Weighing Scale used in Phamaceutical Production - Daily Verification

WalkingSeed

Involved In Discussions
#1
I question came to me today regarding the daily verification of high capacity weighing scales used in phamaceutical production. This is in reference to scales with capacities of 500kg and higher. I have not seen daily verifications of high capacity weighing scales but am very familiar with the practice of performing daily / pre-use verification of analytical balances in compliance with USP <41>. Does anybody have any experience with production plants performing daily verifications of high capacity weighing scales? If so, are the checks done to capacity or some fraction of the scale capacity?
 

Ajit Basrur

Staff member
Admin
#2
I question came to me today regarding the daily verification of high capacity weighing scales used in phamaceutical production. This is in reference to scales with capacities of 500kg and higher. I have not seen daily verifications of high capacity weighing scales but am very familiar with the practice of performing daily / pre-use verification of analytical balances in compliance with USP <41>. Does anybody have any experience with production plants performing daily verifications of high capacity weighing scales? If so, are the checks done to capacity or some fraction of the scale capacity?
We had earlier discussed an identical situation here - Daily weight checks of floor scales and there are some good points described in it.

If it does not address your questions, pls come back.
 

WalkingSeed

Involved In Discussions
#3
My question is related specifically to the pharma environment. I looked at the thread you suggested and it provided no answer relevant to current practices in pharma.
 

Ajit Basrur

Staff member
Admin
#4
My question is related specifically to the pharma environment. I looked at the thread you suggested and it provided no answer relevant to current practices in pharma.
From a Pharmaceutical perspective, 21 CFR Part 211.68 (a) states -

(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.

Thus if the weighing scale under discussion contributes to the "quality" of the product, a daily verification is required in addition to the calibration at predefined intervals.
 

WalkingSeed

Involved In Discussions
#5
There is nothing in that regulation that prescribes a daily verification check unlike USP <41>. Regular calibration according to documented procedures are a routine function. I am looking for practical experience with this. Having worked for a few decades in regulated environments I am very familiar with what the law says. My question is, is anybody doing daily verifications of high capacity scales used in manufacturing and if so, how?
 
E

Edwin2

#6
I think it depends on that what task you perform these scale. Because when you use it during production, then you must calibrate it daily to get the accurate result when you using scale in a pharmaceutical industry.
 
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Edwin2

#7
Why not you use NTEP certified Scales because these scale and more accuracy and you can get accurate results with that scales even you don't calibrate them daily.
 
#8
Yes. High capacity scales do need daily weight verification. The best way to establish this is by using weights covering the range of working capacity.. Generally 50, 100 and 150% of working capacity to prove linearity.. Have seen this in multiple pharmaceutical plants.. Hope this answers your question!
 
#9
Agreed,
The Scale needs to be checked and the check must encompass the process range used by that scale.
Scale size or accuracy of the scale has no bearing on this requirement within the pharma industry. Do you know if your company adheres to USP standards?
in addition, this needs to be part of an SOP and documented. Calibration and daily checks are not the same thing. Both need to be identified within your procedures.
 

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