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Lighthouse Handheld 2016 - Iso 14644-1; Eu Gmp 2009

Lighthouse Handheld 2016
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Lighthouse HANDHELD 2016, 3016, 5016 Gen F Operating Manual
5-2
248083400-1 Rev 7
For the Fed Std 209E (ft) 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 minimum number of locations is 1.
At least 1 sample must be taken per location.
At least 3 samples, total, must be taken in the cleanroom. The user can
take a different number of samples at different locations.
The minimum sample volume is 2 liters.
This report has a minimum Sample Time of 1 minute. If the Sample
Time is less than that, the entire room would fail the classification.
The 95% Upper Confidence Limit (UCL) must be calculated if the
number of sampled locations is less than or equal to 9.
EU GMP 2009
The EU GMP 2009 only applies to 2 channel sizes: 0.5μ and 5.0μ.
There are only 4 Classes: A, B, C, D, and 2 cleanroom states: At Rest
and Operational.
Class D is not applicable when the cleanroom is Operational.
If one of these channel sizes is not present, the report cannot classify
the room.
The standard does not define a minimum number of sample locations
or a minimum number of samples. In order to take a measurement, at
least 1 location and 1 sample are required by the counter.
The standard does not require a minimum sample volume. The volume
of air must be shown in liters (L).

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