Standard Operating Procedure for Maintenance of Cartoning Machines

1) Purpose

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

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for cartoning machines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as carton feeders, pushers, conveyors, and folding mechanisms regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing cartoning machines to prevent cross-contamination and ensure product integrity.
   2. Use approved cleaning agents and methods suitable for equipment materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure cartoning machines operate within specified parameters such as carton fill accuracy, closure integrity, and throughput.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for cartoning machine malfunctions, product 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 cartoning 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 cartoning machine maintenance, industry guidelines for cartoning processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0