Solution Prep for Cartia

The amount and weight of solution will vary with batch sized.
Verified that all equipment to be used are listed in the batch record.
Verified that all equipment are cleaned and documented in their
individual log book. Verified that all equipment and room to be
used are released by Quality Assurance .
Check and verified all component to be used are current
and not expired. Many time company lost lots of money by
using one expired component in the solution preparation .
Verified equipment setup checked by another experience
operator.
For cartia the following equipment are used triblender,
mixing tank, holding tank, tacometer,valves and clamps and
high power connecting hose or solution tubes.
Connect the mixing tank with the hole at the bottom to the
lower part of the triblender and the top hole of the mixing
tank to upper end of the triblender. The connection should allow
an easy flow of suspension from the triblender to the mixing tank.
Verified and checked for the correct connection by a second
operator.




The component for the solution prep for cartia includes
polysolbate, polyglycol, talc 1 and talc 2, purified water and
the main polymer eudragit . Dispense and weigh the purified
water.
Close all valve at bottom of the mixing tank turn the mixer
and use the tacometer to measure the rpm on the mixer.
Document as specified in the batch record. Verified by
and checked by at all stage of solution prep immediately
as performed.
Attached all weighing labels and component labels
in the batch record.
Add the component step by step as stated in the batch
record. Document time ,date and duration in the batched
record. When the mixing of the component is completed
closed the bottom valve part of the mixing tank and
allow the mixture to empty in the mixing tank from the
triblender. Stopped the triblender and disconnect the top part
of the mixing tank and connect with the top part of the holding
tank with the weigh polymer[ eudragit]
Start the triblender open the bottom valve with
the mixture and allow it to flow into the polymer.
Not the reverse.
Weigh the content and ajust mixing speed in the holding tank
document and check by for weight time duration of mixing
as specified in the batch record.

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