Standard Operating Procedure for Maintenance of Bottling Lines

1) Purpose

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

2) Scope

This SOP applies to all bottling lines used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Bottling Line Technician or designated personnel are responsible for the maintenance and operation of bottling lines.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for bottling lines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as fillers, cappers, conveyors, and labeling units regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing bottling lines 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 bottling lines operate within specified parameters such as fill accuracy, seal integrity, and throughput.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for bottling line malfunctions, product 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 bottling lines.

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 bottling line maintenance, industry guidelines for bottling processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0