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.