1.0 OBJECTIVE:To lay down the procedure for leak test of strip, blister and alu – alu blister sealing.
2.0 SCOPE:This SOP shall be applicable to Production and Quality Assurance Dept.
3.0 RESPONSIBILITY:Supervisor Production/Supervisor Q.A
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 Perform the leak test at an interval of about two hours.
5.2 Collect strips from packing machine according to number of pockets present in the forming roller.
5.3 Tie the bunch of strips with rubber band put them in a vacuum desiccator.
5.4 Fill 1/3 of the volume of the vacuum desiccator with water and add a few drops of methylene blue and mix it to give a light blue colour.
5.5 Place the strips in the desiccator and ensure that they are completely immersed in water.
5.6 Connect the rubber tubing of the vacuum pump to the side opening of the sleeve.
5.7 Switch on the mains of vacuum pump and apply vacuum for 30 seconds on 15 inches of Hg pressure (negative pressure)
5.8 Move the side-opening knob to ensure vacuum and remove the rubber tubing from the sleeve.
5.9 Gradually release the vacuum and remove the strips from water after 3 minutes.
5.10 Observe the pockets for Leakage and Count the number of pockets leaked and calculate the % of pockets leaked with the following equation:
No. of Pockets leaked x 100
Total No. of Pockets
5.11 Record the findings in the batch manufacturing record and advise to packing department accordingly.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
6.5 Hg : Mercury
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips. Email: email@example.com.
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