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RE: RE: Calibration of scales during filling of sterile product

Contribution from Ian written on 8/23/2010 at 00:46

Original contribution: RE: Calibration of scales during filling of sterile product written by JD Mallet on 8/22/2010 at 14:13)

There is a difference between calibration and validation. What you are describing sounds more like verification than calibration. Typically calibration is multipoint intensive confirmation of the accuracy and linearity across the working weight range of the scale. Calibration is done to ensure that everything within the scale is working as intended and that the scale is capable of the determining weights accurately (within manufacturers specifications).

The activity described originally isn't likely full calibration but instead verification (in my opinion), which is typically a single point verification performed online. The purpose of verifcation is to ensure that the target weight (fill weight) is correct.
Real world example: if filling to 250 grams of liquid during filling operations you would verify the accuracy of the inline scale by using a 250 gram wieght as a challenge. If the scale accurately displays 250 grams (within predefined tollerences) then the run continues. If there are variances investigations must take place.

More important than all that is this... why are in line verifications required? If your calibration program is robust enough you shouldn't need such a labor-intensive verification program.

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