Standard Operating Procedure for Maintenance of Blister Packaging Machines

1) Purpose

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

2) Scope

This SOP applies to all blister packaging machines used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Blister Packaging Machine Technician or designated personnel are responsible for the maintenance and operation of blister packaging machines.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for blister packaging machines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as forming dies, sealing stations, feed systems, and conveyor belts regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing blister packaging machines 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 blister packaging machines operate within specified parameters such as blister 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 blister packaging machine malfunctions, product 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 blister packaging 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 blister packaging machine maintenance, industry guidelines for blister packaging processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0