Microrite raises the bar when it comes to airflow visualization studies of cleanrooms, barrier systems and controlled environments. Our experts provide airflow visualization studies which document actual airflow patterns using our unique “Tracer Particle Visualization” techniques.
We specialize in creating suitable documentation designed to meet regulatory (FDA and EU) required In-situ air pattern analysis studies. Microrite’s airflow visualization studies are a class of their own. Microrite’s experts can also assist in using these studies to develop risk based environmental monitoring (EM) programs by providing guidance related to EM sample site selection from the data collected during the airflow visualization.
Microrite’s strategy for conducting airflow visualization aka smoke studies include:
- Use of Microrite’s proprietary equipment
- Tracer particle of correct buoyancy and longevity to accurately visualize actual airflow patterns
- Use of multiple cameras to capture the risk associated with eddy currents and deviant airflow patterns
- Use of particle measurement in conjunction with smoke study to identify critical control points for monitoring
- Simulation of equipment setup and assembly, aseptic connections, operations, transfer of components and product, as well as environmental monitoring interventions to understand their effects on actual airflow patterns
- Diagnose the effects of surrounding environments on critical areas
- Document evidence of airflow patterns with expert recommendations
Benefits of using this strategy for conducting airflow visualization aka smoke studies include:
- Identify barrier technology or critical environment design issues
- Prevent environmental monitoring excursions, media fill and product failures by identifying eddy currents and deviant airflow patterns which can be corrected and properly monitored to address risk
- Prevent data integrity issues by identifying and correcting poorly designed, constructed, maintained and integrated cleanrooms and barrier systems
- Determine if gowning strategies and practices are adequate to support operations in conjunction with facility and barrier system design and integration
- Evaluate aseptic manipulations and techniques in relation to airflow patterns