SOP FOR OPERATION AND CLEANING OF STICKER LABELLING MACHINE
OBJECTIVE: To lay down the procedure for operation and cleaning of Sticker Labelling machine.
SCOPE: This procedure is applicable for operation and cleaning of Sticker Labelling machine.
RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP.
Officer/Supervisor or designee of IPQA is responsible for the line clearance and verification of the related documents along with ensuring the compliance of SOP.
Technician/Officer or designee of engineering department is responsible for the maintenance/repair work of the machine if any break down occurs during the operation.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records.
QA responsible for verification of completion of product to the procedure.
ACCOUNTABILITY: Head of the Production Department.
PROCEDURE:
Pre-start up:
Check the status of the machine for its operation.
Ensure that no remnants of previous product/batch are present.
Visually check the equipment and area for its cleanliness.
Ensure “cleaned” label status on the equipment.
Check the cleanliness of the room.
Check the material kept in the room and ensures that it is of the same batch to proceed.
Write the Batch no., Product name, Date and signature on the machine status tag.
Get the coding details of the product such as: Batch no. Mfg. date, Exp date and Maximum retail price from production officer.
Check the room temperature and record it. If it is not within the limit inform the maintenance department and do not proceed till it gets rectified.
Start up:
Replace “cleaned” label with “Under process” label.
Take line clearance from IPQA and record in BPR.
Switch “ON” the main electric supply of the machine.
Check the machine for any abnormal noise by pushing the start switch button.
Set the label roll on the label spool shaft provided on the Labelling machine.
Visually check missing label sensor and No label no bottle sensor properly working.
Setting Procedure:
Auto range sensor (Orange colour): Keep sticker label in front of orange sensor then press Orange auto sensor up to 10 seconds. Blinking of light 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 on the roll when yellow light will glow automatically it means output given to the background on 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 the label sensor is again required.
No Bottle no Labelling sensor (Yellow sensor): Before starting of the machine Check No label no ampoule/bottle 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/bottle neck and output goes to sensor for stop the machine when without ampoules/bottle label passes through the conveyor.
Set the ink Type Cartridge printer according to printer position as per SOP.
Set the coding impression by ink Type Cartridge printer and get the coding details, take approval from production / Quality Assurance and attach the specimen sample of the label in the Batch production record.
Frequency:
Before start of new Batch or days operation.
On completion of new 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 bottle on the in feed turn table to Labelling machine.
Switch on the machine and run without bottle.
Operate the Labelling machine and label 5 filled bottles.
Get the labelled bottles approved from production / in process quality assurance officers.
After getting the approvals continue the Labelling operation.
Set the sticker label roll with a new one after completion of the previous roll.
Continue the operation till completion of the batch.
If sticker label roll have more than two joints in-between the roll, it should not be allowed.
Shut Down:
After completion of the Batch / days’ work, switch “off” the Labelling machine.
Remove the left over label roll at the end of the day’s operation. If the Labelling of the Batch is to be continued on the next day pack the label roll in poly bags and store under lock and key.
Collect and count the rejected stickers label in poly bags.
Destroy and Dispose of 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.