- 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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