End phase – from time T2 until time T3, this is generally set to include
the region where the particle size starts to increase towards the end of the
spray event. This phase is termed the dissipation phase by the FDA guidance.
.
Select the Start, Middle and End check boxes. Specify a time in millisec
-
onds after the trigger to mark when T1, the point when the stable phase be
-
gins, is expected to occur. Repeat this for T2, the end of the stable phase.
For End, select the To end of event check box.
.
In some cases, it may be useful to save the average of each of the phases in a
new Particle Size History (.psh) file as well as in separate .psd files. To do
this enable the option Create Particle Size History in addition to PSD
window for each phase.
.
From the Phase Average dialogue click OK., then Next then Finish.
When prompted to save the new SOP, give it a name which will make it
easy for operators to identify what it is to be used for.
.
The SOP can now be run as described at the end of this chapter.
CHAPTER 5
Spraytec
Page 5.22 MAN 0368
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