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Lighthouse ApexPortable Series - Report Requirements; Fed Std Ft3; Iso 14644-1; Eu Gmp 2009

Lighthouse ApexPortable Series
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Lighthouse ApexPortable Operating Manual
5-42 248083440-1 Rev 5
Report Requirements
Fed Std ft
3
This report requires a minimum of 2 locations be measured, at least 1
sample be taken per location and at least 5 samples total be taken in
each cleanroom at a minimum sample volume of 0.1 cubic feet.
The 95% Upper Confidence Limit (UCL) will be calculated by the
ApexPortable if the number of sampled locations is equal to or less
than 9.
Air flow (Unidirectional vs. Non-unidirectional) will have an effect on
the minimum locations and minimum samples required. In general, the
Non-unidirectional option requires more of both locations and samples.
For the Fed Std ft
3
report, the classification for a particle size is based
on its samples taken from all locations in the cleanroom. Each particle
size is given one of the following results:
a classification rating which will be one of the possible
classifications (1, 10, 100, 1000, 10000, 100000)
“Unable to Classify” if it fails one of the above requirements
an “Out of Range” if the calculated classification at that particle
count exceeds 100,000
ISO 14644-1
The ISO14644-1 standard requires a minimum 60 second Sample Time
for each sample recorded.
Note:
The EU GMP 2009
report is only valid if the
instrument is configured with
the 0.5 and 5.0 micron
channel sizes and these sizes
are active.
EU GMP 2009
The EU GMP Standard Report requires the unit has the channel sizes
0.5μ and 5.0μ as these are the only channels that apply to this standard.
The EU GMP Report has different concentration limits for cleanroom
status “At Rest” versus “In Operation”. When the cleanroom is “In
Operation”, Class D is not available because the standard is not defined
for Class D in an operational cleanroom.

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