Aseptic manufacturing facilities have many critical qualification activities that rely heavily on high-quality data collection. One such activity is critical airflow visualization – commonly referred to as a smoke study. Smoke studies are used to demonstrate “laminarity and sweeping action over and away from the product under dynamic conditions” (FDA draft guidance “Sterile Drug Products Produced by Aseptic Processing”).
The FDA guidance also states “it is crucial that airflow patterns be evaluated for turbulence or eddy currents that can act as a channel or reservoir for air contaminants.” The typical method of gathering data to verify the airflow is video recording the smoke study. This is an effective way to provide objective evidence that the room airflow meetings regulatory and organizational standards. Yet there are challenges with this method of data collection which can become data integrity concerns if not mitigated properly.
Data integrity on smoke studies is primarily maintained by well developed procedures, training, and quality hardware/software. If the objective evidence for the acceptability of the airflow is the video footage, then this becomes the raw data. Filming the study should account for capturing the best data possible. Video quality can be an issue here, and can be impacted by lighting, background, reflections and available camera angles. In fact, video quality can falsely identify airflow concerns where there are none. Also, during filming, unexpected events or “bloopers” may occur due to human error or some other anomaly.
For all of these data collection concerns, a tried and tested SOP and individuals well trained on that SOP are vital to ensure high-quality data is captured. Note taking during the study process is useful for identifying bloopers to address in final video production and to document other relevant information. Some organizations choose to have a qualified colleague act as witness during the execution of the smoke study for real-time viewing of the airflow. In this case, the video footage can be additional objective evidence, but not the primary acceptance criteria. Metadata, or “data about the data”, for a smoke study might be inserted into the video as a film placard. This can provide details on the scene such as who filmed the scene, where and when it was filmed, what it is intended to show (interventions, requirements). Data without metadata generally has little or lost meaning, which can be a data integrity problem.
Alteration of the raw data is clearly a data integrity concern. Once the smoke study is done, the data is usually transferred from durable media to an external hard drive. Cross checks of quantity of raw footage files and/or total file sizes should be used to ensure successful data transfer from the recording device media to the final storage location. During the final video processing, arrangement and compilation of the acceptable raw footage may be done to create a more audit-ready final video . Arranging and compiling is considered editing by some facilities and our ability to perform this depends on organizational requirements and risk tolerance. Obviously there is risk in removing any data from the study. Human error, but also misinterpretation of what constitutes a blooper, could jeopardize the data integrity and validity of the study. Raw footage video files should not be altered in any way.
Smoke studies are critical to cGMP compliance. Their success and quality hinge greatly on good practices (SOPs) and process. A best practice, from a data integrity standpoint, may be to adopt a process that includes a verification witness and to keep all raw data, including bloopers. Well trained smoke study professionals and tested checks-and-balances can ensure the study is valid and that the data can be trusted.
If you have a question on Data Integrity please contact Kevin Marcial. If you have a question on Smoke Studies please contact Dalton Pierson, or use our Contact Us form and one of Performance Validation’s team will be in touch.
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