Smoke studies are a key to qualification, maintenance, and monitoring of an aseptic facility. Smoke studies are performed to visually confirm unidirectional airflow exiting High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters in a manufacturing cleanroom. The importance of this qualification is documenting the air flow characteristics in your International Organization for Standardization (ISO) Class 5 environment.
Video By: Youtube Channel Biosero
In the case of particle or an airborne contaminant in the air within your clean room, the smoke test will demonstrate where the contaminant will likely move. It is desired that the particle will be driven in one direction (unidirectional airflow) past the product path and towards the air returns. The addition of smoke is to help identify any problems in airflow. Qualified key characteristics are air flow moves away from the product path. Air should be flowing smoothly in one direction with no turbulence or eddies. Movement within the air stream, for example person manipulating materials or product, air disruptions should recover quickly to regain unidirectional flow.
The styles of smoke used in clean rooms are limited. Be careful when selecting a cleanroom fogger because there are many methods that are not suitable for a cleanroom installation. Some of these methods, such as glycol or glycerin-based smoke, are known to leave an oily residue on everything in test area equipment personnel and floor. Unpleasant breathing conditions can be difficult in tight areas. The benefits to this method are a more intense longer last smoke and a more portable machine. The more desirable smoke is the water vapor generated using Water for Injection (WFI) or deionized water heated and combined with Liquid Nitrogen or dry ice. The benefits are a cleaner work environment and the vapor is similar to a light cooling mist. There is no clean up after completion of the study. The disadvantages are the vapor dissipates quicker, making is difficult to capture larger areas. Both of these methods should be conducted with trained personnel with proper safety equipment.
Photography is an art all on its own. Unless this is a hobby for those involved, there is a natural artful inclination for persons responsible for filming. It can be very tricky to record in a cleanroom environment. Within a typical cleanroom it tends to be white all around, such as gowning and walls, creating a white on white effect. Reflections in the equipment and general stainless surfaces, can give the impression that the smoke in moving in a different direction. Ways around these problems are to film in a few different angles in order to present the actual airflow. Reducing the light in the room if possible or placing a dark plastic bag in the background helps the smoke to stand out more. Informing others around you of your study as to avoid disturbances such as walking in front of camera, background noise and chatter. Reflections in glass (windows) and other polished materials can be a disruption to the viewer when instead of watching the air flow characteristics, their attentions turn to reflections showing someone on a ladder or doing something on the floor. Narrations are an important part or the videos, which should include location, study number, date, process, and the room number.
Written By: Damon Kology, Validation Consultant
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