SOP for Procedure for Checking Leak Test

OBJECTIVE

To lay down a procedure for checking leak test.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities of XYZ Limited, Formulation division.

RESPONSIBILITY

The production staff and QA Supervisor are responsible for the implementation of the process.

The production In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

• The requisite number of strips equivalent to completing one roller round are randomly collected from the packing machine at the beginning of production and every after intervals of 4 hours.
• The strips are then immersed in desiccators, half filled with colored water (dissolve methylene blue in water) for easy detection of any leaks. Place the disc over the strips to prevent them from floating.
• Cover the desiccators with the lid.

• Attach one end of the rubber tubing to the lid of the desiccators and the other end to a vacuum of 15 Lb per sq.inch. (400mm of mercury) is obtained. Close the stop cock of the desiccators. Maintain the vacuum inside the desiccators for 30 sec. to Blister Pack or 60 sec. to Strip Pack then switch off the pump.
• Gradually open the stop cock to allow air to enter the desiccators until equilibrium is attained. Allow the Strip to remain for 90 seconds. More in the desiccators.

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• Remove the Strip from the desiccators; wipe the water with a clean and dry cloth.
• Cut open the Strip. Check the most tablets or capsules and calculate the percentage of leakage.
• Tablets, capsules, or bottles pass the test if there is no leakage on the strip or bottle.

• If tablets/Capsules/bottles fail in Leak Test ask the operator to increase the pressure on the roller or reset the machine and then with a fresh sample repeat steps 2 to 7.
• Record every entry in B.M.R.
• All in-process tablets checked for leak test should be destroyed by pouring them into a container that contains water.

REFERENCE

Nil.

ABBREVIATION

Q.A: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

P.D: Production

B.M.R: Batch manufacturing record

ANNEXURE

Nil.

REVISION HISTORY

Nil.

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