Monday , September 25 2023

SOP on Operating procedure for leak test apparatus in pharmaceutical company

  • To lay down a procedure for Operation of Leak Test Apparatus
  • This Standard Operating Procedure (SOP) is applicable to In-process samples.
  • IPQA / Production Executive / Officer
  • Head –Quality Assurance
  • 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
  • History
    Date Revision Number Reason for Revision
    00 New SOP

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