[quote=yodon]Yes, that’s where the challenge is.
The general process would be to determine what the range is that results in good product and then do statistically-significant testing at the range end.
To determine the operational range, you may need to do some experimental testing (outside the scope of the validation).
Since the title of this thread mentions blister sealing machine, I presume there are at least 2 variables in play: heat (if thermal) or frequency (if ultrasonic) and dwell time. Introducing multiple variables like that increases the complexity of the testing (and determining the parameter ranges).
It would be difficult in a forum like this to provide details more specific for your problem. Hopefully that gets you going a bit.[/quote]
The dwell time would be an input variable or an output variable in a design of experiment?
How can I measure dwell time?
What would be the parameters that affect the measure responses or output (dependent) variables?
Attentive to your comment.