23/11/2021, 13:36 SOP for Calibration of Balance : Pharmaceutical Guidelines

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SOP for Calibration of Balance

Standard operating procedure to evaluate the performance of Analytical Balance used for the analysis in pharmaceutical quality control by accuracy and precision tests.

1.0 OBJECTIVE
To calibrate the equipment for reliable and accurate results.

2.0 SCOPE
This procedure is applicable for balance installed in the quality control department.
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 instrument.

5.3 Switch ‘ON’ the balance.

5.4 The display will blink with 8.8.8.8.8.8.

5.5 After few seconds, the display will show 0.00 g.

5.6 If display is not stable, press the TARE key & wait till the display shows 0.00 g.

5.7 Perform internal calibration and in Annexure-II

5.6 For Accuracy

5.6.1 Place 5 gm. on the weighing pan.

5.6.2 Note the weight.

5.6.3 Calculate the difference between the weight in certificate and observed weight.

5.6.4 Repeat the above steps using 50gm & 100 gm. weights.

5.6.5 Record the reading in Annexure-II.

Related: Drift and Its Importance in Analytical Balances

5.7 For precision

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23/11/2021, 13:36 SOP for Calibration of Balance : Pharmaceutical Guidelines

5.7.1 Place 5 gm. 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 in Anenxure-I .

5.8 Calculate the Standard deviation.

5.9 Calculate the measurement uncertainty using following equation.

                                                                               2 X SD
                 Measurement uncertainty =    ------------------------------------
                                                                 Actual weight from certificate

5.10 Frequency
Internal calibration and accuracy = Daily

Precision: Once in a month

6.0 ABBREVIATIONS
6.1 SD= Standard deviation

6.2 gm.= Gram

ANNEXURE-I
QUALITY CONTROL LABORATORY
CALIBRATION REPORT

OF  BALANCE
CALIBRATION DATE DATE OF LAST CALIBRATION DONE NEXT DUE FOR

CALIBRATION

INSTRUMENT DETAILS
INSTRUMENT NAME INSTRUMENT MAKE INSTRUMENT
IDENTIFICATION NO.

OBSERVATION

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23/11/2021, 13:36 SOP for Calibration of Balance : Pharmaceutical Guidelines

   Weight box Id.No.:__________________

   For Precision
Theoretical Actual weight from Observed weight Measurement Tolerance
Weight Certificates uncertainty
5gm.

Not more than 0.10

                                                  SD:

ANNEXURE-II
Q. C. DEPARTMENT
DAILY CALIBRATION RECORD
NAME OF  THE INSTRUMENT    :  BALANCE
MAKE                                                :  ADAIR DUTT
MODEL  NO                                     :  AD-180                                 
IDENTIFICATION NO.                   :
Weight box Id.No.:________________
Accuracy:
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Date Internal Observed Difference Observed Difference Observed Difference Calibrated Checked
calibration wt for 5gm wt for 50gm wt for by. by
100gm

Limit :
No. Theoretical weight Actual weights from certificates Tolerance
1 5 gm.
+/- 5mg
2 50.0 gm.
+/- 5mg
3 100.0gm.
+/- 5mg

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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