Standard Operating Procedure for Air Handling Unit (AHU)

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Air Handling Unit (AHU) used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Air Handling Units (AHUs) used to regulate and maintain air quality in clean rooms for the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, monitoring, and maintenance of the Air Handling Units (AHUs). 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 AHU control panel to ensure all switches are in the off position before starting the unit.
3. Turn on the AHU system and verify that all components (fans, filters, dampers) 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 AHU 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 AHUs are maintained in operation during production activities, and any planned shutdowns are communicated and scheduled appropriately.

4.3 Shutdown Procedure

1. Gradually reduce AHU operation to allow for proper air balance and pressure equalization.
2. Switch off all AHU 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 clean room HVAC systems.

8) SOP Version

Version 1.0