Standard Operating Procedure for Maintenance of Water Purification Systems

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of water purification systems to ensure the production of high-quality purified water for pharmaceutical manufacturing processes.

2) Scope

This SOP applies to all water purification systems used in pharmaceutical manufacturing and laboratory settings, including but not limited to reverse osmosis (RO) systems and distillation units.

3) Responsibilities

The Quality Control 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, water quality 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 water purification systems according to the schedule.
   2. Check inlet and outlet pressures, monitor flow rates, and inspect filtration membranes.
   3. Clean filters, replace cartridges, and sanitize system components as needed.
   4. Verify proper functioning of pumps, valves, and monitoring sensors.
3. Corrective Maintenance Procedures
   1. Address any deviations from water quality specifications 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 tests to ensure water quality compliance post-repair.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document water quality monitoring 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, Water Quality Monitoring Logs, Maintenance Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance of water purification systems.

8) SOP Version

Version 1.0