Standard Operating Procedure for Maintenance of Sterilization Equipment

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of sterilization equipment to ensure proper sterilization and operational reliability in the pharmaceutical manufacturing process.

2) Scope

This SOP applies to all sterilization equipment used in pharmaceutical manufacturing and laboratory settings, including but not limited to steam sterilizers and dry heat sterilizers.

3) Responsibilities

The Sterile Operations Department or Laboratory Management 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, sterilization 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 sterilization equipment according to the schedule.
   2. Check pressure, temperature, and cycle settings.
   3. Clean chambers and inspect gaskets for wear or damage.
   4. Verify proper functioning of steam generation, heating elements, and ventilation systems.
3. Corrective Maintenance Procedures
   1. Address any deviations from specified sterilization parameters promptly.
   2. Diagnose the root cause of the issue and determine necessary repairs.
   3. Perform repairs using approved spare parts and procedures.
   4. Conduct validation runs to ensure proper sterilization efficacy post-repair.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document sterilization 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, Sterilization Logs, Maintenance Records, Equipment Manuals

7) Reference, if any

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

8) SOP Version

Version 1.0