Under correct cGMP Fluidizing Cartia required highly skilled Operators.
With my six [6] years experience at Andrx now took over by Watson
Pharmaceutical. Set up is very important ,Filters used in the 24"
Wuster column is very important. Wuster column alignment is also
very important. The height of the column is also important.
The active pellet must be able to flow smoothly to allow
the proper coating of the pellets. The suspension consist of a
greater portion of Talc and continuous steering of suspension
must be maintained during the spraying process.
Nozzle cap and tips must be properly set up by a trainned
technician. During the spray period particle of the pellet are
monitored to adjust the spraying also spray rate and spraying
parameter are maintained as stated in the Batch Record.
Periodical reading are document in the the batch record
under cGMP Regulated by the FDA.
At the end of the coating period LOD is taken to
give and indication of the moisture during the heat stage
of the pellets in the wuster. The [low on dry ] measured
must be within parameters as specified in the Batch Record.
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