_ Procedure for Leak Testing of Strips _ Blisters

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FRIDAY, OCTOBER 31, 2008

Procedure for Leak testing of strips /

blisters

1.0 OBJECTIVE

To lay down a procedure for leak testing of strips / blisters.

2.0 SCOPE

All packing areas.

3.0 RESPONSIBILITY

Production officer.

4.0 ACCOUNTABILITY

Production executive

5.0 PROCEDURE

5.1 Take the required number of strips / blisters as mentioned

in the Annexure – I. Check the quality of strips/ blisters for any

damages.

5.2 Tie the collected strips / blisters with a rubber band.

5.3 Ensure that all strips / blisters are dipped in water and close

the lid.

5.4 Connect opening of the desiccator to the vacuum pump.

5.5 Apply a vacuum of 300 mm of Hg and close the knob of the

desiccator.

5.6 Keep the vacuum for 30sec.

5.7 Release the vacuum by opening the knob of the desiccator

slowly and open the lid remove the strips / blisters.

5.8 Wipe out the traces of water from the strips / blisters by

using lint free duster .

5.9 Open the pocket of strips by using scissors to remove the

tablets / capsules.

5.10 Open the blisters manually.

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5.11 Check for any traces of water inside the strips / blisters.

5.12 Number of tablets or capsules, which have become wet,

should not be more than 1%. If the leakage is more than the

above percentage repeat the leak test.

5.13 Record it in the respective batch packing record, with

signature and date.

ANNEXURE -I

Note:

1. Perform leak test at the starting of blistering / strip sealing,

operation.

2. If there is machine break down more than 1/2 hour perform

leak test immediately after starting the operation.

3. Whenever leakage observed during leak test, ensure that

rectification is done.

4. If leak test failure is occurring repeatedly, bring to the notice

of Executive / Sr. Executive for corrective action.at 8:05 PM

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vicky said...

But mention about the amount of water to be

taken,also.

November 3, 2008 11:55 AM

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_ Procedure for Leak Testing of Strips _ Blisters