SOP for Operation and Calibration of Leak Test Apparatus : Pharmaguideline -->

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SOP for Operation and Calibration of Leak Test Apparatus

Standard operating procedure and calibration of Leak Test Apparatus used in analysis of tablets blisters and injection vials as per USP.


To lay down the procedure for operation and calibration of leak test apparatus.


This SOP is applicable for operation and calibration of leak test apparatus.


Officer/ Executive - Quality Control


Manager - Quality Control


5.1 Operating procedure for LT-101 Apparatus

5.1.1 Take required quantity of blisters/vials from the sample received in QC department.
5.1.2 QC officer shall perform leak test as procedure given below. Ensure apparatus bath is filled with purified water up to mark indicated and add 0.5% crystal violet solution in water. Cover the leak test chamber by using lead and place on it Connect the three pin plug to the mains put “ON” the main instrument will glow “ON” set the timer by up/down key then press the start key to the process. Any increase or decrease of the vacuum inside the container can be controlled by release value provided on the apparatus. 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. 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. 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 the lint-free cloth.
5.2.2 Place the apparatus for dryness for half an hour.
5.2.3 Change the decicator 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 a calibrated stopwatch and start timer of leak test apparatus and stopwatch simultaneously.
5.3.2 Note the reading at intervals of 60 seconds, 180 seconds, 300 seconds respectively
5.3.3 Acceptance criteria: 10 seconds for each interval.
5.3.4 Vacuum gauge calibration done by the external party.
5.4 Frequency of calibration: Twelve months (for the timer, vacuum gauge and vacuum holding capacity).


6.1 SOP - Standard Operating Procedure
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