SOP FOR LEAK TEST
Objective: To describe the Procedure for Performing a leak test during packing
Scope: This SOP applies to the Production and QA departments.
Responsibility:
- Production and IPQA Personnel shall be responsible for Performing the leak test.
- Head Quality Assurance shall be responsible for ensuring compliance with SOP.
Procedure:
- Collect the Tablet strips from the blister Packing machine that cover one complete sealing cycle.
- Then place the strips in the desiccator of the leak test apparatus filled with water and a few drops of methylene blue indicator.
- Place the perforated lid over the blisters to prevent floating and then place the lid of the desiccator.
- Then turn on the vacuum and it takes around 4-5 minutes to build up and release the vacuum.
- Adjust the vacuum according to the regulatory requirements.
- Then remove the strips and check for any leakage in the blisters by wiping them off with a free cloth and de-blistering all the strips.
- If blue color spots or water are present in the pockets and tablets stick to the pockets, then the leak test fails.
- Inform the QA and Production head if leak tests fail check the sealing temperature and investigate the issue.
- All the de-foiled tablets should be discarded in the reject bin.
- Record the observations in the batch record.
Frequency: shall be performed every 4 hours and IPQA person shall perform in-process once in a shift.