Regulatory Open Forum

 View Only
  • 1.  Qualifying Temperature Controlled Equipment

    This message was posted by a user wishing to remain anonymous
    Posted 16-Aug-2019 11:42
    This message was posted by a user wishing to remain anonymous

    ​Members,

    I would like to get input into any "standards" or "regulations" in qualifying temperature controlled equipment (freezers, refrigerators, incubators, etc...).  Some of these are hooked up to a monitoring system which alerts personnel once they reached a temperature defined on a 3 tier alarm system.  When qualifying these, is there a minimum "standard" as far as conducting temperature mapping?  How long should you temperature map for?  24 hours? 12 hours? 8 hours?  We currently perform a 24 hour temperature mapping.  Can this be shortened?

    I should note, that 10 -12 temperature probes are used, with each probe collecting data on one minute intervals.

    Any input would be greatly appreciated. 

    Thanks.


  • 2.  RE: Qualifying Temperature Controlled Equipment

    Posted 16-Aug-2019 14:33
    I believe this a repeating question as I see another thread with a similar question and the response. Please refer to that thread.

    ------------------------------
    Loganathan Kumarasamy, MS RAC
    Senior Consultant
    Waukegan IL
    United States
    ------------------------------