Standard Operating Procedure for Maintenance of Granulators

1) Purpose

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

2) Scope

This SOP applies to all granulators used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Granulator Technician or designated personnel are responsible for the maintenance and operation of granulators.

4) Procedure

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

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 granulator maintenance, industry guidelines for granulation processes, regulatory requirements for equipment sanitation, and local safety regulations.

8) SOP Version

Version 1.0