When the mapping study says move the probe, do you need other criteria to relocate?

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Paul Daniel
Sr. Regulatory Compliance Expert
Sep 29th 2017
Industrial Measurements
Life Science
Science & Sensing Technologies

In this week's blog, Senior Regulatory Expert Paul Daniel offers some practical advice on moving probes in validation/mapping. Plus, you are invited to a webinar on sensing vaporized H2O2 in biodecontamination.

We received two questions by email...

Question 1: How do you recommend we assess the worst case in different environments (both hot and cold environments)?

Question 2: For periodic remapping, what are good acceptance criteria for changing a monitoring probe’s location?

Your Best Shot at creating a Worst Case Plus... Temperature Probe Relocation Know-how

Paul writes:
In temperature mapping, worst case depends on the use.  For a refrigerator, it could be the hottest or the coldest point (or both).  If the refrigerator is used for storing vaccines, cold is worse than hot.  For an oven, it depends on your criteria.  If you are depyrogenating, the worst case would be the cold spot. But your material might have an upper specification as well.  In the end, we recommend that you look for both the hottest and coldest spots in any environment… the extremes tell the story. One exception is freezers, where it is usually only the hottest spot that is important.


For your second question, I admit that it that only comes up occasionally and from those with some long-term experience in mapping.  The easy answer is that you should simply move the monitoring probe to the hot spot/cold spot.  But this gets complicated in two ways: first, most people don’t actually monitor the hot spot/ cold spot … they monitor an area on the wall that is representative of the hot spot/cold spot.  Second, if you find a different hot or cold spot during your remapping, it implies something has changed in the system.  

Simply provide the data that shows that there is a better place for the new probe location.

At this point you may need to go back to your historical mapping data to show that it is not unusual for this unit to have a new hot spot – likely the new hot spot would have been the second hottest spot in the old mapping study.  I wouldn’t worry about it too much unless your QA department gives you a lot of push-back.  Simply provide the data that shows that there is a better place for the new probe location. And be prepared for QA to ask for your help to show that no problems might have gone unnoticed by having the probe in the wrong location.


Thanks for reaching out and please let us know if you have further questions!
Paul Daniel

[email protected]

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Author

Paul Daniel

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.

Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.