Standard Operating Procedure for Using Laminar Air Flow
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the laminar air flow unit used in the manufacturing of otic dosage forms to ensure a sterile and contaminant-free environment.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the laminar air flow unit in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the laminar air flow unit as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the environment and ensuring sterility.
Maintenance Personnel: Responsible for maintaining the laminar air flow unit in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the laminar air flow unit is on a stable, level surface.
4.1.1.2 Check that the work area is clean and free of any debris.
4.1.1.3 Verify that the HEPA filter is properly installed and functioning.
4.1.2 Starting the Unit
4.1.2.1 Turn on the laminar air flow unit using the power switch.
4.1.2.2 Allow the unit to run for at least 15 minutes before starting any work to ensure proper air flow and sterility.
4.1.2.3 Check the air flow indicator to ensure the unit is operating within the specified range.
4.1.3 Working in the Laminar Air Flow Unit
4.1.3.1 Wear appropriate sterile clothing, gloves, and masks before working in the unit.
4.1.3.2 Place all materials and equipment inside the unit before starting work.
4.1.3.3 Perform all operations at least 6 inches inside the laminar air flow unit to ensure sterility.
4.1.3.4 Avoid any sudden movements that may disrupt the air flow and cause contamination.
4.1.4 Shutting Down the Unit
4.1.4.1 Remove all materials and equipment from the unit after completing the work.
4.1.4.2 Clean the work area with a suitable disinfectant.
4.1.4.3 Turn off the laminar air flow unit using the power switch.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the air flow indicator to ensure proper operation.
4.2.1.2 Record the results in the equipment log.
4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the laminar air flow unit monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.
4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the work area and the interior surfaces of the unit regularly with a suitable disinfectant.
4.3.1.2 Inspect the HEPA filter for any signs of damage or clogging and replace if necessary.
4.3.2 Troubleshooting
4.3.2.1 If the unit displays error messages or fails to maintain proper air flow, refer to the manufacturer’s manual for troubleshooting steps.
4.3.2.2 Contact maintenance personnel if the issue cannot be resolved.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
HEPA: High-Efficiency Particulate Air
6) Documents, if any
Air flow log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the laminar air flow unit
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0
