Standard Operating Procedure for Maintenance of Strip Packaging Machines

1) Purpose

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

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for strip packaging machines based on manufacturer recommendations and operational requirements.
   2. Inspect machine components such as forming units, sealing mechanisms, feeding systems, and cutting devices regularly for wear, alignment, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing strip 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 strip packaging machines operate within specified parameters such as strip 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 strip 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 strip 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 strip packaging machine maintenance, industry guidelines for strip packaging processes, regulatory requirements for equipment cleanliness, and local safety regulations.

8) SOP Version

Version 1.0