Standard Operating Procedure for Maintenance of Capsule Filling Machines

1) Purpose

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

2) Scope

This SOP applies to all capsule filling machines used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Capsule Filling Machine Technician or designated personnel are responsible for the maintenance and operation of capsule filling machines.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for capsule filling machines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as dosing disc, powder hopper, capsule magazine, and compression station regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing capsule filling machines 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 capsule filling machines operate within specified parameters such as fill weight, capsule integrity, and reject rate.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for capsule filling machine malfunctions, powder 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 capsule filling machines.

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 capsule filling machine maintenance, industry guidelines for capsule filling processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0