- Objective:
- To lay down a procedure for operation of labeling machine of pharmaceutical company.
- Scope:
- This SOP is applicable for sticker labeling machine.
- Responsibility:
- Production operator / Technician – responsible for operation of machine.
- Production officer / Executive – to ensure that operation of the machine is carried out as per SOP.
- Accountability:
- Production Head and QA Head shall be accountable for the compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- No.: Number
- Batch No: Batch Number
- Mfg: Manufacturing
- Exp. Date: Expiry Date
- Procedure:
- Check the status of the machine for its operation.
- Visually check the machine and surrounding area for cleanliness.
- Visually check that there is no material of the previous batch / product present.
- Write the Batch No., Product Name, Date and signature on the machine status tag.
- Take line clearance from production/in process quality assurance officers before starting the labeling operation and enter the line clearance in batch production record.
- Get the coding details of the products such as Batch No., Mfg. Date, Exp. Date & Maximum retail price from production officer.
- Take the stickers label roll from the production officer as per the secondary packing material requisition.
- Start up:
- “Switch ON” the mains electric supply to the machine.
- Set the sticker label roll on the label spool shaft provided on the labeling machine.
- Visually check missing label sensor and No label no vial sensor is properly working.
- Setting procedure:
- Auto range sensor (Orange colour): Keep sticker label in front of orange sensor then press Orange auto range sensor up to 10 seconds. Blinking of lights will start; again press auto range sensor for 02 seconds orange light will glow then output comes.
- Label sensor (Blue colour): Simultaneously press (+) and (–) button on the label, till red light blinking continuously, then press (-) button on the release paper of the roll when yellow light will glow automatically it means output given to the background of the label and also ensure that if labels not available in front of sensor then machine should stop automatically.
- Note: If background colour of the sticker label changes, the setting of label sensor is again required.
- No Label no vial sensor (Yellow colour): Before starting of the machine check No label no vial sensor is working or not if not then set the sensor according to height of the vials .During setting check the Green light should come right side of the vial neck and output goes to sensor for stop the machine when without vials label passes through conveyor.
- Set the inkjet printer according to printing position as per SOP.
- Set the coding impression by ink jet printers and get the coding details, take approval from production/ quality assurance and attach the specimen sample of label in the batch production record.
- Frequency:
- Before start of new batch or days operation.
- On completion of batch or days operation.
- Whenever a new label roll is used for labeling.
- Before and after of every joint in sticker label roll.
- Operation:
- Load vials on the in feed turn table to labeling machine.
- Switch “ON” the machine and run without vials.
- Operate the labeling machine and label 5 filled vials.
- Get the labeled vials Approved from production/ in process quality assurance officers.
- After getting the Approvals continue the labeling operation
- Set the sticker label roll with a new one after completion of the previous roll.
- Continue the operation till completion of batch.
- If sticker label roll have more then two joints in – between the roll, it should not be allowed.
- Shut down:
- After completion of the batch /days work, switch “off” the labeling machine.
- Remove the left over label roll at the end of the day’s operation. If the labeling of the batch is to be continued on the next days pack the label roll in poly bags and store under lock and key.
- Collect and count the rejected sticker label in poly bag.
- Destroy and dispose off rejected labels.
- Switch “off” the main electric supply and air supply to the machine.
- Record the operation, cleaning and maintenance details in the equipment log book as per SOP get it 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
