Standard Operating Procedure for Maintenance of Autoclaves

1) Purpose

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

2) Scope

This SOP applies to all autoclaves used in pharmaceutical manufacturing and laboratory settings.

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 autoclaves according to the schedule.
   2. Check pressure, temperature, and cycle settings.
   3. Verify proper functioning of steam generation, heating, and ventilation systems.
   4. Clean chamber and inspect gaskets for wear or damage.
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 autoclaves.

8) SOP Version

Version 1.0