STANDARD OPERATING PROCEDURE Title: “Sealing/Leakage Test”

1. PURPOSE
It is established for sealing / leakage Test.
2. SCOPE
It is applicable to QA Department.
3. RESPONSIBILITIES
3.1 Manager Quality Assurance.
3.2 Assistant Manager Quality Assurance.
3.2 Quality Assurance Officer.
3.3 Quality assurance assistants.
4 PROCEDURE
“SEALING/LEAKAGE TEST”
1. Collect 3 strips in case of Tablet & 6 Sachets in case of powder for sealing test with regular intervals as & when required.
2. Fill glass desiccators with water properly.
3. Add 2-3 drops of Methylene Blue in Vacuum desiccator’s water.
4. Immerse the strips/Sachets properly in 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 top surface.
5. Cover the strips/sachets with grid.
6. Apply the vacuum for 3 minutes/ or -600 mm of Hg for sachet & -400 mm of Hg for Tablet or Capsule strips.
7. Release the pressure slowly.
8. Wipe off droplets over sachets, strips whatever the case with tissue or soft cloth till complete dryness.
9. If any strip/ sachet whatever the case is shows evidence of leakage (sign of blue coloring of sample) reject the sample, inform Incharge Pharmacist so that corrective action may be taken.
10. Enter this in In-process register of sealing record register.
“CLEANING PROCEDURE FOR VACCUM DESICCATOR”
1. Switch off main electric supply of the apparatus.
2. Clean Instruments inside & outside with clean cloth.
3. Wipe off surrounding water.
4. Change water regularly.

5. RECORD REQUIRED:
The following record shall be generated and managed in accordance with the procedure for control of company quality records:

Required Record Form Reference No.
Sealing/Leakage test Log book