Process Validation of Rotary Heat Sealer Speeds

Melissa

Starting to get Involved
#1
Hello Everyone,
I am looking for advice on a Validation protocol that I am doing...I am trying to validate the Line speed in correlation to speed dial setting. Its the speed of a Rotary Heat Sealer, any ideas on how to validate the speeds? :)
Thanks in Advance!
 
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William55401

Quite Involved in Discussions
#2
Quick response. Before executing a validation, you need to do the homework to define your process window. Some orgs call these "Engineering Evaluations". These result in technical reports that are an input to your formal OQ and PQ runs for validation. Said differently, before executing validations, figure out the parameters that will work to avoid the pain of explaining a validation failure , and then resolving it, within your QMS.

How would I approach the engineering evaluation? I would think high energy and low energy and center points. DOE is always a good tool at this stage. Your inputs are speed and temperature? Run low temp and high speed. Run high temperature and low speed. Use your planned acceptance criteria. (what makes the seal good) as the test to determine acceptability. The best is to have variable data as a success measure. You may have a couple of iterations of evaluations before you tell management you are confident in the parameters and probability of validation success is high.

Hope this helps. Have fun. Enjoy the ride.
 

Melissa

Starting to get Involved
#3
I would be using same temperature i need to figure out the speed at 2 specific dial settings. I would use the Peel Strength to determine acceptance. this was actually done backwards as the peel validation was done on temp and 2 speeds and went fine. I was told by the auditor that I need to validate the speeds (which are 6 and 8) and convert how many ft per minute run through the machine. Is this making sense?
 

William55401

Quite Involved in Discussions
#4
Yes. This helps. The auditor wants to know (as should you) what does 8 (or 6) mean in terms of engineering units of measure. Your process input needs to be verifiable and defined in feet per minute. Think of this as an IQ task. Just like you have a controller that states temperature, how do you know it is correct? Orgs verify controller accuracy by using thermocouples as part of IQ. Apply the same thinking to the speed. How can you measure it to ensure 6 gets you exactly (with a tolerance) XX feet per minute. Periodic checks on the true speed delivered need to be part of your daily process checks. HTH.
 

Melissa

Starting to get Involved
#5
Thank you. Couldn't this be part of my revalidation later? I don't see the need to do daily checks as we do not use that machine daily.
 
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