Injection Molding Machine Validation Scope

#1
Can someone provide list of requirements needed to validate molding machine only?
Or provide a document or link for the information?

Thanks,
 

Golfman25

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#2
If I was only concerned about the machine I would want validation that it can maintain temps., injection speeds, and transfer positions.
 

Marc

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#4
validation that it can maintain temps., injection speeds, and transfer positions.
Agree - Been there - Done that. Were it me, yes. OP - Think of it this way - What are your critical process equipment parameters.

I can't speak to software validation in this scenario. Hopefully someone else can.
 
#5
Typically, you need to verify all the "usual suspects" safety, power supplied, etc. Also, modern injection molding machines (IMM) that I've worked with and validated include PLC software which typically must be validated also. This software is typically validated by a "Black Box Test", essentially ensuring that the machine output is what's expected give specific machine inputs. The first step in this software validation would be to determine what you consider to be critical parameters. I would suggest that injection location (distance), screw rotational velocity, perhaps a pressure and a temperature that are setpoints. Then you need to determine how you will ensure that you are getting the desired output for a given input setting. For most machines, your input will be translated by the software into an analog signal that controls the necessary servos, etc., but you may need to check with the machine manufacture to determine how and where to measure this and how the analog signal relates to the input. For example, on one of our Milacron IMMs there is an analog card where the signal can be measures and the signal ranges from 0 to 10 volts linearly with minimum and maximum screw rotational velocity, etc.
 

leftoverture

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#7
Can someone provide list of requirements needed to validate molding machine only?
Or provide a document or link for the information?

Thanks,
The first question I have for you before replying is what are you trying to validate and for whom? In other words, what is your goal for validation? If you can tell us that, I think we can better hone in on what the requirements for your specific scenario might be.
 
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