In the first 6-months of 2018, fiftteen 503B Outsourcing Facilities were cited for smoke study issues. Airflow is critical in maintaining sterile conditions, as described in the FDA Guide on Aseptic Processing
In an aseptic process, the drug product, container, and closure are first subjected to sterilization methods separately, as appropriate, and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely high-quality environment (p. 2)
Proper design and control prevents turbulence and stagnant air in the critical area. Once relevant parameters are established, it is crucial that airflow patterns be evaluated for turbulence or eddy currents that can act as a channel or reservoir for air contaminants (e.g., from an adjoining lower classified area). In situ air pattern analysis should be conducted at the critical area to demonstrate unidirectional airflow and sweeping action over and away from the product under dynamic conditions. The studies should be well documented with written conclusions, and include evaluation of the impact of aseptic manipulations (e.g., interventions) and equipment design. Videotape or other recording mechanisms have been found to be useful aides in assessing airflow initially as well as facilitating evaluation of subsequent equipment configuration changes. It is important to note that even successfully qualified systems can be compromised by poor operational, maintenance, or personnel practices (p. 6) [Bold added by author].
A review of the posted 483 reports identified the following smoke study issues:
Performance Validation has over 5,500 hours of combined experience performing smoke study testing and have completed over 30 Smoke Study projects ranging from a single hood to a complete aseptic filling facility. Have a question on Smoke Studies, need to resolve smoke study issues, or need to schedule your next study? Contact Dalton Pierson Performance Validation’s Smoke Study Expert, or use our Contact us form and we will be happy to assist you with your Critical Airflow testing.