SOP for Operation of Leak Test Apparatus

OBJECTIVE

To lay down a procedure for the operation of the leak test apparatus.

SCOPE

This procedure applies for the QC department in the Pharmaceutical Manufacturing Facilities of XYZ Limited.

RESPONSIBILITY

The QC analyst is responsible for the implementation of the process.

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

PROCEDURE

• Place the test sample in the desiccator, which is filled with purified water to the desired level.
• The number of test sample should be as per batch record. In case of blister/strip pack, take the corresponding sample representing the complete sealing area of the blister/strip packing machine.
• Connect the vacuum tubing between desiccator and to the vacuum inlet provided on the top of the instrument.
• Switch on the power.
• Set the vacuum 400 MM Hg by rotating ‘set vacuum knob’ provided on the top of the instrument.

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• Set the time to 2 minutes by rotating ‘set minutes’ key.
• Set vacuum will be displayed on the vacuum gauge.
• By starting the main switch, the vacuum built-up will start.
• After crossing the desired vacuum level, the timer countdown will start. Do not touch or try to remove the vacuum tube from the desiccator, as the test will not be correct then.
• The vacuum will be released manually after the completion of the time.
• Remove the test sample.
• Wipe out the water by using lint-free cloth or tissue paper.
• Open the container and observe the product. In case of blisters/strips, defoil them with dry hands and observe the tablets/capsules. If wetting is found then leak test fails.
• In case of test failure, adjust the packing setup again and repeat the test.
• Ensure that the leak test passes before commencing the packing activity also ensure the QA clearance.
• After completing the whole operation, destroy the product by putting them into the water for waste disposal. Put all the scrap in waste bin.
• Clean the area and instrument.
• Record the result in the batch documents.
• A leak test should be performed before starting the packing activity or after each break of more than 2 hours or after any major breakdown to the packing machine or 4 hours intermittently during a continuous run of the packing machine or as instructed in the batch record.
• All the usage details shall be entered in the instrument usage log.

REFERENCE(s)

Nil.

ABBREVIATION(s)

Q.A : Quality Assurance

SOP : Standard Operating Procedure

No. : Number

P.D : Production

0C : Degree centigrade

ANNEXURE(s)

Nil.

REVISION CARD

Nil

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