Struggling with Process and Sub-Process Validation - Brain Catheter

A

ago70

#1
Hello my first post here in the vrey helpfull forum.

Here is my concern/problem.

I read a lot about process verification and validation. Understood the differences and requirements. But I am struggling with follwoing " Validation bla bla ... that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics."

Am I right when I look at the pre-determined specification, then it will be very easy.

e.g. brain catheter:
should be free particles --> clean room conditions validation
should be free of infective ´substances --> Sterilization process validation

this is clear, but should I look also to subprocesses like a cleaning process of the catheter tube within the clean room. e.g. catheter has to be cleaned in a special solvent, if solvent is used you can verify it by change of the color, but if solvent is used to long the catheter migtht not accepted at the end test (100 % testing).
Should this subprocess be validated? If yes with which argumanetation.

Looking forward for an answer.

Kind regards,
Andreas

:notme:



 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". My Thanks in advance if anyone can help with this one.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello my first post here in the vrey helpfull forum.

Here is my concern/problem.

I read a lot about process verification and validation. Understood the differences and requirements. But I am struggling with follwoing " Validation bla bla ... that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics."

Am I right when I look at the pre-determined specification, then it will be very easy.

e.g. brain catheter:
should be free particles --> clean room conditions validation
should be free of infective ´substances --> Sterilization process validation

this is clear, but should I look also to subprocesses like a cleaning process of the catheter tube within the clean room. e.g. catheter has to be cleaned in a special solvent, if solvent is used you can verify it by change of the color, but if solvent is used to long the catheter migtht not accepted at the end test (100 % testing).
Should this subprocess be validated? If yes with which argumanetation.

Looking forward for an answer.

Kind regards,
Andreas

:notme:



Hello and welcome to the cove :bigwave:

You must validate processes where the outcome can't be reliably and economically verified on the process's product (e.g. when you would need a 100% destructive test).

If you have a process with 100% inspection (that was established as being reliable), and you're happy with it from an operations / business perspective, then most likely you don't have to validate it.

Cheers,
Ronen.
 
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