Standard Operating Procedure for HVAC System Maintenance
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance of HVAC (Heating, Ventilation, and Air Conditioning) systems in manufacturing areas involved in the production of dental dosage forms to ensure proper functioning and compliance with environmental control requirements.
2) Scope
This SOP applies to all HVAC systems serving areas where dental pastes, gels, and mouthwashes are produced within the pharmaceutical industry.
3) Responsibilities
The Facilities Management Department is responsible for conducting HVAC system maintenance. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Routine Maintenance
4.1.1 Develop a schedule for routine maintenance activities based on manufacturer’s recommendations and regulatory requirements.
4.1.2 Perform visual inspections of HVAC components for signs of wear, damage, or deterioration.
4.1.3 Clean or replace air filters as per schedule and condition.
4.2 Calibration and Testing
4.2.1 Calibrate temperature and humidity sensors regularly as per calibration schedule.
4.2.2 Conduct airflow measurements and adjust dampers and vents as needed to maintain proper air distribution.
4.3 Cleaning and Disinfection
4.3.1 Clean HVAC ducts, coils, and condensate pans periodically to prevent microbial growth and contamination.
4.3.2 Use approved cleaning agents and disinfectants for cleaning HVAC components.
4.4 Emergency Maintenance
4.4.1 Respond promptly to HVAC system failures
4.4.2 Document emergency maintenance activities and any corrective actions taken.
4.5 Record Keeping
4.5.1 Maintain records of all HVAC maintenance activities, including inspections, repairs, and preventive maintenance.
4.5.2 Document any deviations from maintenance procedures and corrective actions taken.
4.6 Verification and Validation
4.6.1 Verify HVAC system performance through periodic testing and validation activities.
4.6.2 Validate HVAC system parameters such as temperature, humidity, and airflow to ensure compliance with specified requirements.
5) Abbreviations, if any
HVAC – Heating, Ventilation, and Air Conditioning
QA – Quality Assurance
6) Documents, if any
HVAC Maintenance Log
Validation Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
