SOP for Cleaning of Double Head Aluminum Tube Filling Machine

Objective

The Objective of this SOP is to provide detailed instructions and the procedural control method for cleaning of Double head Aluminium tube filling machine in the Production Department.

Scope

The scope of this SOP is to lay down the detailed procedure for a Double head aluminum tube filling machine that has to be cleaned after the completion of every product and at the end of the working shift, to control cross-contamination. This SOP provides the detailed procedure, requirements, and precautions to be considered while cleaning the machine.

Responsibility

Performance: Worker, Operator, and Technician Responsible for performing the activity.

Checking: Production Supervisor, Technical Staff, and above to counter-check the activity.

Accountability

HOD: Production/Assigned Designee for Overall Implementation in the System with effective Procedural control to compliance.

HOD QA/Designee: Responsible for review, approval of the Master document, and compliance with the procedure in a production department.

Procedure

Change over of Batch:

• Remove the “To Be Cleaned” label.
• Remove empty and salvaged tubes of the previous batch.
• Remove the adhered material of the previous batch from the hopper using a clean spatula and nozzles by operating the machine completely.
• Clean twice the hopper, nozzles, surrounding, and the outer surface of the machine with a wet clean lint-free cloth, and then wipe with dry with a clean lint-free cloth.
• Change the batch coding letters of the previous batch and set them for the next batch.
• Now the machine is ready for the next batch.
• Affix the “CLEANED” label.

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Change over of the Product:

• Remove the “To Be Cleaned” label.
• Remove empty and salvaged tubes of the previous batch/product.
• Remove the hopper and lid from the machine and take it to the washing room for cleaning.
• Remove filling nozzles and air nozzles from the machine and place them in a suitable container to take for cleaning.
• Lose both the bolts in the S.S. cover of the block and pull out the piston valve from the block and place it in the same container.
• After removal of the knob of the piston valve, open four nuts and then remove the filling block and place it in the same container.
• Take out both syringes and pistons by opening the piston end attached to the guide track and placing them in the same container.
• By loosening the check nut at the piston’s end, lose the Teflon washer. Take out pistons from the syringes and place them in the same container.
• Unscrew rings, dies, and cups from the turntable and place them in the above container.
• Take all the above parts collected in the above container to the washing area.
• Remove the batch coding letters of the previous product and preserve them properly.
• Clean the hopper, lid and all dismantled parts of the machine with raw water so that adhered material is completely removed from all parts. Clean all the parts with a sufficient quantity of tepol Solution 10% using a scrubber.

• Clean with a sufficient quantity of raw water so that the traces of soap solution are obliterated, and check the rinse physically for the absence of traces of ExtranSolution.
• If required repeat step No 13 to get a complete clear rinse.
• Finally, rinse all the parts with sufficient purified water to get a clear final rinse.
• Intimate QA Officer to check the sample of rinse water for clearance.
• Clean twice the outer surface of the machine with wet clean lint-free cloth and wipe dry with a clean lint-free cloth.
• Assemble all parts of the machine in its position and keep the machine ready, cover the filling nozzles with PE sleeve
• Affix the “CLEANED” label.

Precaution:  

1. Do not clean the parts with bearings of filling assembly with water.
2. When cleaning the machine, the main switch must be turned off.
3. Necessary precaution for safety concerns and others if applicable as required.

Acceptance Criteria: The machine should be cleaned thoroughly and made free from traces of previous product

Frequency: After completion of batch and before use, as and when required.

Annexure

Annexure-1: Equipment Cleaning Log Book

Abbreviations

SOP: Standard Operating Procedure

HOD: Head of the Department

Revision History

Nil

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