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Smoke test is helpful to visualize the air flow pattern in sterile clean room areas.
The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the final product is free from contamination during processing.
The smoke study in cleanroom area is conducted to visually confirm unidirectional airflow exiting High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters in a manufacturing clean room.
The smoke study should be conducted by trained personnel with proper safety equipment. When performing the smoke study in clean room area, the styles of smoke used are limited, there are many methods that are not suitable for a clean room installation, some of these methods such as glycerin-based smoke are known to leave an oily residue on everything in test area equipment personnel and floor.
The smoke study in cleanroom area is important as it tells one about the airflow characteristics . it also demonstrates the movement of the particle in a clean room. Assuming there is a visible particle in the room, with all windows closed, an open door and the air conditioning system turned on.
Inadequate airflow might expose the drugs to the risk of product sterility.
The particle will be driven from the HEPA (high-efficiency particulate air), over the product in cleanroom equipment, the personnel involved, In case there is a particle or an airborne contaminant in the air within the clean room the smoke test will demonstrate where the contaminant will likely move.
Smoke studies are recommended during initial room qualification, new installation of equipment in the room, change in the equipment configuration, or any other changes in the existing systems. Since the main aim of performing the study in GMP cleanroom area is to observe the smoke that is produced to observe the airflow pattern within the room, therefore, the physical properties of the smoke play a very important role in the entire qualification.
The smoke should have a similar density to that of the air.
The smoke study in GMP clean room area must put into consideration all possible measures to ensure best results are achieved. It is therefore very important because if the results find unacceptable airflow, an investigation should be conducted to identify the main causes and provide possible solutions to be taken
smoke study shall be demonstrated at dynamic and static moreover the proposed interventions shall be performed to assess the flow of the air
