Procedure for Airflow Visualization Studies
1) Purpose
The purpose of this SOP is to outline the procedure for conducting airflow visualization studies in cleanrooms to assess and validate the effectiveness of airflows in maintaining specified cleanliness levels.
2) Scope
This SOP applies to all cleanrooms and controlled environments within the facility, requiring periodic airflow visualization studies to ensure compliance with regulatory standards and internal specifications.
3) Responsibilities
Facility Engineering: Responsible for conducting airflow visualization studies.
Quality Assurance (QA) Department: Responsible for oversight and review of study procedures and findings.
4) Procedure
4.1 Study Preparation:
4.1.1 Review cleanroom classification and layout to identify critical areas for airflow visualization.
4.1.2 Ensure all HVAC systems and filters are operational and in compliance with maintenance schedules.
4.2 Tracer Release:
4.2.1 Prepare and release tracer particles or smoke generators at predetermined locations within the cleanroom.
4.2.2 Monitor and document the release process to ensure uniform distribution of tracers.
4.3 Visualization and Recording:
4.3.1 Observe and record the movement of tracer particles or smoke under steady-state conditions.
4.3.2 Use appropriate visualization tools (e.g., laser light sheets, thermal imaging) to track airflow patterns and turbulence zones.
4.3.3 Document findings with photographs, videos, or written descriptions.
4.4 Data Analysis:
4.4.1 Analyze recorded data to assess airflow uniformity, directionality, and potential dead zones or recirculation areas.
4.4.2 Compare observed airflow patterns against design specifications and cleanroom classification requirements.
4.4.3 Identify any deviations from expected airflow patterns and investigate potential causes.
4.5 Reporting:
4.5.1 Compile a comprehensive Airflow Visualization Study Report detailing study objectives, methodology, observations, and conclusions.
4.5.2 Submit the report to QA for review and approval.
4.5.3 Retain records of all airflow visualization studies in accordance with facility procedures and regulatory guidelines.
5) Abbreviations, if any
QA: Quality Assurance
HVAC: Heating, Ventilation, and Air Conditioning
6) Documents, if any
Airflow Visualization Study Report
HVAC System Maintenance Records
7) Reference, if any
ISO 14644-3 – Cleanrooms and associated controlled environments (Part 3: Test methods)
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0
