SOP on Operating procedure for leak test apparatus in pharmaceutical company

December 12, 2016August 28, 2020 Pharma Editor

OBJECTIVE
To lay down a procedure for Operation of Leak Test Apparatus

SCOPE
This Standard Operating Procedure (SOP) is applicable to In-process samples.
RESPONSIBILITY
IPQA / Production Executive / Officer
ACCOUNTABILITY
Head –Quality Assurance

PROCEDURE

Ensure that the leak test apparatus is clean.

Check that the desiccator is clean, if need be clean the dessicator with water and dry cloth.

Open the polycarbonate jars and fills the Dessicator with sufficient amount of water so that strips get submerged in the water.

Remove the O-ring, clean both tube and the groove with the help of soft dry cloth to remove any kind of dust particles & fix it back on the groove provided.

Submerge the strip or blister to be tested for leak test and place the resting plate into the dessicator and close the jar tightly.

Ensure that the vent plug is tightly closed and set the timer to one minute.

Now switch ON the mains supply.

Apply gentle force from top so that the vacuum starts developing within 30-45 seconds, which will be indicated on the vacuum gauge fixed at the top of the unit.

After getting a pressure of 380mm of Hg on the gauge, close the isolation valve. Lift the lid so as to ensure that vacuum is developing inside the dessicator.

After the set time has elapsed, the vacuum pump will automatically be switched off.

Switch off the mains switch.

The vacuum is maintained inside the jar till manually it has been released.

After this time has elapsed, remove the vent plug to release the vacuum.

Open the jar only after confirming that vacuum gauge shows zero.

Remove the Strips / Blisters.

Wipe the strip/ blister with the help of soft tissue paper in order to remove water droplets.

Visually observe the strips/ blisters for any water seepage inside. If seepage is observed, it indicates the failure of leak test.

Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History

Date Revision Number Reason for Revision

– 00 New SOP

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