Objective
To lay down a procedure for the operation of the carton coding machine.
Scope
This SOP is applicable to the operation of the carton coding machine.
Responsibility
Officers or above – Production.
Accountability
Production Head.
Procedure
Pre-start-up:
- Check the status of the machine for its operation.
 - Visually check the machine and the surrounding area for cleanliness.
 - Visually ensure that there are no remnants of the previous Batch/day operation.
 - Take the line clearance from In-process quality assurance officer before starting the coding operation and enter the line in Batch Production Record.
 - Write the Batch No. Product Name, Date, and Signature on the machine status tag.
 - Get the coding details such as Batch No., Mfg. Date, Exp. Date & MRP of the vial from the production officer.
 - Get the rubber stereos from the production officers and enter in the batch production record and set the rubber stereos on the stereo master.
 - Take the unit cartons already issued by the production officer as per the secondary packing material requisition from the store.
 
Start up:
Note: Batch coding will be performed in a separate coding room, with limited access to only a coding operator and a production officer.
- Ensure that one coding operation of the product is carried out at a time.
 - Switch ”ON” the machine from the main panel.
 - Switch on the machine and adjust the coding materials for alignment of the impression.
 - Fix the rubber stereos on the coding muster.
 - Put ink on the ink roller and run the machine till the ink spreads uniformly.
 - Get the first coded material approved by the In-process quality assurance officers, and the specimen sample attached in the batch production record.
 
Operation:
- Start coding operation only after getting Approval from In-process quality assurance officer.
 - Store the coded material in plastic crates put a status tag, store the crates under lock and key in a storage rack after completion of days work.
 - Collect and count the rejected coded materials in poly bags and do the entries in the Batch Production Record.
 - Get the last coded material approved by In-process quality assurance officer and attach in the batch production record.
 - Record the operation time in the equipment logbook as per SOP.
 
Shut down:
- After completion of the Batch, rubber stereos to be destroyed as per SOP and Enter in the Batch Production Record.
 - After completion of the operation, switch off the coding machine.
 - Remove the coded /encoded cartons from the machine and store them under lock and key.
 - Collect and count the rejected unit cartons from the machine and kept in polybags  and enter the quantity in BPR.
 - Destroy and dispose off the collected unit cartons.
 - Switch off the main electric supply. Record the operation, cleaning & Maintenance details in the equipment log book as per SOP and get checked by production officer.
 
Annexures
Nil
Abbreviations
SOP: Standard Operating Procedure.
No.: Number
MRP: Maximum Retail Price
BPR: Batch Processing Record
Distribution
Master copy –   Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
Revision History
Nil
 
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