Standard Operating Procedure for Maintenance of Tablet Presses

1) Purpose

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

2) Scope

This SOP applies to all tablet presses used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Tablet Press Technician or designated personnel are responsible for the maintenance and operation of tablet presses.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for tablet presses based on manufacturer recommendations and operational requirements.
   2. Inspect tablet press components such as tooling, cams, feeder, and compression rollers regularly for wear, alignment, or contamination.
2. Cleaning and Lubrication
   1. Follow standard operating procedures for cleaning and lubricating tablet press components to prevent cross-contamination and ensure smooth operation.
   2. Use approved cleaning agents and lubricants suitable for equipment materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure tablet presses operate within specified parameters such as tablet weight, hardness, and dissolution.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for tablet press malfunctions, tooling jams, 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 tablet presses.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Lubrication Procedures, Performance Verification Reports, Emergency Procedures Manual, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for tablet press maintenance, industry guidelines for tablet manufacturing, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0