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SOP for Sealing/Leakage Test

PURPOSE
It is established for sealing/leakage Tests.

SCOPE
It is applicable to QA Department.

RESPONSIBILITIES
Manager Quality Assurance.
Assistant Manager Quality Assurance.
Quality Assurance Officer.
Quality assurance assistants.

PROCEDURE

SEALING/LEAKAGE TEST
  • Collect 3 strips in case of Tablet & 6 Sachets in case of powder for sealing test with regular intervals as & when required.
  • Fill glass desiccators with water properly.
  • Add 2-3 drops of Methylene Blue to the Vacuum desiccator’s water.
  • Immerse the strips/Sachets properly in the desiccator’s water. In such a way that vacuum desiccators containing enough water to cover the sample with at least one inch of water from the top surface.
  • Cover the strips/sachets with the grid.
  • Apply the vacuum for 3 minutes/ or -600 mm of Hg for the sachet & -400 mm of Hg for Tablet or Capsule strips.
  • Release the pressure slowly.
  • Wipe off droplets over sachets, and strip whatever the case with tissue or soft cloth till complete dryness.
  • If any strip/ sachet whatever the case is shows evidence of leakage (a sign of blue coloring of the sample) reject the sample and inform the Incharge Pharmacist so that corrective action may be taken.
  • Enter this in the In-process register of the sealing record register.

CLEANING PROCEDURE FOR VACUUM DESICCATOR
  • Switch off the main electric supply of the apparatus.
  • Clean Instruments inside & outside with a clean cloth.
  • Wipe off the surrounding water.
  • Change the water regularly.

RECORD REQUIRED
The following record shall be generated and managed in accordance with the procedure for control of company quality records:
  1. Required Record Form Reference No.
  2. Sealing/Leakage test Log book

REVISION HISTORY
Nil

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