Standard Operating Procedure for HVAC System Maintenance in Aerosol Production

1) Purpose

The purpose of this SOP is to outline the procedures for maintaining the Heating, Ventilation, and Air Conditioning (HVAC) systems in aerosol production areas. Proper maintenance ensures that the HVAC systems operate efficiently, providing controlled environmental conditions that meet regulatory requirements and ensure product quality.

2) Scope

This SOP applies to all HVAC systems serving aerosol production areas at [Company Name], including cleanrooms, production rooms, and storage areas.

3) Responsibilities

Facilities Manager: Oversee HVAC system maintenance and ensure compliance with procedures.
Maintenance Technicians: Perform routine maintenance and inspections of HVAC systems.
Quality Assurance (QA) Manager: Ensure that HVAC maintenance activities comply with regulatory requirements.
All Personnel: Report any HVAC system issues or deviations from normal operation.

4) Procedure

4.1 Routine HVAC Maintenance:
4.1.1 Develop a schedule for routine maintenance tasks, including filter changes, belt replacements, and lubrication.
4.1.2 Perform inspections of HVAC components such as fans, coils, and ductwork for signs of wear or damage.
4.1.3 Keep records of maintenance activities, including dates, tasks performed, and any issues identified.

4.2 Calibration of HVAC Controls:
4.2.1 Calibrate HVAC controls, sensors, and instruments to ensure accurate temperature and humidity control.
4.2.2 Conduct periodic testing of HVAC alarms and safety features to verify proper operation.
4.2.3 Document calibration activities and maintain calibration records as per SOP.

4.3 Cleaning and Sanitization:
4.3.1 Clean HVAC components and ductwork regularly to prevent buildup of contaminants and microbial growth.
4.3.2 Use approved cleaning agents and methods that do not leave residues harmful to product quality.
4.3.3 Perform sanitization of HVAC systems according to schedule and documented procedures.

4.4 Emergency Maintenance Response:
4.4.1 Establish procedures for responding to HVAC system failures or alarms.
4.4.2 Notify appropriate personnel immediately of any critical HVAC system issues.
4.4.3 Implement contingency measures to maintain environmental control during HVAC downtime.

4.5 Validation and Qualification:
4.5.1 Conduct validation and qualification activities for HVAC systems, including performance testing and airflow studies.
4.5.2 Ensure that HVAC systems meet specified performance criteria and regulatory requirements.
4.5.3 Document validation and qualification results and maintain records for regulatory inspections.

4.6 Preventive Maintenance Planning:
4.6.1 Develop and update a preventive maintenance plan based on equipment manufacturer recommendations and regulatory guidelines.
4.6.2 Review and revise the maintenance plan as needed based on system performance data and feedback from maintenance personnel.
4.6.3 Schedule preventive maintenance activities to minimize disruption to production operations.

5) Abbreviations, if any

HVAC: Heating, Ventilation, and Air Conditioning
QA: Quality Assurance
SOP: Standard Operating Procedure

6) Documents, if any

HVAC Maintenance Schedule
Calibration Records
Cleaning and Sanitization Logs
Validation and Qualification Reports

7) Reference, if any

GMP Guidelines
ISO 14644: Cleanrooms and Associated Controlled Environments
ASHRAE Standards for HVAC Systems

8) SOP Version

Version 1.0