- Objective:To lay down a procedure for operation of carton coding machine.
- Scope:
- This SOP is applicable for operation of carton coding machine.
- Responsibility:
- Officers or above – Production.
- Accountability:
- Production Head.
- Abbreviations
- SOP : Standard Operating Procedure.
- No.: Number
- Date : Manufacturing Date
- Date : Expiry Date
- MRP : Maximum Retail Price
- BPR : Batch Processing Record
- Procedure:
- 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.
- 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.
- 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
- 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.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
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