Standard Operating Procedure for HVAC System Maintenance in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance and operation of HVAC (Heating, Ventilation, and Air Conditioning) systems within the gels production area to maintain controlled environmental conditions and ensure product quality.
2) Scope
This SOP applies to all HVAC systems and related equipment used in the pharmaceutical manufacturing facility’s gels production department.
3) Responsibilities
Facilities Management: Oversee maintenance and operation of HVAC systems.
Engineering Department: Perform routine maintenance and repairs of HVAC equipment.
Quality Assurance (QA) Team: Monitor HVAC performance and ensure compliance with regulatory requirements.
Production Supervisors: Report HVAC issues and ensure uninterrupted production activities.
4) Procedure
4.1 Routine Inspections
4.1.1 Conduct regular inspections of HVAC systems according to a predefined schedule.
4.1.2 Inspect filters, ducts, vents, and controls for cleanliness, functionality, and proper operation.
4.2 Preventive Maintenance
4.2.1 Perform preventive maintenance tasks such as cleaning, lubricating, and replacing parts as per manufacturer recommendations.
4.2.2 Schedule maintenance activities to minimize disruption to production schedules.
4.3 Calibration and Testing
4.3.1 Calibrate HVAC controls, sensors, and monitors to ensure accurate temperature and humidity control.
4.3.2 Perform testing of HVAC performance parameters (e.g., airflow, temperature differential) as part of routine checks.
4.4 Emergency Response
4.4.1 Establish procedures for responding to HVAC system failures or alarms.
4.4.2 Notify appropriate personnel and initiate corrective actions to restore HVAC functionality promptly.
4.5 Documentation and Records
4.5.1 Maintain comprehensive records of HVAC maintenance activities, including inspections, repairs, and calibration.
4.5.2 Document deviations, incidents, and corrective actions related to HVAC system performance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
HVAC: Heating, Ventilation, and Air Conditioning
QA: Quality Assurance
6) Documents, if any
– HVAC Maintenance Schedule
– HVAC Inspection and Maintenance Logs
– Calibration Certificates for HVAC Controls
7) Reference, if any
– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– Company-specific HVAC maintenance procedures and guidelines
8) SOP Version
Version 1.0