Calibration & Operation of leak test Apparatus

1.0 OBJECTIVE

1.1 To lay down the Procedure for Operation and calibration of the leak test apparatus.

2.0 SCOPE

2.1 This procedure is applicable for operation & calibration of the leak test apparatus in Quality control department at pharmaceuticals mfg Unit.

3.0 RESPONSIBILITY

3.1 Executive Quality control

4.0 ACCOUNTABILITY

4.1 Manager – Quality Control

5.0 PROCEDURE

5.1 OPERATION:

5.1.1 Take required quantity of blister/vials from sample received in Q.C. department

5.1.2 Q.C. officer shall perform leak test as procedure given below 

5.1.2.1 Ensure apparatus bath is filled with purified water up to mark indicated and add 0.5% crystal violet solution in water.

5.1.2.2 Cover the leak test chamber by using lead and place on it.

5.1.2.3 Connect the three pin plug to the main put “ON” the main instrument will glow “ON” set the time by up/down key then press the start key to process.

5.1.2.4 Any increase or decrease of the vacuum inside the container can be controlled by release value provided on the apparatus.

5.1.2.5 As soon the vacuum gauge indicates 200 mm of Hg then close the control value so that vacuum starts developing within 30-45 seconds which will be indicated on the vacuum gauge fixed at the unit.

5.1.2.6 The sample remains at the required vacuum level for given time interval buzzer will sound after time is over and it will cut off the vacuum pump.

5.1.2.7 After the test is over put “OFF” the mains and release the inside vacuum by pushing out the controlled stopper. 

5.2 CLEANING PROCEDURE:

5.2.1 Cleaning of leak test apparatus by using purified water and clean outer and inner surface with the help of lint free cloth.

5.2.2 Place the apparatus for dryness for half an hour.

5.2.3 Change the desiccator water twice in a week or as per required.

5.2.4 Affix the cleaned label with approved signature. 

5.3 CALIBRATION PROCEDURE:

5.3.1 Take calibrated stopwatch and start timer of leak test apparatus and stop watch simultaneously.

5.3.2 Note the reading at intervals of 60 second, 180 second, 300 seconds respectively.

5.3.3 Acceptance criteria, 10 seconds for each interval.

5.3.4 Vacuum gauge calibration done by external party.

5.3.5 Frequency of calibration: Twelve months (for timer, vacuum gauge and vacuum holding capacity).

5.4 HITORY OF REVIEW: 

DATE	SUPERSEDES	CCF No

6.0 ABBREVIATIONS:

6.1 SD – Standard Deviation.

6.2 SOP-Standard Operating Procedure

6.3 Q.A. – Quality Assurance

6.4 No. – Number

6.5 NA – Not Applicable

6.6 CCF – Change Control

6.7 QC – Quality Control

7.0  ANNEXURES:

7.1  Annexure-I      Daily calibration record of Analytical balance.

7.2  Annexure – II   Monthly calibration record of Analytical Balance.

CHANGE HISTORY
Supersedes SOP No.	Change Control No.	Changes made
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