Smoke Study in Cleanroom Areas : Pharmaguideline

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Smoke Study in Cleanroom Areas

Smoke test is helpful to visualize the air flow pattern in sterile cleanroom areas. Smoke flows according to the flow of air in the area and shows its path.
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 in a processing company. 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 main objective of the smoke study is to observe the pattern that is introduced to observe the airflow pattern and therefore physical properties of the smoke play a visual role in the entire qualification. 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, therefore, one has to be careful when selecting a fogger because there are many methods that are not suitable for a clean room installation.

Smoke Test in Cleanroom Area
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 of the ISO (International Organisation for Standardisation) class 5 environment. The smoke study 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, one can clearly observe the direction in which the particle is moving within the room.

The particle will be driven from the HEPA (high-efficiency particulate air), over the product in cleanroom equipment, the personnel involved, the clean room floor and finally the place where the particle exit the room. 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. Inadequate airflow might expose the drugs to the risk of product sterility.

Advantages of Smoke Study in Cleanroom Area

The benefits of this method are more intense longer last smoke and a more portable machine. Another benefit is a cleaner work environment and the vapor is similar to a light cooling mist.

Disadvantages of Smoke Study in Cleanroom Area

The vapor dissipates quicker, making it difficult to capture larger areas.

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 to avoid any further damage from occurring currently or in future.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. what is type of hepa filter preferred to be used ?


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