Leak test apparatus Calibration SOP


1.0  OBJECTIVE:
To lay down the calibration procedure of Leak test apparatus.
2.0  SCOPE:
This shall be applicable to the Leak test apparatus of Quality Control Instrument Laboratory.
3.0  RESPONSIBILITY:
3.1  Technical Assistant/ Helper.
3.2  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Manager-Quality Control.
4.2  Head of the Q.C Department.
5.0  MATERIAL AND EQUIPMENT:
5.1  Leak test apparatus.
5.2  Stop watch.
5.3  Sample (blisters/ strips).
6.0  PROCEDURE:
6.1  Switch ON the mains.
6.2  Operate the leak test apparatus according to SOP
6.3  Take calibrated stop watch and start timer of leak test apparatus and stop watch simultaneously.
6.4  Note the reading at intervals of 60 seconds, 180 seconds & 300 seconds respectively.
6.5  Acceptance criteria:
6.5.1        10 seconds for each interval.
6.6  Vacuum gauge calibration is done by external party.
6.7  Frequency:
6.7.1        12 months (for timer, vacuum gauge & vacuum holding capacity).


7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

8.0  REFERENCES:
8.1  Not Applicable.
9.0  ANNEXURES:
Annexure 1: Calibration record of Leak test apparatus.




















Annexure: 1
Calibration record of Leak test apparatus
CALIBRATION RECORD OF LEAK TEST APPARATUS
Calibration date
Date of last calibration done
Next due for calibration



INSTRUMENT DETAILS:
Name of equipment 
Frequency
Leak test apparatus
Yearly

Sr. #
Time
Readings
Remarks

60sec



180sec



300sec









Conclusion: Satisfactory/ Not satisfactory.

Calibrated by/date
Checked by/date




10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
Q.A
Quality assurance
QCEB
Quality control equipment calibration
F
Format


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