Standard Operating Procedure for Maintenance of Sieving Equipment

1) Purpose

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

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for sieving equipment based on manufacturer recommendations and operational requirements.
   2. Inspect equipment components such as sieve meshes, vibration motors, and seals regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing sieving 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 sieving equipment operates within specified parameters such as sieve mesh integrity, vibration efficiency, and particle size distribution.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for sieving 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 sieving 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 sieving equipment maintenance, industry guidelines for sieving processes, regulatory requirements for equipment cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0