Standard Operating Procedure for Maintenance of Dehumidifiers

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of dehumidifiers to ensure optimal humidity control in pharmaceutical manufacturing and storage areas.

2) Scope

This SOP applies to all dehumidifiers used in pharmaceutical manufacturing facilities, laboratories, and storage areas.

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, humidity control 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 dehumidifiers according to the schedule.
   2. Check and clean air filters and coils to maintain efficiency.
   3. Inspect drainage systems and ensure proper water removal.
   4. Calibrate humidity sensors and controls as per specifications.
3. Corrective Maintenance Procedures
   1. Address any deviations from humidity control parameters promptly.
   2. Diagnose the root cause of issues and determine necessary repairs.
   3. Replace malfunctioning components using approved spare parts and procedures.
   4. Conduct operational tests post-repair to ensure proper humidity control.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document humidity control 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, Humidity Control Logs, Maintenance Records, Equipment Manuals

7) Reference, if any

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

8) SOP Version

Version 1.0