Standard Operating Procedure for Laminar Flow Hood
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Laminar Flow Hood used in the pharmaceutical manufacturing of otic dosage forms to ensure a contamination-free environment during critical processing steps.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Laminar Flow Hood in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Laminar Flow Hood as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying the performance of the Laminar Flow Hood.
Maintenance Personnel: Responsible for maintaining the Laminar Flow Hood in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Laminar Flow Hood for cleanliness and integrity before use.
4.1.1.2 Ensure that the HEPA filter is intact and functioning properly.
4.1.1.3 Verify that the airflow indicator is operational and within acceptable limits.
4.1.2 Preparation
4.1.2.1 Clean the work surface and interior of the Laminar Flow Hood using an approved disinfectant.
4.1.2.2 Allow the hood to
4.1.2.3 Arrange all materials and equipment needed for the operation inside the hood to minimize disruptions during work.
4.2 Operation
4.2.1 Working in the Hood
4.2.1.1 Perform all operations at least 6 inches inside the hood to maintain proper airflow.
4.2.1.2 Avoid placing hands or objects above the critical work area to prevent contamination.
4.2.1.3 Minimize rapid movements that could disrupt the laminar airflow.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE, including gloves, lab coat, and face mask, when working in the Laminar Flow Hood.
4.2.2.2 Follow aseptic techniques to prevent contamination of materials and the work environment.
4.2.2.3 Do not block the airflow grills with equipment or materials.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Remove all materials and equipment from the hood.
4.3.1.2 Clean the work surface and interior of the hood with an approved disinfectant.
4.3.1.3 Turn off the hood after ensuring that all work has been completed and the hood has been cleaned.
4.3.2 Maintenance
4.3.2.1 Regularly inspect the HEPA filter and replace it as per the manufacturer’s recommendations.
4.3.2.2 Monitor the airflow indicator and ensure it is within acceptable limits.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
HEPA: High-Efficiency Particulate Air
6) Documents, if any
Maintenance records
Airflow monitoring records
Cleaning logs for the Laminar Flow Hood
7) Reference, if any
Manufacturer’s manual for the Laminar Flow Hood
Pharmacopeial guidelines for cleanroom and biosafety cabinet operations in pharmaceutical manufacturing
8) SOP Version
Version 1.0