Standard Operating Procedure for Maintenance of Refrigeration Units

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of refrigeration units to ensure optimal performance and reliability in storing pharmaceutical products.

2) Scope

This SOP applies to all refrigeration units used in pharmaceutical storage facilities, including cold rooms and freezers.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Maintenance Team is responsible for executing maintenance activities.

4) Procedure

1. Maintenance Schedule Planning
   1. Develop a maintenance schedule based on equipment criticality, temperature requirements, manufacturer recommendations, and operational history.
   2. Assign specific maintenance tasks to qualified personnel.
   3. Document the schedule and ensure it is communicated to relevant departments.
2. Preventive Maintenance Tasks
   1. Perform routine inspections of refrigeration units according to the schedule.
   2. Check temperature settings and verify proper operation of cooling systems.
   3. Clean condenser coils, fans, and evaporator units to ensure efficient heat exchange.
   4. Inspect and replace refrigerant as needed, following environmental regulations.
3. Corrective Maintenance Procedures
   1. Address temperature deviations or equipment malfunctions promptly.
   2. Diagnose the root cause of the issue and determine necessary repairs.
   3. Perform repairs using approved spare parts and procedures.
   4. Verify temperature stability and functionality post-repair.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document temperature logs, maintenance logs, and any deviations from standard operating conditions.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Schedules, Temperature Logs, Maintenance Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance of refrigeration units.

8) SOP Version

Version 1.0