SOP for Calibration of Bursting Strength Tester : Pharmaceutical Guidelines

SOP for Calibration of Bursting Strength Tester

Standard operating procedure to calibrate the Bursting Strength Tester with standard foil.

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to calibrate bursting strength tester.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/ Executive
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Frequency of calibration: Once in three month
5.1 Operate the instrument as per SOP
5.2 Place the standard piece of foil over the diaphragm and take the reading from the gauge.
5.3 The result should within the standard foil range. If any results differ by more than specified range limit. Follow the S.O.P.
5.4 Keep the record of calibration as per Annexure-I

Related: SOP for Bursting Strength Tester

6.0 ABBREVIATIONS

6.1 kg = Kilogram
6.2 cm. = Centimeter
6.3 S.O.P.= Standard operating procedure
6.4 No.= Number

ANNEXURE-I
QUALITY CONTROL LABORATORY
CALIBRATION REPORT OF BURSTING STRENGTH TESTER
CALIBRATION DATE

DATE OF LAST CALIBRATION DONE
NEXT DUE FOR
CALIBRATION



INSTRUMENT DETAILS
INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.




OBSERVATION


Certificate No. of Std. Foil used :  (1)                                                (2)

Sr. No.
Specified value Range of Std. Foil
Observed value
01


02










Acceptance Criteria      :  Observed value should be with in the specified range of standard foil value.                       
Remarks
Calibration date
Calibration due date
Calibrated  by
Checked by
:
:                                                                    
:
:
:





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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