Solution Prep For Tastia

The size of the batch may vary from one Pharmaceutical Company

to the next.Such may vary with the amount of solution prepared.

Verified that the equipment needed for solution prep are listed

in the batch record . Equipment needed are two are mixer one

with a 6" diameter blade and the other with a 4 " diameter

blade. Two 15 gallons holding tanks , A tacometer, A 40 gallon

holding tank with a mixed that may vary with the size of the

batch. Verified all equipment are cleaned and are with the time

limitation.

Check all component needed for the solution prep and

also check for their expiration date.

Verify all equipment and components are document in the

batch record and are check by a second operator. Request a room

release by Quality Assurance after all documenting is done in the

batch record.

Solution can be done as soon as the room is released.

Dispensed the correct amount of purified water as pecified in

the batched record. Placed the 6 " diameter mixer into the holding

container .Set the mixer speed as stated in the batch record using

a tacometer.Add the etheocellulose in the water duration should

take at least 10 min . Ajusted the mixer speed as specified in the batch

record let it mixed for 60 mins. After mixing for that period of time

make sure all verified by and check by are documented in the

batch record. Also stopped the mixing and let it defoamed for 30 mins

While defoaming dispense a quantity of alcohol into a holding container

as specified in the batch record. Place the 4 " daimeter blade into the

container of alcohol adjust mixer speed as stated in the batch record.

After defoaming adjust the mixing speed to add the talc in the

etheocelluose. Let the mixture continue mixing and document the step

into the batch record get check by.

With the 4" blade mixer in the container of alcohol add the polysolbate

in the container and document the time and duration in the batch record

also initial and date and check by in the batch record.

Add the magnesium stearate in the solution of alcohol and polysolbate

and let it mixed for the time stated in the batch record.

Upon completion pour the solution into the othe container

with the talc and etheocellulose continue mixing as stated in the batch

record.

Dispensed the stated amount of polymer [eudragit] into the

holding tank and mixer verify by and checked by the weight.

When the mixing of the previous solution is done mixing

stopped the mixing and set the mixer on the holding tank with polymer

to the stated rpm. Add the solution on to the mixing polymer to complete

the general solution. Allow the mixing to continue for about 15 mins

before coating.



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