Standard Operating Procedure for Maintenance of Milling Equipment

1) Purpose

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

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for milling equipment based on manufacturer recommendations and operational requirements.
   2. Inspect equipment components such as blades, screens, motors, and controls regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing milling equipment 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 milling equipment operates within specified parameters such as particle size distribution, throughput, and power consumption.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for milling equipment malfunctions, blockages, 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 milling equipment.

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 milling equipment maintenance, industry guidelines for milling processes, regulatory requirements for equipment cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0