SOP for Calibration of Balance : Pharmaceutical Guidelines

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

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

   Weight box Id.No.:__________________

   For Precision
Theoretical
Weight
Actual weight from
Certificates
Observed weight
Measurement
uncertainty
Tolerance
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:
Date
Internal
calibration
Observed
wt for 5gm
Difference
Observed
wt for 50gm
Difference
Observed
wt for 100gm
Difference
Calibrated
by.

Checked
by







































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 pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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8 comments: Post Yours! Read Comment Policy ▼

  1. can say for minimum weight selection for calculation of measurement of uncertanity

    ReplyDelete
  2. i m satisfied from the sops. as well as appreciates

    ReplyDelete
  3. Sir Calibration done on the basis of Theoretical wt. or actual certified wt. Please suggest

    ReplyDelete
  4. Obviously with actual weights.

    ReplyDelete
  5. Dear Sir
    Thanks for suggestion but Sir we will calibrate every year our weight stone and every year certified actual weight changed from standard weight. (i.e. 5 kg standard weight but in certificate it shows 4.997 kg or 4.999 kg, in this condition we changed every year log book & sop balance calibration & verification format due to change in wt ( In certificate by different Party )

    ReplyDelete
  6. Sir I am not meeted with uncertainty 0.001 as per guidlence please suggest me.

    ReplyDelete
  7. Dear Sir,
    Thanks for the SOP. Please suggest the procedure to fix the acceptance criteria of Intermediate checking of balance and any standard reference of the same.

    ReplyDelete
  8. dear Sir,
    calibration of balance done on monthly basis while verification performed on daily basis.

    ReplyDelete

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