Hello There,
Does anyone know about validation of injection moulding process?
Which machinesettings are normally included?
And how to determine the range of testing?
Looking forward to hearing from you,
BR
MBork
Hi MBork,
How to validate an injecting moulding process is a very broad question which I don’t think I will be able to answer in full, but here’s a starting point at least.
“Which machine settings are normally included?”
I assume you mean whicg machine setting are included in the validation study. The testing for the machine testing would normally occur in the Operation Qualification either under the title of process cycle or you might have a section which tests for actual machine settings. This depends on the organisation in question and what validation SOP’s they have in place.
Is this machine software controlled or are these setting controlled mechanically?
I would fully test all of the setting that are assocaited with the equipment and test for Alarms, Trips, Interlocks and any error messages that might occur if normal ranges are exceeded.
“And how to determine the range of testing?”
This is impossible to answer as a risk assessment would have to be performed initially. If this was the first time that this equipment was going to be validated then I would have fully validation the application, and then do partial validation on subsequent injection moulds if others are going to be installed on subsequent lines or facilities.
The Quality department would also have to have input as to the correct range of testing is required.
Hope that helps somewhat, hard to give a c[FONT=‘Times New Roman’]omprehensive when I don’t have the full picture.[/font]
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[FONT=Arial]Regards[/font]