74
Performance-Test
Average Diameter (µm):
This is to set the PSL size for the test particles to be added.
Set it within the system permitted size range of countable particles
of 1.3 to 100 µm (0.1 µm step).
Subtract CV for the Resolution?:
Select this when the CV value(s) of the particles shall be subtracted
calculating for resolution calculating
CV of the PSL (%):
Check ‘Subtract CV for the resolution?’ to be able to enter values in
CV of the PSL (%). Set the CV value of the particles, which shall be
subtracted. The allowable setting range is 0.01 to 9.99%.
Minimum Concentration (/mL):
This sets the minimum number concentration of the count test sus-
pension. The allowable setting range is 100 to 9999 particles / mL
(1 particle / mL step).
Maximum Concentration (/mL):
This sets the maximum number concentration of the count test sus-
pension. The allowable setting range is 101 to 10000 particles / mL
(1 particle / mL step).
Test Method:
This selects a test method.
Note
JP will carry out tests on sensor resolution, particle counting accu-
racy, the threshold accuracy stipulated by Japan Pharmacopeia.
USP will carry out the Sensor Resolution stipulated by United
States Pharmacopeia.
“Set” button:
Click after setting the diameter for the test particle(s). An “Add
New PSL” window closes, then a particle group list is added to the
“PSL (General)” list.
“Edit” button: Use this to change the particle diameters or upper threshold setting.
Select a required PSL size from the “PSL (General)” list to edit. Click
to display the “Edit PSL Parameter” window.
Note
The setting for the “Edit PSL Parameter” window is the same as
the one for the “Add New PSL” window. See the explanation of
the previous “Add New PSL” window for further setting details.
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