Standard Operating Procedure for Maintenance of Continuous Processing Equipment

1) Purpose

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

2) Scope

This SOP applies to all continuous processing equipment used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Continuous Processing Equipment Technician or designated personnel are responsible for the maintenance and operation of continuous processing equipment.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for continuous processing equipment based on manufacturer recommendations and operational requirements.
   2. Inspect equipment components such as reactors, pumps, valves, and automation systems regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing continuous processing equipment to prevent cross-contamination and ensure product integrity.
   2. Use approved cleaning agents and methods suitable for equipment materials.
3. Performance Monitoring
   1. Monitor equipment performance during operation to identify any signs of malfunction, such as deviations in temperature, pressure, or flow rates.
   2. Adjust equipment settings or perform minor repairs as necessary to maintain optimal performance.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for continuous processing equipment malfunctions, process deviations, 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 monitoring, and any repairs or adjustments made to the continuous processing equipment.
   2. Document any incidents or near misses related to continuous processing equipment operation.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Sanitization Procedures, Performance Monitoring Records, Emergency Procedures Manual, Incident Reports

7) Reference, if any

Manufacturer’s recommendations for continuous processing equipment maintenance, industry guidelines for continuous production processes, regulatory requirements for equipment cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0