1.0 Objective:
To lay down a procedure for operation of carton coding machine.
2.0 Scope:
This SOP is applicable for operation of carton coding machine.
3.0 Responsibility:
Officers or above – Production.
4.0 Accountability:
Production Head.
5.0 Abbreviations
SOP : Standard Operating Procedure.
No.: Number
Date : Manufacturing Date
Date : Expiry Date
MRP : Maximum Retail Price
BPR : Batch Processing Record
6.0 Procedure:
6.1 Pre-start-up:
Check the status of the machine for its operation.
Visually check the machine and 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 vial from 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 from production officer as per the secondary packing material requisition from store.
6.2 Start up:
Note: Batch coding to be performed in a separate coding room with limited access of only acoding operator and production officer.
Ensure that one coding operation of product is carried out at one time.
Switch ”ON” the machine from main panel.
Switch on the machine and adjust the coding materials for alignment of impression.
Fix the rubber stereos on coding muster.
Put ink on ink roller and run machine till ink spread uniformly.
Get the first coded material Approved by In-process quality assurance officers and specimen sample attached in batch production record.
6.3 Operation:
Start coding operation only after getting Approval from In-process quality assurance officer.
Store the coded material in plastic crates put status tag, store the crates under lock and key in storage rack after completion of days work.
Collect and count the rejected coded materials in poly bags and do the entries in Batch Production Record.
Get the last coded material approved by In-process quality assurance officer and attached in batch production record.
Record the operation time in equipment log book as per SOP
6.4 Shut down:
After completion of the Batch, rubber stereos to be destroyed as per SOP and Enter in Batch Production Record.
After completion of the operation switch off the coding machine.
Remove the coded /encoded cartons from the machine and store 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.
7.0 Forms and Records (Annexures)
Not Applicable
8.0 Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
9.0 History
| Date | Revision Number |
Reason for Revision |
| – | 00 | New SOP |
