SOP for Leak Seal Test Apparatus : Pharmaceutical Guidelines

SOP for Leak Seal Test Apparatus

Standard operating procedure to operate the leak test apparatus and testing of strips or leakage using the methylene blue.

1.0 OBJECTIVE

To lay down the procedure for operating leak seal test apparatus.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Supervisor Q.C

4.0 ACCOUNTABILITY

Head- Quality Assurance

5.0 PROCEDURE

5.1 Ensure the cleanliness of the area and the equipment.
5.2 Ensure that there shall not be any remnants of previous product handled in the instrument.
5.3 Fill the desiccator with water just below the level of the sieve, add few drops of methylene blue and mix to give a light blue color.
5.4 The number of strips/blister taken should be sufficient to cover all the pockets of sealing roller.
5.5 Take the exact number of strips/blisters and dip them into the water in the desiccator.
5.6 Place the plastic sieve over the strips and place the lid over the desiccator.
5.7 Connect the desiccator to the vacuum pump.
5.8 Switch ‘ON’ the vacuum pump.
5.9 Apply 15 inches of Hg pressure (negative pressure), Hold the vacuum for 2 minutes after the desired pressure is reached.
5.10 Switch ‘OFF’ the vacuum pump.
5.11 Release the pressure slowly (taking at least 30 seconds) and take out the strips.
5.12 Wipe them to dry with a clean dry lint-free cloth.
5.13 Defoil the strips/blisters and observe for blue spots/moistness/water inside
5.14 If blue spots/ moistness or water is found inside the pockets, strips are failing in the test. Inform the results of the test to Q.A Person for necessary action.
5.15 Take care to discard all tested tablets/Capsules by putting in a container filled with water.
5.16 Q.C Dept. should perform the test for all the Finished Product batches received from Production dept.

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

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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.
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