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cGMP and Regulatory UpdatesThis Blog is created for the updation of knowledge on current Good Manufacturing Practices (cGMP) and currentUpdates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs) for anyPharma plant.
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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