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Electromagnetic Interference / Compability in Instalation Qualification

Does anyone had cite electromagnetic interference / compability (EMI / EMC) in equipaments IQ protocols or in a risk analysis? If so, could you share your knowledge? Had you done any test, or justified a rational based on FCC (CE, or other labels) declarations?

Jared: I don’t know how to continue the discussion adding a new answer to this topic, that’s why I’m editing it.

The application is for facility qualifications (equipaments on production lines and in laboratories)

I haven’t seen it. External power supply requirements are typically stated in the Installation Qualification (IQ). But it could be required for an surgical implanted heart defibrillator in order to demonstrate robustness of the device.

I have seen this in some protocols for a very large client with surplus headcount and deep pockets years ago. I have Mostly for electrical cabinets. I had no idea what it meant, and I let the electricians handle it. I have heard rumors of this causing an issue on one client site I was at, for one application. I also could see this being a part of a commissioning document rather than an IQ.

You didn’t mention what your application was - I wouldn’t have thought of heart defibrillators. Is this for facility, equipment qualification, or for medical device, etc?

I don’t have much more background/experience than this. Sorry.

I think that the fields of knowledge might be far apart to have much cross-over. That is, I can see some fields which are saavy on the radiointerference, but I just don’t think most pharmaceutical validation or engineers are too aware of radio-interference.

But I’ll take a shot/guess at answering. The electromagnetic interference can affect EM signals. Do you have EM signals which need to be protected? Are you sending/receiving data near your process? Are you collecting data wirelessly for your process? Or is your wireless just for phone and internet?

Even if your process send/receives data wirelessly I suspect that the liklihood of something going wrong is actually super low. - if you use a risk based approach you might find that the level of detection is high (low risk), the liklihood of failure is low (low risk), and impact to product is probably low as well (low risk). From this perspective, I think you could get away without testing for radio interference…

Again, I"m no expert, and I remember seeing it once a long time ago, and thinking it was a tad silly (again, I’m no expert, so I might get eviscerated here on this opinion).

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