Standard Operating Procedure for Maintenance of Labeling Machines

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of labeling machines in pharmaceutical manufacturing facilities to ensure accurate labeling processes and product quality.

2) Scope

This SOP applies to all labeling machines used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Labeling Machine Technician or designated personnel are responsible for the maintenance and operation of labeling machines.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for labeling machines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as label applicators, sensors, rollers, and conveyor systems regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing labeling machines to prevent cross-contamination and ensure label adhesion.
   2. Use approved cleaning agents and methods suitable for equipment materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure labeling machines operate within specified parameters such as label placement accuracy and speed.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for labeling machine malfunctions, label jams, or other incidents.
   2. Train personnel on emergency shutdown procedures and containment protocols.
5. Documentation and Reporting
   1. Maintain accurate records of equipment inspections, maintenance activities, performance tests, and calibration results.
   2. Document any incidents, repairs, or adjustments made to the labeling machines.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Sanitization Procedures, Performance Verification Reports, Emergency Procedures Manual, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for labeling machine maintenance, industry guidelines for labeling processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0