Standard Operating Procedure for Maintenance of Coating Machines

1) Purpose

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

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for coating machines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as spray guns, atomizers, coating drums, and air handling systems regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing coating machines to prevent cross-contamination and ensure product purity.
   2. Use approved cleaning agents and methods suitable for equipment materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure coating machines operate within specified parameters such as coating thickness, uniformity, and drying time.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for coating machine malfunctions, spills, 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 coating 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 coating machine maintenance, industry guidelines for coating processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0