Standard Operating Procedure for Maintenance of Cold Storage Rooms

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of cold storage rooms in pharmaceutical manufacturing facilities to ensure proper storage conditions for temperature-sensitive materials.

2) Scope

This SOP applies to all cold storage rooms used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Cold Storage Room Technician or designated personnel are responsible for the maintenance and operation of cold storage rooms.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for cold storage rooms based on manufacturer recommendations and regulatory requirements.
   2. Inspect room components such as temperature controls, door seals, shelving, and alarms regularly for accuracy, calibration, and cleanliness.
2. Cleaning and Temperature Monitoring
   1. Follow standard operating procedures for cleaning cold storage rooms and monitoring temperature to maintain specified storage conditions.
   2. Use approved cleaning agents and temperature monitoring devices suitable for cold storage materials and requirements.
3. Performance Verification
   1. Conduct performance verification tests to ensure cold storage rooms operate within specified temperature ranges and humidity levels.
   2. Calibrate temperature monitoring equipment as per calibration procedures and maintain calibration records.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for cold storage room temperature deviations or equipment failures.
   2. Train personnel on emergency response protocols, including temperature excursion handling and containment.
5. Documentation and Reporting
   1. Maintain accurate records of equipment inspections, maintenance activities, performance tests, calibrations, temperature monitoring, and any adjustments made to the cold storage rooms.
   2. Document any incidents, temperature excursions, or deviations from standard operating procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning Procedures, Temperature Monitoring Records, Performance Verification Reports, Emergency Procedures Manual, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for cold storage room maintenance, industry guidelines for temperature-controlled storage, regulatory requirements for cold storage room cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0