SOP on Line Clearance

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SOP on Line Clearance

Objective : To lay down a procedure for Line Clearance before proceeding to another product/ batch or step in the production.

Scope : This Standard Operating Procedure is applicable for formulation plant.

Responsibility :

Executive/ Officer/ Supervisor- Production / Stores to ensure line clearance as per this SOP.

Executive/ Officer- IPQA to give line clearance.

Head- QA/ designee to ensure compliance of this SOP.

Procedure

Ensure that all the cleaning of the equipment is done as per the respective SOP and cleaning details are recorded in the Machine Log sheet/ book and area is cleaned as per the respective SOP.

Before starting the new product in the Equipment or Area or Line ensure that all the equipments are cleaned and affixed with ‘CLEANED’ label.

Ensure and check visually that the previous product items e.g. labels, used polybags, use gloves, any raw / packaging materials are removed from the area.

Ensure that all Filled / Unfilled Containers, Printed / Coded Materials, Bulk Materials, Finished Goods, Scrap, Use Aids have been removed from the line. Special care must be paid for the difficult to clean areas e.g. under the packing belt, packing machine etc.

Line Clearance Checklist dispensing Area

  1. Correctness and cleaning status of Dispensing Aid Set No.
  2. Dispensing Booth cleaning status
  3. Weighing Balances cleaning and calibration status
  4. Filter cleaning status
  5. Hygrometer cleaning and calibration status
  6. Area Cleaning status
  7. Environmental conditions

Line Clearance Checklist Packing Area

  1. Check the top, below, around the belt for the remnants of previous product
  2. Check that line board is clean
  3. Check the detail of next product on line board
  4. Stereos of previous batch are destroyed
  5. Online/Batch Coding machine/inkjet printer and around area
  6. BOPP taper machine and around area
  7. There shall not be any remnants of previous batch
  8. Cleanliness of online checkweigher
  9. Packing Accessories Checked
  10. Correct Pack Material on the Line
  11.  Weighing balance
  12. Cartoner and its around area
  13. Bulk Packing Machine and its around area
  14. Cartoner  and its area
  15. Area cleaning