Smoke Studies & Contamination Control

We provide specialized airflow visualization and smoke study services for pharmaceutical, biotechnology and healthcare environments, combining GMP contamination-control expertise with advanced engineering, fluid dynamics and experimental testing capabilities. Smoke studies are a critical tool for understanding and demonstrating how air moves within controlled environments. We support the design, execution and documentation of airflow visualization studies for cleanrooms, isolators, RABS, aseptic processing areas and other critical environments, with particular focus on sterile manufacturing and EU GMP Annex 1 expectations. Our studies are designed to provide clear evidence that airflow patterns effectively protect critical zones, exposed product and critical surfaces, while identifying potential risks associated with turbulence, reflux, stagnant areas, operator interventions, equipment configuration or interactions between different airflow regimes. More than visualization At ALLOVIS, smoke studies are not treated simply as a visual recording exercise. Our multidisciplinary expertise allows us to interpret airflow behaviour from both a GMP and an engineering perspective. By combining airflow visualization, fluid-dynamic expertise, CFD simulation, instrumentation and data acquisition, we can investigate complex airflow phenomena and help determine the technical root causes behind unexpected or potentially critical patterns. Where necessary, our Engineering team can support the evaluation of air velocities, pressure differentials, airflow distribution, HVAC performance and equipment configuration, providing additional quantitative data to complement the visual evidence generated during the smoke study. From study design to final documentation We support the complete smoke-study lifecycle, from initial assessment and study design through execution and final reporting. The approach is tailored to the specific facility, process and contamination risks and may include the definition of critical locations, interventions, operator movements, equipment configurations and representative operating conditions. Particular attention is given to dynamic conditions, ensuring that airflow behaviour is assessed not only under static conditions but, where applicable, during representative operations and interventions. Our support can include protocol preparation, risk-based scenario definition, smoke generation and visualization, professional video recording, technical evaluation of airflow patterns, deviation assessment and final GMP documentation. Supporting the Contamination Control Strategy The value of an airflow visualization study goes beyond qualification of an individual room or system. Results can provide important scientific evidence for the broader Contamination Control Strategy (CCS) and support the assessment of how facility design, HVAC systems, barrier technologies, personnel and operations interact to maintain contamination control. When weaknesses are identified, we help clients move from observation to solution through root-cause investigation, engineering assessment and practical risk-mitigation recommendations.