Cleaning validation for Molding Tools?

R

rina120

#1
Hello,
I am tasked with finding out how to "validate" the cleaning process that we use for our molds.
We use a combination of mineral spirits, acetone, etc combined with manual disassembly of some components.

How far do we need to go to ensure the cleaning process is validated?


There is no cleaning step downstream, but there is terminal sterilization.

Thanks so much in advance!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello,
I am tasked with finding out how to "validate" the cleaning process that we use for our molds.
We use a combination of mineral spirits, acetone, etc combined with manual disassembly of some components.

How far do we need to go to ensure the cleaning process is validated?


There is no cleaning step downstream, but there is terminal sterilization.

Thanks so much in advance!
Start off with a risk analysis.

What's the purpose of the cleaning? What are you trying to remove? What level of absence (for each potential contaminant) would constitute a "Clean" state for your needs? What might be the consequences in case of failing to achieve that?

Once you know what to look for, and how prudent you need to be, you'll know how to test it and how to validate it.

I don't think that the sterility aspect is too relevant - most viable contaminants would become nonviable during molding (>>100degC). I'd expect most of your concerns to be related to nonviable contaminants staying on or in the molded part. Also, don't forget to address potential residues from the cleaning materials themselves.

All the best.
Ronen.
 
R

rina120

#3
Thanks Ronen for your reply!
So it seems I should still apply the principles from Drug product.

Thanks again
 
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