SOP for Leak Testing of Strips/Blisters

OBJECTIVE

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

SCOPE

All packing areas.

RESPONSIBILITY

Production officer

ACCOUNTABILITY

Production executive

PROCEDURE

• Take the required number of strips / blisters as mentioned in the Annexure – I. Check the quality of strips/ blisters for any damages.
• Tie the collected strips / blisters with a rubber band.
• Ensure that all strips / blisters are dipped in water and close the lid.
• Connect opening of the desiccator to the vacuum pump.
• Apply a vacuum of 300 mm of Hg and close the knob of the desiccator.
• Keep the vacuum for 30sec.
• Release the vacuum by opening the knob of the desiccator slowly and open the lid remove the strips / blisters.

• Wipe out the traces of water from the strips / blisters by using lint free duster.
• Open the pocket of strips by using scissors to remove the tablets / capsules.
• Open the blisters manually.
• Check for any traces of water inside the strips / blisters.
• 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.
• Record it in the respective batch packing record, with signature and date.

ANNEXURE

Annexure – I: Test Report for Leak Test

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.

ABBREVIATION

Nil

REVISION HISTORY

Nil

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