BOD IncubtorIQ/OQ - Qualification

Dear Sir/ Madam,

We have procured BOD Incubator one year back and the warranty of the Instument and validity of the certificates for PT100 sensor, Temperature controller & thermostat got expired. we started IQ, OQ after one year and supplier told that calibration of the sensors & controller can be performed during the start of PQ study, but we disagreed for that because there is a test called temperature stabilisation study & Thermostat safety cutoff study. PL suggest is it acceptable?.

This is not acceptable. It is better to calibrate all the temperature sensors and controller on current date and then proceed for qualification activity.

You should qualify and calibrate all temperature sensors before you perform a PQ phase.
You can add a checklist before PQ phase and attach to PQ document. This list should let you know about the date and details regarding calibration of the thermostats or sensors.

Dear Sir, Already we completed IQ, OQ, but yet to start PQ, before PQ we are calibrating the it OK.

Thanks sir