SOP for Operation and Cleaning of Sticker Labelling Machine

OBJECTIVE

To provide a procedure for properly using and cleaning the sticker labeling machine.

SCOPE

This procedure applies to the operation and cleaning of sticker labeling machines.

RESPONSIBILITY

Operator: To operate machine and clean bottles as per procedure.

Supervisor: To ensure procedure is being followed.

QA personnel: To verify and certify that the machine is ready for use.

PROCEDURE

Procedure for Start up

• 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.
• Write the Batch no, Product name, Date and Signature on the machine status tag.
• Take the line clearance from production/QA officers before starting the labeling operation and enter the line clearance in batch production record.
• Get the coding detail of the products such as Batch no, mfg. date, Exp. Date from the batch record.

• Take the sticker label roll from packing supervisor as per the secondary packing material requisition.
• Now switch “ON” the main electrical 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 id properly working.

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Procedure for setting

Label roll fitting & guide setting:

• Remove top acrylic disc
• Adjust the label roll properly in the base acrylic disc.
• Adjust the alignment guides of the roller with proper fitting.
• Fix the label roll
• Align the guide as per product.

Label gap sensor setting:

• Align the label sensor that the label roll Should pass straightly from the label gap sensor.
• Adjust the label sensitivity with the label pot which is on the sensor
• Adjust label gap licks as

1. Label passes through Red L.E.D. off.
2. The gap between the two labels Red L.E.D. on

Product sensor setting:

• Adjust the product sensor from the products to 10mm to 50mm.
• Set the product sensor – red L.E.D. – off

1. Product under sensor – Red L.E.D. on
2. The product passed under the sensor – Red L.E.D. off.

• Set the sensitivity properly with the help of the pot on the top of the product sensor.
• Set the coding impression by inkjet printers get the coding details, and get approval from the packing supervisor/Q.A and attach the specimen sample of the label in the batch packing record.

Frequency

• Before the start of the new batch or days of operation.
• On completion of batch or days operation.
• Whenever a new label roll is used for labeling
• Before and after every joint in sticker label roll.

Procedure for operation

• Load vials on the in-feed turn table to the labeling machine.
• Switch “ON” the machine and run without vials.
• Operate the labeling machine and label 5 filled vials.
• Get the labeled vials approved by production/QA officers.
• After getting the approvals continue the labeling operation.
• Set the sticker label roll with a new one after the completion of the previous roll.
• Continue the operation till the completion of the batch.
• If a sticker label roll has more than two joints in between the roll, it should not be allowed.

Procedure for cleaning

• After completing the batch/ day’s work, switch “OFF” the labeling machine.
• Remove the leftover label roll at the end of the day’s operation. If the labeling of the batch is to be continued on the next day pack the label roll in poly bags and store it under lock and key.
• Collect and count the rejected sticker labels in poly bags.
• Destroy and dispose of rejected labels.
• Switch “OFF” the machine's main electrical and air supply.
• Record the operation, cleaning, and maintenance details in the equipment log book as per SOP and get it checked by the production supervisor.

ABBREVIATIONS

QA: Quality Assurance.

QC: Quality Control

SOP: Standard Operating Procedure

No.: Number

Batch No.: Batch Number

Mfg. Date: Manufacturing Date

Exp. Date Expiry Date

L.E.D.: Light Emitting Diode

ANNEXURE

Nil

REVISION HISTORY

Nil

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