Standard Operating Procedure for Using Labeling Machine

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the labeling machine used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate labeling of product containers.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the labeling machine in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the labeling machine as per this SOP.
Quality Control (QC) Personnel: Responsible for inspecting labels for quality and accuracy.
Maintenance Personnel: Responsible for maintaining the labeling machine in proper working condition.

4) Procedure

4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the labeling machine is installed on a stable, level surface in the packaging area.
4.1.1.2 Verify that the label roll and ink supplies are sufficient for the intended production run.
4.1.1.3 Check that the machine is set up for the correct label size and product container configuration.

4.1.2 Setup
4.1.2.1 Load the label roll into the machine and thread the labels through the labeling head.
4.1.2.2 Adjust the machine settings such as label position, speed, and alignment according to product specifications.
4.1.2.3 Perform a trial run to ensure labels are applied accurately and securely.

4.1.3 Labeling Process
4.1.3.1 Feed product containers into the labeling machine at the specified rate.
4.1.3.2 Ensure that each container is aligned correctly with the labeling head for accurate label application.
4.1.3.3 Activate the labeling mechanism to apply labels securely to each container.

4.1.4 Inspection and Verification
4.1.4.1 Inspect labeled containers for quality, including label position, alignment, and adhesive integrity.
4.1.4.2 Perform periodic checks to verify that labels meet regulatory requirements for product information.
4.1.4.3 Reconcile labels used against production records to ensure accuracy and traceability.

4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the labeling machine’s label placement, alignment, and adhesive application.
4.2.1.2 Verify the accuracy of label printing and barcoding if applicable.
4.2.1.3 Record the results in the equipment log.

4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the labeling machine monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.

4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the labeling machine components daily to remove adhesive buildup and debris.
4.3.1.2 Inspect and replace worn parts such as labeling heads and rollers to maintain label application quality.
4.3.1.3 Lubricate moving parts according to manufacturer recommendations.

4.3.2 Troubleshooting
4.3.2.1 If labels fail to adhere properly or if label placement is incorrect, refer to the manufacturer’s manual for troubleshooting.
4.3.2.2 Contact maintenance personnel for repairs if issues cannot be resolved.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Labeling log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the labeling machine
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0