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Equipment Qualification: CO2 Incubators

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Metrologist, Dec 3, 2016.

  1. Metrologist

    Metrologist New Member

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    Our Metrology department performs the equipment qualifications in addition to the calibrations.
    Currently our CO2 incubators are qualified at 37 Degrees and 5% CO2. continuous changes by the user is now required.
    What is required to maintain control and still allow the processes to continue?

    An example of change is to set the incubator to 36 Degrees 8% followed by 32.5 degrees at 0% and 38 degrees with 2% CO2 . Several other points may also be required. All of this is scheduled to occur over about a week to 10 days. Currently we issue a change Control and perform calibrations and full qualifications(empty ,loaded, open door, power failure) for each set point change.

    This seems extreme and causes up to a month of process halt until the change control and the new qualification documents are signed by QA. in my 30 years of performing these tests we have not had a single failure that was temperature or CO2 related. This causes my question of why do we do this?
    There must be a logical and more cost effective way to change a set point of an incubator and still remain compliant to GMP and FDA regulations. I welcome any suggestions as i cannot find any detailed regulations requiring these actions.
     

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