How to perform validation for an epoxy curing station

#1
Hi All,

Need some advice on how to perform validation for an epoxy curing station. Basically what we do is to pour epoxy into one of our sub assembly and bake it in the oven for 10-12hours at 70 degree celcius. According to the engineer, the temperature is not critical because the epoxy can also cure at room temperature but it may take longer time. The problem is we have no way of testing whether the epoxy has cured thus we have to validate this process.

Thank you in advance for your help :D
 
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somashekar

Staff member
Super Moderator
#3
Attached is the datasheet for the epoxy that we are using. Actually i am thinking is validation necessary for this process? If not then how to justify that validation is not required?

Thank you!
There are variables suggested in the data sheet and you are going to pick the one that best suits your application. So we are talking about a simple validation, and this is not rocket science at all.
You will also consider the curing temperature taking into consideration the temperature capability of other materials involved in the system, like ex: the material of the case in which the casting is done.
One sure way is to test the hardness after curing (use details provided in the data sheet). You could do this on your product directly if possible., or cast a specimen for the hardness test.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Attached is the datasheet for the epoxy that we are using. Actually i am thinking is validation necessary for this process? If not then how to justify that validation is not required?

Thank you!
Start off with a risk evaluation - what might happen if it doesn't properly cure? What would have happened if you didn't bake it at all?
 
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