressure note: If Particle counts and Differential
All Classes 12 Months
ISO 14644-1
Difference Annex B5
Pressure are monitored continuously (for
example, by a Facility Monitoring System) then
ISO 14644-1
Airflow
the MaximumAllTime Classes
Interval12for
Months
re-certification
Annex B4
can be extended to 24 months.