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SOP for operation of carton coding machine

  • 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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