HVAC System Maintenance Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for the maintenance of Heating, Ventilation, and Air Conditioning (HVAC) systems in metered-dose inhaler (MDI) production areas to ensure optimal air quality, environmental conditions, and compliance with regulatory requirements.

2) Scope

This SOP applies to all HVAC systems and associated equipment within the MDI production facility, including air handling units, filters, ductwork, and temperature control systems.

3) Responsibilities

The responsibilities for this SOP include performing routine maintenance, monitoring system performance, and ensuring proper functioning of HVAC systems to support production activities and maintain cleanroom standards.

4) Procedure
4.1 Routine Maintenance

4.1.1 Develop a schedule for routine HVAC maintenance based on manufacturer recommendations, regulatory requirements, and facility needs.

4.1.2 Perform regular inspections, cleaning, and replacement of HVAC filters according to schedule.

4.2 Temperature and Humidity Control

4.2.1 Monitor and record temperature and humidity levels in production areas using calibrated instruments.

4.2.2 Adjust HVAC settings as needed to maintain specified environmental conditions for MDI production.

4.3 Air Quality Monitoring

4.3.1 Conduct air quality tests periodically to ensure compliance with cleanliness and particulate standards.

4.3.2 Address any deviations from air quality standards promptly, including investigation and corrective actions.

4.4 Emergency Procedures

4.4.1 Develop and maintain emergency response procedures for HVAC system failures or environmental control issues.

4.4.2 Ensure availability of backup systems or contingency plans for critical HVAC components.

4.5 Documentation and Reporting

4.5.1 Document all HVAC maintenance activities, including inspections, tests, repairs, and calibration records.

4.5.2 Prepare maintenance reports and logbooks to track system performance and compliance with regulatory requirements.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler

SOP: Standard Operating Procedure

HVAC: Heating, Ventilation, and Air Conditioning

6) Documents, if any

HVAC maintenance schedules, inspection records, calibration certificates, air quality test reports, and emergency response plans should be maintained.

7) Reference, if any

Refer to HVAC system maintenance guidelines from regulatory agencies, industry standards, and equipment manufacturers.

8) SOP Version

Version 1.0