HOT POST

50/recent/ticker-posts

Header Ads Widget

SOP for Cleaning of Double Head Aluminum Tube Filling Machine

Objective
The Objective of this SOP is to provide detailed instruction and the procedural control method for cleaning of Double head Aluminum 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 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 to perform the activity.
Checking: Production Supervisor, Technical Staff and above to counter-check the activity.

Accountability
HOD: Production/Assigned Designee for Overall Implementation in 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 adhered material of the previous batch from the hopper using a clean spatula and nozzles by operating the machine completely.
  • Clean twice 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.


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 place them in the same container.
  • By loosening check nut at piston’s end, loose 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 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 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 removed completely, 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. At the time of cleaning the machine, the main switch must be put OFF.
  3. Necessary precaution for safety concerns and others if applicable as required.
  • Acceptance CriteriaThe machine should be clean 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


Post a Comment

0 Comments

close