Standard Operating Procedure for HVAC System in Clean Room

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the HVAC (Heating, Ventilation, and Air Conditioning) System in the clean room environment used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the HVAC System serving the clean rooms used in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, monitoring, and maintenance of the HVAC System. Facility engineers are responsible for following this procedure, and the maintenance team is responsible for regular maintenance and calibration.

4) Procedure

4.1 Start-Up Procedure

1. Ensure all personnel entering the clean room are properly gowning and following clean room protocols.
2. Inspect the HVAC control panel to ensure all switches are in the off position before starting the system.
3. Turn on the HVAC system and verify that all air handling units (AHUs), fans, and filters are functioning properly.
4. Monitor initial readings of temperature, humidity, and pressure differential between clean rooms and adjacent areas.

4.2 Operation

1. Regularly monitor and adjust the HVAC system settings as necessary to maintain specified clean room conditions (temperature, humidity, air exchange rate).
2. Check and record environmental parameters hourly or as per the monitoring schedule.
3. Respond promptly to any alarms or deviations in environmental conditions by investigating and taking corrective actions.
4. Ensure that the HVAC system is maintained in operation during production activities, and any planned shutdowns are communicated and scheduled appropriately.

4.3 Shutdown Procedure

1. Gradually reduce HVAC system operation to allow for proper air balance and pressure equalization.
2. Switch off all HVAC components systematically, starting with fans and ending with control panels.
3. Document the shutdown procedure and any observations in the logbook.

4.4 Maintenance

1. Perform routine preventive maintenance tasks as per the maintenance schedule, including filter replacement, coil cleaning, and lubrication of moving parts.
2. Calibrate temperature, humidity, and pressure sensors according to the calibration schedule.
3. Address any equipment malfunctions or deviations promptly and document corrective actions taken.

5) Abbreviations, if any

AHU: Air Handling Unit

6) Documents, if any

1. Operational logbook
2. Maintenance records
3. Calibration certificates

7) Reference, if any

GMP Guidelines for pharmaceutical manufacturing facilities and HVAC systems.

8) SOP Version

Version 1.0