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    Email: info@tritec-klima.de

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    High quality workmanship
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    Qualification

    ISO 9001 certificate
     
     
    gmp-logo

     
     
    DQ (Design Qualification)

    Definition:

    Documented proof that the quality-related, GMP-related requirements has been adequately addressed in the design of equipment, including buildings, premises and auxiliary equipment

    The user-requirement profiles (specifications) are documented and confirmed by us. On request, a specification can be created by us.

     

    IQ (Installation Qualification)

    Definition:
    Documented proof that critical equipment and systems have been delivered and installed in accordance with the set requirements and government regulations.

    The IQ documentation is worked out by us especially for the delivered machine and is made available to you.
    The IQ documentation has to be carried out by the customer itself.

     

    OQ (Operational Qualification)

    Definition:
    Documented proof that critical equipment and systems in accordance with the set requirements in the whole operating range are working as intended in accordance with predetermined limits.

    The OQ documentation is worked out by us especially for the delivered machine and is made available to you.
    The OQ documentation has to be carried out by the customer itself.

     

    CQ (Calibration Qualification)

    Definition:
    Documented proof that critical measuring equipment in the intended range in accordance with predetermined tolerances operate reliably under current operating conditions

    Checking the temperature in the cabinet
    1 Temperature on 3 different measuring points
    (measured with calibrated PT 100 sensor) evenly located on the shelves. Inspection time 6 hours, open door after that of 30 seconds. The inside temperature of the cabinet must have been stabilized itself within 1 hour on the set point temperature.
    The measurements are carried out in the empty state.
    The temperature measures are carried out in our company, represented graphically and provided to you.
    The values may not dropping below or above the tolerances given by us.

    (Additional measuring points on request)

     

    PQ (Performance-Qualification)

    Definition:        

    Documented proof that critical equipment and systems in accordance with the set requirements in the whole workspace under current working conditions (with product) provide the requested services  

    The calibration described above is carried out under real conditions on site.
    The values may not dropping below or above the tolerances given by us.