Line Clearance in Pharmaceuticals

 Line Clearance

What is Line Clearance :

Line clearance is a process that provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or leftover of previous processing before proceeding with the next process. Quality assurance has to provide Line clearance before the start of any activity whether it is batch to batch change over and Product to product change over.

 

Criteria of Batch to batch change over :

Change over from one batch to another batch of the same product and same Strength or increasing in strength provided the excipients are the same.

Cleaning between batches of the same product but in ascending or increasing strength.

Criteria of Product to Product change over :

1. Change over from one product to another product.
2. Change over from one product to the same product with descending or decreasing strength.
3. Change over between batches/products with different colors Flavour / Excipients.
4. Change over after post maintenance or when the next product is not known (as applicable).  
5. Continuously running one batch for a longer period of time.
6. Area or Equipment is kept ideal for more period of time.

Line clearance should be carried out at change over by Manufacturing, Packaging, Raw Material Store, Packing Material Store, etc independently for the stages where final dosage form & intermediates are formed, handled and processed.

Line clearance for all area should be given as per the following points (but not limited to) :

1. On request from the concerned area for line clearance, QA will Check all the points/line & shall ensure the type of cleaning (Product to Product or Batch to Batch). If the machine/Area having Product to Product cleaning, then ensure the machine is in dismantling condition and check for the absence of previous product/material in each dismantled parts of the machine.
2. After complete verification of equipment at the dismantled condition from IPQA checklist as well as respective documents like batch records to be signed, then the production person shall go for assembling of equipment as per the plan.
3. Once the equipment line clearance is done, the equipment can be used up to its cleaning validity only, if it crosses the validity date, then re-line clearance of equipment shall be done
4. Check and ensure that the previous product/ batch materials and status labels are removed from the area.
5. Ensure that dustbins in the area are emptied out and do not carry debris of previous product/batch.
6. Check the ceiling, floor, walls, windows and door frames and electrical panels in the area are clean and free from visible traces of previous product/ batch. (Where ever applicable).
7. Ensure cleanliness of Drain point provided in the area
8. Ensure cleanliness of pendants, dust extraction hose are cleaned
9. Ensure cleanliness of Weighing balance platform and Display of balance
10. Ensure that the cleaning record for the area is updated.
11. Ensure calibration status of all pressure gauges, balances and timers are updated
12. Check that the documents pertaining to the previous product are removed from the area.
13. Check that the equipment log sheets of all machines in the area are complete as on date with cleaning details.
14. Ensure that environment conditions (Temperature & RH) record is updated.
15. Ensure that the Batch Manufacturing Record is complete in all respects up to the stage.
16. Line clearance for all equipment should be given as per checkpoints mentioned in checklists and for specific areas / Parts of the machine shall be verified accordingly the photographs available in the checklist as well as in respective Operation and cleaning SOP’s of manufacturing equipment.
17. Ensure that, the rejects of the previous product are destroyed.
18. Ensure that the area and equipment are appropriately labeled for status
19. Ensure Batch manufacturing record & Batch Packing record are completed up to the executed activity and verified.
20. Check that the machines have been cleaned as per respective SOP of the respective department for the removal of previous batch/ product.
21. The checking during line clearance should include all machine places where the product/ packaging material may get trapped. Use Additional flashlight or compressed air is required to ensure the adequacy of cleanliness at critical parts/areas. 
22.  All excess / rejected packing materials of the previous product shall be removed from the line.
23.   All used hand gloves, dusters of the previous product shall be removed from the line
24. All stereos of the previous product shall be removed/ destroyed by cutting into pieces (as applicable).
25. During line clearance of primary packing line and secondary packing line Quality Assurance personnel shall checks the complete deletion of Pharmacode / Barcode of the previous product on PLC/HMI of Machine.
26. Check the conveyor belt and area below the belt for the absence of the previous product.
27. Tools box checked for absence of previous product and Sorting tray checked for absence of the previous product.
28. Verify and ensure the correctness of the next product/ batch for label, Integrity, storage & other appropriate parameters.
29. Individual line clearance checklist shall be done and checked by production for respective equipment which shall be verified by Quality Assurance.
30. Production and Quality Assurance shall check & verify the specimen of Aluminium foil, PVC, Carton, label etc before the start of packing activity.
31. In case of dispensing of Raw & Packing material Quality assurance shall verify the release of the same from Quality Control.
32. Potency Calculation of Raw material shall be checked by production & verify by Quality Assurance.
33. Individual line clearance checklist shall be done and checked by production for respective equipment which shall be verified by Quality Assurance.