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Batch to Batch Change Over Line Clearance Checklist

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B

Binome

#22
#22
Thanks !

So, you said that you have implemented a batch over batch process without stopping the machine. I'm exactly in the same situation. I would like to change tablet's batch without stopping the machine.

I'm thinking about producing an amount of tablets between the two batches to "empty" the machine of the previous batch's powder.

Actually I tried to find some information in Guidelines but I found only :

a cleaning procedure requiring complete product removal may not be necessary between batches of the same drug

But I would like to know if reglementation allow batch to batch process without stopping and emptying the press...

What do you think about that ? How did you your batch to batch process without stopping the machine ?

Thxs a lot
 
F

FAndrade

#23
#23
FDA totally aproves the use and implementation of continuos manufacturing. Let me quote a CFR definition about batch, which is regulated by the FDA:

"Batch
A specific quantity of material produced in a process (or series of processes) and expected to be homogeneous within specified limits. The batch size may be defined either by fixed quantity or the amount produced in a fixed time interval. In the case of continuous production, a batch may correspond to a defined fraction of the production characterized by its intended homogeneity."

On my process, we have a reactor tank (where we prepare the solution) and then a buffer tank of the same capacity, which the filling machine take the solution to fill bottles . On batch over batch, we prepare "B" batch over the remanent of the "A" batch. We add the "B" raw material over the "A" solution, and the we add the proper water to complete the solution.

Take some links that can help you a lot:

www. pqri. org/ workshops/SampleSize/Moore.pdf - DEAD LINK UNLINKED (404)

www . gmp-compliance .org/daten/download/ShortPaper_ContinuousProcessing_Muzzio.pdf - DEAD LINK UNLINKED (404)

www.gmp-compliance.org/ecanl_503_0_news_3268_7248_n.html

www. ipec -europe. org/uploads/continuous_gmp_ispe09_presentation_template.pdf - DEAD LINK UNLINKED (404)
 
Last edited by a moderator:
B

Binome

#24
#24
Wow thank you very much !
I red rapidly, I'm gonna work in one our, I'll check that soon ! But it seems to be perfect ! Thanks a lot

EDIT : So it seems not to be, it is ! :D
 
Last edited by a moderator:
B

Binome

#26
#26
One question more, Fanrade, when you add the B batch over the A batch are you mixing all ? Is A's concentration uniform into B batch ?

Which maximal concentration did you choose of A in B ? And when do you consider that you're producing the B batch ?
 
F

FAndrade

#27
#27
Let me please correct myself:


"On my process, we have a reactor tank (where we prepare the solution) and then a buffer tank of the same capacity, which the filling machine take the solution to fill bottles . On batch over batch, we send "B" batch (in the reactor tank) over the remanent of the "A" batch (in the buffer tank) until the reactor is empty. On this way the machine always have solution to fill bottles, and the reactor is empty to prepare a new solution. So, the new batch, "C" is prepared on the reactor and will be send over the remanent of the "B" batch on the buffer tank".


Thats what I wanted to say. A, B and C batch have always the same concentration and uniform (checked with QC area).
 
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