Standard Operating Procedure for HVAC System in Pharmaceutical Manufacturing
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the HVAC (Heating, Ventilation, and Air Conditioning) system in the pharmaceutical manufacturing of otic dosage forms to ensure controlled environmental conditions.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the HVAC system in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the HVAC system as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying environmental conditions.
Maintenance Personnel: Responsible for maintaining the HVAC system in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the HVAC system for cleanliness and integrity before use.
4.1.1.2 Ensure that all filters, ducts, and connections are intact and functional.
4.1.1.3 Verify that the HVAC control system is operational.
4.1.2 Preparation
4.1.2.1 Ensure that the HVAC system is set to the required temperature, humidity, and airflow settings.
4.1.2.2 Check that all sensors and monitoring equipment are calibrated and functional.
4.1.2.3 Perform a system start-up check as per manufacturer’s instructions.
4.2 Operation
4.2.1 Monitoring Environmental Conditions
4.2.1.1 Power on the HVAC system and initiate the airflow.
4.2.1.2 Continuously monitor the temperature, humidity, and airflow to ensure they remain within specified limits.
4.2.1.3 Record environmental conditions at regular intervals as per the monitoring protocol.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE when inspecting or maintaining the HVAC system.
4.2.2.2 Handle all HVAC components with care to prevent damage or contamination.
4.2.2.3 Follow all safety protocols for working with electrical and mechanical systems.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Power off the HVAC system after completing the operation.
4.3.1.2 Clean the air filters and ducts if necessary.
4.3.1.3 Secure the system for the next use.
4.3.2 Maintenance
4.3.2.1 Regularly inspect the HVAC system for wear and tear, and perform necessary repairs.
4.3.2.2 Replace air filters and other consumable components as per the manufacturer’s recommendations.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.
5) Abbreviations, if any
HVAC: Heating, Ventilation, and Air Conditioning
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Environmental monitoring records
Maintenance records for the HVAC system
7) Reference, if any
Manufacturer’s manual for the HVAC system
Pharmacopeial guidelines for environmental control in pharmaceutical manufacturing
8) SOP Version
Version 1.0