Standard Operating Procedure for Maintaining Temperature and Humidity Control Systems in Nebulizer Manufacturing Areas
1) Purpose
The purpose of this SOP is to provide a standardized procedure for the maintenance of temperature and humidity control systems to ensure consistent environmental conditions in nebulizer production areas, thereby maintaining product quality and compliance with regulatory standards.
2) Scope
This SOP applies to all temperature and humidity control systems, including HVAC systems, dehumidifiers, and monitoring devices, in the nebulizer manufacturing facility.
3) Responsibilities
Operators: Perform routine monitoring and report any deviations.
Maintenance Team: Conduct regular maintenance, troubleshooting, and calibration of control systems.
Quality Assurance (QA): Validate environmental conditions and review maintenance records.
4) Procedure
4.1 Routine Monitoring
- Inspect the temperature and humidity control systems daily to ensure they are operational.
- Record temperature and humidity levels at designated intervals in the Environmental Monitoring Log.
- Report any deviations or alarms to the maintenance team immediately.
4.2 Preventive Maintenance
- Weekly Maintenance:
- Clean air filters in HVAC units to ensure proper airflow.
- Inspect ducts and vents for blockages or damage.
- Check the calibration of temperature and humidity sensors using a reference device.
- Monthly Maintenance:
- Lubricate moving parts, such as fans and blowers, in HVAC systems.
- Inspect and replace dehumidifier desiccants or filters as needed.
- Perform a system diagnostic test using the control system’s software interface.
4.3 Calibration of Monitoring Devices
- Use certified calibration equipment to verify the accuracy of temperature and humidity sensors.
- Document pre- and post-calibration readings in the Calibration Log.
- Replace any sensors that fail calibration or show significant deviations.
4.4 Emergency Maintenance
- If the system malfunctions, shut it down using the emergency stop mechanism.
- Identify the cause of the failure and isolate the affected area to prevent contamination.
- Repair or replace faulty components, such as compressors, thermostats, or humidifiers, as needed.
- Resume operations only after the system has been validated by the QA team.
4.5 Post-Maintenance Activities
- Perform a final inspection of the system to ensure proper functionality.
- Document all maintenance activities, including repairs, replacements, and calibrations, in the Maintenance Log.
- Submit the maintenance records to the QA team for review and approval.
5) Abbreviations
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
6) Documents
The following documents should be maintained:
- Environmental Monitoring Log
- Temperature and Humidity Calibration Log
- Maintenance Log for Control Systems
7) References
Relevant regulatory guidelines and references include:
- ISO 14644: Cleanrooms and Associated Controlled Environments
- Good Manufacturing Practices (GMP) Guidelines
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Environmental Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Recorded By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Measured Temp | Measured Humidity | Operator Name | Details |
Annexure Title: Temperature and Humidity Calibration Log
| Date | Sensor ID | Pre-Calibration Reading | Post-Calibration Reading | Performed By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Sensor Identifier | Pre-Reading | Post-Reading | Technician Name | Details of Calibration |
Annexure Title: Maintenance Log for Control Systems
| Date | System ID | Maintenance Type | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | System Identifier | Routine/Emergency | Technician Name | QA Name | Details of Maintenance |