SOP for Calibration of Balance in Pharma : Pharmaceutical Guidelines

SOP for Calibration of Balance in Pharma

Standard operating procedure to calibrate the balance used in Pharmaceutical.

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable for balance installed in quality control laboratory.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Operate the instrument as per respective Standard Operating Procedure.
5.2 Switch ‘ON’ the balance.
5.3 Press ‘ON/OFF’ key.
5.4 ‘0.0000 g' will be displayed.

5.5 For Internal calibration

5.5.1 Press the bar till ‘CAL----’ appear.
5.5.2 After few seconds ‘CAL 100’ will appear and 100 will flickers.
5.5.3 Push the ‘CAL’ key printed at the right side of balance from forward to backward position.
5.5.4 ‘100 .0000’ will appear.
5.5.5 ‘CAL 0' display will flicker.
5.5.6 Pull the ‘CAL’ key from backward to forward position.
5.5.7 ‘0.0000’ will appear.

5.6 For Accuracy

5.6.1 Place 500 mg. on the weighing pan.
5.6.2 Note the weight.
5.6.3 Calculate the difference between the weight in the certificate and observed weight.
5.6.4 Repeat the above steps using 5gm & 100 gm. weights.
5.6.5 Record the reading in Annexure-V.

5.7 For precision

5.7.1 Place 500 mg. in the weighing pan.
5.7.2 Note the weight.
5.7.3 Repeat the above two steps nine times.
5.7.4 Record the weight.
5.8 Calculate the standard deviation through the computer.
5.9 Calculate the measurement uncertainty using following equation.
                          2 x SD
= ----------------------------------------------
       Actual weight from the certificate

Limit: NMT 0.10%

5.10 Corner Accuracy Test :

5.10.1 Place 500 mg Weight in the left side of the weighing pan, note the weight repeat it three times. Calculate the difference between the measured weight and weight in the certificate.
5.10.2 Repeat the procedure by placing the weight on the right side, front side & rear side.
5.10.3 Record the results.

Related: Drift and Its Importance in Analytical Balances

5.11 Frequency

1.Internal calibration and accuracy: Daily
2 Precision and Corner Accuracy Test: Once in a month
5.12 Record the calibration details and conclusion.

6.0 ABBREVIATIONS

6.1 SD = Standard deviation
6.2 gm. = Gram

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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