Kaye Validator 2000 calibration verification fails

12 Type T Thermocouple
Validator 2000
LTR-140 Drywell
Temp range calibration 90C, 130C and check point 121C
Validating Autoclave

Calibration passes and autoclave qualification run passs but after I put thermocouple back in LTR it fails verification…any one know where to point gun at? I have changed 3 TC and SIM already. Earlier different TC will fail calibration as well. GE people never returned call.:confused:

We also use Validator 2000 system, but never had failed verfication (HTR-400 drywell). Only when thermocouples were mechanically damaged - but normally it could be a few sensors, not every sensor. Could it be a situation, that some of your thermocouples systematically damaged during sterilization cycles?

Also I have another question, concerning calibration and verification process, that utilizes GE Kaye Validator 2000. We must perform a TC calibration prior to qualification measurements according to ISO 17665 clause 9.1.4. Is it necessary to perform verification immidiately after qualification measurements to prove the calibration validity? Because accordnig ISO 17665 clause 9.1.4 verfication doesn’t insist on verification immidiately after testing.

What the regulatory requirement (guidances, standards) apply GE Kaye, providing verification possibility? Does it mean that initial TC calibration is obligatory, then, prior to next qualification we have two possbility - either to perform simplified verification (one point instead od three) without corrections, or, if verification failed (i.e. tolerances aren’t satisfactory), to perform calibartion in order to make correction for ech TC individually depending on detemined mistake.

Could somebody to clarify this question or provide a link to normative documents?