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

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
QCE_B	Quality control equipment calibration
F	Format