Aging rig in medical device industry - To qualify or not

#1
Hi,
I need some help in my thinking and to do some bench marking.

I'm working with medical device and in R&D we do component verification.
Part of component verification is to do stress tests / aging tests where the components are exposed to cold/heat/chemicals/pressure etc using a purpose built test rig. The rig is built upon calibrated sensors and a control software.

If the test rig would gather any measurements I gladly classify the rig as GxP and thus be subject to qualification (validation) according to our procedures.
However, the rig does not take any measurements or gather any results. It purpose is only to expose the components during a predetermined time.


  1. If you have similar equipment - do you qualify (IQ/OQ) or anything else?
  2. What did you base your decision on for how to treat the rig?
Thank you!
 
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Ronen E

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#2
How can you be sure that the rig did what you intended it to do? I suppose no one sits there to supervise it while it works.
 

yodon

Staff member
Super Moderator
#4
I'll "third" Ronen's response and agree qualification is needed. You're making quality decisions based on the use of the equipment so you need to have confidence that the equipment is doing what's intended.

Further, since it has control software, the software itself should be validated!
 
#5
Thank you all!

I actually think I can draw a parallel to the use of a climate chamber, which I would always qualify.
The chamber itself do not measure anything on the component, but I want to be sure it works as expected.

(Comment - the people voting for non-qualification will claim that it is not GxP and it can be controlled by calibrating sensors before and after test run to reassure it has performed as expected)

Cheers!
 
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