Leak test of packed materials

1.0 OBJECTIVE

To provide a procedure for determining the Leak test of packed material.

2.0 SCOPE

This SOP covers the Leak test of packed material.

3.0 RESPONSIBILITY

Production Chemist

4.0 ACCOUNTABILITY

Production Manager

5.0     PROCEDURE:-

5.1     LEAK TEST FOR BLISTER/ STRIP

5.1.1   Take desired number of strips in such a fashion so they cover all cavities / pockets.

5.1.2   Samples to be collected from machine at the time of start up then at interval of 4 hours and when roll is changed.

5.1.3   Place the sample in jar containing enough water to cover the sample at least one inch of water (Measured from the top surface of package). Use a metal grid or screen to hold the sample submerged.

5.1.4   Close the jar and slowly apply 15 inch of Hg as reading on vacuum gauge hold under vacuum for 4 minutes.

5.1.5   Slowly release the vacuum and remove the sample.

5.1.6   Carefully dry the sample with tissue or cloth.

5.1.7   Examine all pockets for evidence of leakage. If leakage found, stop the process to take necessary action.

5.1.8    After adjustment of the machine, select another representative set of sample and repeat leak test. If no leakage detected, the packing may be restarted.  If leakage of any sample is still evident, adjust the machine and perform retesting until the process is demonstrated under control.

5.1.9    Record the result of all test in B.P.R.(Batch Packing Record) including time tested, the sample size the number of leaking sample found, corrective action taken and result of further testing.

Quarantine the strip produce since the previous acceptable test and after on appropriate investigation, take it as recovery.

5.2  LEAK TEST FOR DRY SYRUP BOTTLE:

5.2.1   Take bottle from sealed bottles.

5.2.2   Place bottle in jar of leak test apparatus.

5.2.3   Place the sample in jar containing enough water to cover the sample at least one inch of water. Use a metal grid or screen to hold the sample submerged.

5.2.4   Close the jar and slowly apply 15 mm of Hg as reading on vacuum gauge hold under vacuum for 2 minutes

5.2.5   Slowly release the vacuum and remove the sample.

5.2.6   Carefully dry the sample with tissue or cloth.

5.2.7   Examine bottle for penetration of water into bottle by checking wetness of content. If leakage found do necessary action. Adjust, sealing machine, repeat the procedure. Record the result in B.P.R. 

5.3 For vials (if the leakage is in vials):

5.3.1 Check, adjust the pressure on chuck and sealing rollers and repeat the test till it complies.

 If leak test fails, quarantine the shippers between the previous acceptable test and failed test collect five blisters / strips / containers / vials for leak test from each layer of the packed shipper starting from the first, and perform the leak test

5.4 Calibration of Leak test Apparatus :

5.4.1 Calibration shall be performed Once in three months or Calibration should be performed after     any maintenance job.

5.4.2 Adjust the set time to 2 minutes. Press the start button and simultaneously start the calibrated stopwatch.

5.4.3 Check the time on the stopwatch and record the observations in calibration report at the end of the test.

Acceptance Criteria:

Time on the stopwatch should be in the limit of 2 min ± 2 seconds.

If results are out of acceptance criteria, then affix “DO NOT USE-BREAKDOWN” label on the instrument.