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  • 1.  Equipment Temperature Mapping

    This message was posted by a user wishing to remain anonymous
    Posted 14-Aug-2019 09:05
    This message was posted by a user wishing to remain anonymous

    ​Friends,

    What has been your experience in qualifying new refrigerators / freezers / incubators relative to temperature mapping?  Is there a minimum duration you must temperature map for?  These pieces of equipment are on a digital chart recorder / alarm system as well that sends out notice on a tiered alarm system should the temperature approach min/max alert limits.  I am hoping to get some responses for the time to temperature map if you have 10 - 12 temperature probes recording data on one minute intervals.  Thanks.


  • 2.  RE: Equipment Temperature Mapping

    Posted 15-Aug-2019 03:40
    Edited by Richard Vincins 15-Aug-2019 03:40
    Anon,

    Typically we set the duration of qualifying the temperature profile over a typical anticipated use period, generally 24 hours.  Sometimes we took them out as long as 3 days, but generally it was anywhere from 12 to 24 hours, encompassing a "work day" expected for normal operation of the storage unit.  We also generally monitored freezers during the validation qualification for a longer period of time, especially ultra-low freezers because they were generally more finicky.  Industrial grade refrigerators now are generally pretty stable.  If they are already going to be on a digital recorder / alarm system, the qualification validation can just be for a typical work day.  Depending on your product, processes, and what storage conditions are used for, we also did empty chamber profiles for 24 hours, then we did full chamber profiles for 24 hours (after letting settle once was loaded), then we did full chamber profiles in normal operation, i.e. opening and closing throughout the day, and then did the open door challenge.  The open door challenge was letting the door open till it alarmed, and then also doing open door multiple times to see the recovery curve for the storage unit.  Again depending on what you are using the storage unit, maybe 1x 24 hour full chamber normal use is ok or maybe 1x empty and 1x full is needed.  If you want a definitive answer, I like to refer to the WHO guidance document on qualification of storage units where they recommend empty profiles for at least 24 hours: https://www.who.int/biologicals/expert_committee/Supplement-7-TS-qualification-storage-areas-ECSPP-ECBS.pdf. They also recommend doing full chamber profile as well, though in practicality again depending on your storage unit one, either, or both may be needed.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Equipment Temperature Mapping

    Posted 15-Aug-2019 16:23
    Hi Anon.

    I would echo Vincent's comments.  The rule is pretty logical - test what you plan to use the system for; prove the system works as expected; monitor the system to ensure ongoing compliance with whatever you need to use the system for.

    I have been in situations where we have taken some of these validations out for 5-7 days more to mirror the idea that there might be staff limits or periods where the system is not used "daily" but where you would need to have the system prepared to be used at any time.  Again, a lot depends on just what you plan to use the system for and how often or what uses/methods you might need to have taken into account.  For example, if you have a situation where you are working to verify a system actually will alarm properly, the key issue might be the mapping of the system during an "out-of-ordinary" condition (such as unplugging or simply leaving the door open as Vincent suggested).  The key here is to understand where the system is most exposed to failure and ensuring that your alarms are assuring "worst-case" if you need something to be kept at a critical temperature.  ​Additionally, mapping should provide you with data to show where you are coldest if that might cause you any issues.  If this is something that can cause you problems, then you likely will need 2 monitoring alarms (at least) because you would need one for your "warm" spot to detect elevated temperature and one for your "cold" spot to detect any excessively depressed temperatures...

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: Equipment Temperature Mapping

    Posted 15-Aug-2019 21:46
    Hi Anon,
    I've previously had to qualify an incubator, and we ended up hiring a company to come in and do the test. If I recall correctly, it took the better part of a day to get through the testing. I believe there were 9 thermocouples (each corner, and center), though I'd imagine you may need to modify this based on the size of your unit. We had to have the incubator loaded with representative samples, and there were some tests done to see how long it took to stabilize after opening/closing the door. Although we also had alarms to alert if temperature went out of range, the issue was we weren't certain that the temperature recorded by the incubator was accurate until performing thermal mapping.

    Hope that helps!

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    Kristina Cook
    San Francisco CA
    United States
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    Original Message


  • 5.  RE: Equipment Temperature Mapping

    Posted 16-Aug-2019 11:38
    I agree with Richard's comments. Temperature Profiling is typically based on the use of the instrument, temperature maintenance (-80, -20 etc.) etc. However, typically it is done for a period of 12-24 hours. So, you could consider this as a minimum duration for your temperature mapping.

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    Loganathan Kumarasamy, MS RAC
    Senior Consultant
    Waukegan IL
    United States
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    Original Message


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