Equivalency study - Comparing 2 similar equipments

#1
Hi all,

I am currently working for a project in medical device industry. As part of adding an additional capacity, we are planning to do an equivalency study with a comparable equipment that is similar to what we currently use.

When inquired,validation group told me to test min and max setting of current equipment to the one that i am going to use. If the min and max works fine for new and comparable then equipment is fine to use.

My question here is if i use min and max setting in the new equipment and get results, will it be okay to compare (equivalency study in minitab) with historical nominal data as i have no min and max data for the current equipment and because of constraints in raw materials i cannot make comparison units in current equipment.

Please advice.

Please note: OQ and PQ in the current equipment is not complete. So i dont need to do a validation study.

Thanks!
 
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#2
You will define the Min and Max setting of the new equipment or follow the current equipment validated min and max setting?
My approach would be define the Min Nom and Max setting on new equipment and do equivalency study on Nom setting of current and new machine.
 
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