RE: Calibration of scales during filling of sterile product Contribution from JD Mallet written on 8/22/2010 at 14:13
Original contribution: Calibration of scales during filling of sterile product written by SN on 8/21/2010 at 10:40) Dear SN,
I am not so familiar with calibration of scale at such a frequence. I guess the scale is to automatically measure and deliver the expected amount of product in each vial, is that right ?
Of course, if so, this is a critial application (filling right volume of solution or right weight of powder) but I am a little bit surprised with the 15 minutes calibration time.
Is this a valuable practice ? Or the scales are stable and there no drift and so the calibration time could (should) be extended or they are not and so the filling is a non-controlled operation.
What is the point in the process ? Right volume/weight delivered or right sterility assurance level ? The more often you will calibrate the scale(s) and the highest will be the risk of particulate/microbiological contamination of vials.
Last, if the weight is not driving the filling process (monitoring only), so it is not critical and consequently I would recommend you not to calibrate the scale(s) during the filling operations.
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