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SOP on Operation, cleaning of Leak test apparatus

Purpose: To let down the standard operating procedures for operation cleaning and calibration of the Leak test apparatus.

Scope: This standard operating procedure is applicable for operation cleaning and calibration of leak test Apparatus in IPQC at the plant.

Responsibility :

The production officer or officer is responsible for operation cleaning and calibration of leak test apparatus.

Head Quality Assurance and Head Production are responsible for ensuring compliance with the standard operating procedure.

The engineering officer is responsible for the calibration of leak test apparatus operators for vacuum gauge and timer.

Pre-operation checks:

  • Check that the leak test apparatus is calibrated
  • Ensure that no blister strips container of Previous test check are lying in the leak test operators
  • Check the blister /strip container taken for leak test for any physical damage before performing the test
  • Check that the methylene blue solution is prepared.

Procedure:

Preparation of methylene blue solution:

  • Remove the lead and disc placed inside of the desiccator. Take soft water in the desiccator up to the level of the disc.
  • Add 0.5 % v/v solution of methylene blue indicator for example 20 ml in 4000 ml water.
  • This solution shall be changed every working day.

Procedure for performing leak test for strip and blister:

  • Collect the blister/strips from the strip/blister machine such that all pockets of the Counter selling roller for sealing roller are covered.
  • Place the blister or strips in leak test operators immersed in methylene blue solution with the help of the disc provided with the Leak test apparatus.
  • Place the lid properly using a rubber gasket and ensure that it is Sealed.
  • Switch on the main power supply to leak test Apparatus then LCD screen show 000 mm Hg and time show 00.00 vacuum and time can be set by pushing the key of set vacuum and time.
  • Press start key given on leak test apparatus LED light will be on and the LCD screen we show the releasing vacuum and time 00: 03 00:00 minutes .then vacuum pump of leak test Apparatus will start, and the LCD screen will show the increase in vacuum pressure when the vacuum reaches up to level then vacuum pump stop automatically and the LCD screen show vacuum 280±10 mm mm Hg and hold time 02:00 minutes to 00:00 and LCD screen show releasing vacuum and time 01:00 minutes 00:00 minutes and a red light will stop.
  • Open the lid of the Apparatus and take open the lead of Apparatus and take out blisters or strips from the solution.
  • After removing the blister and strip, wipe them dry individually with the help of a lint-free Duster.
  • Open each blister and strip and check tablets visually for damage due to leakage for Spot with methylene blue indicator color.
  • After the leak test, discard the packaging material in the waste Bin and transfer the Tablet to a container bearing the label container waste for disposal at the end of the shift transfer the product waste container to the washroom.
  • Tablet failing in the test should not be packed.

Permissible limits:

No Stains of methylene blue solution should be observed on the Tablet, or none of the tablets subjected to leak test should show a wet surface.

Failure of leak test for blister or strips:

  • Stop the machine immediately and inform to Department Head.
  • Quarantine the blister packed during the interval between the last satisfactory leak test and failure of the leak test.
  • Inform to QA department by raising the division as per sop.
  • Handle the quarantine-packed finished goods as per process and mentioned in the division.

The leak test procedure for performing for the container :

  • Take one cleaned container, seal the container by means of induction cap sealer machine as per sop. “setting, operation and cleaning of induction cap sealing machine” cross mark the sealed container with permanent pen marker and put the sealed container in a polyethylene bag.
  • Remove the cap of the container and place the container without a cap in the desiccator and place the proposed disc plate above the container.
  • Put the load on a perforated disc plate with a perforated metal disc so that container remains dipped in solution. Close the lid of the desiccator properly by adjusting the alignment of the rubber gasket and ensure that it is sealed.
  • Place the lid properly using a rubber gasket and ensure that it is Sealed.
  • Switch on the main power supply to leak test Apparatus then LCD screen show 000 mm Hg and time show 00.00 vacuum and time can be set by pushing the key of set vacuum and time.
  • Follow the above process to start the Apparatus.
  • Open the lid of the Apparatus and take out the aluminum triplex eliminated polybag from the solution.
  • After removing aluminum triplex, laminated polybags wipe them to dry and usually with the help of a lint-free Duster.
  • Open the aluminum triplex laminated poly bag and check tablets visually for damage due to leakage or Sport with methylene blue indicator color.
  • After the leak test of the aluminum triplex, laminated polybag, discard the packaging material in the waste Bin and transfer the Tablet to a container bearing the label “container waste for disposal.” at the end of Shift, transfer the product waste container in the washroom.

Frequency :

Leak test for aluminum triplex laminated polybag will be done jointly by production and quality assurance at the start of the batch, after any breakdown maintenance of the machine and end of the batch.

Failures only test for the bulk pack :

Failure of the leak test will be handled by raising the division by production as per sop” handling of division. “

Challenge test :

  • Perform a challenge test for leak test Apparatus after performing the first leak test every day or when you require it.
  • Collect five blisters or strips randomly for the challenge test. In the case of container packing, take one empty bottle for a challenge test.
  • Puncture the blister or strip at one end on a pocket by a wire and mark the same by permanent Marker Pen.
  • In the case of a container, packing removes the cap of the bottle, punctures the seal of a bottle with the help of the wire, and marks the same with a permanent marker.
  • Operate and perform the leak test as follow the procedure defined in the step above.

Permissible limit:

  • Only puncture blister/ strip and the container should be failled in leak test.
  • If there is no penetration of dye solution in the puncture blister /strip container pocket, this indicates that there is no sufficient vacuum created inside the leak test apparatus.

Cleaning of leak test apparatus :

  • Clean the leak test Apparatus externally after every test with a clean lint-free Duster.
  • Discard the methylene blue solution in a container transfer the container to the washing room.
  • Dilute methylene blue solution with an ample amount of water and drain.
  • Clean the leak test Apparatus desiccator along with the vacuum pump pipe with soft water after every working day.

Calibration Of leak test apparatus:

Calibration of leak test Apparatus for vacuum gauge will be done on a yearly basis, and for timer will be done on a half-yearly basis.

Related Post: calibration of weighing balance

Abbreviation:

  • SOP- the standard operating procedure
  • IPQC- in-process quality control
  • LCD -liquid crystal display
  • Hg-Mercury
  • MI-millimetre
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