Indianapolis, IN, February 13. Performance Validation (PV) a nationwide leader in providing commissioning, qualification, validation, and quality services to the pharmaceutical, biotechnology, and medical device industries will be attending and exhibiting at the 2018 ISPE Aseptic Conference in Reston, VA. Interested in learning how PV has assisted other aseptic manufacturers? Rick Van Doel, Ph.D., PV’s president will be at Booth 200 and available during the conference. Have a question, want to chat? either drop by the booth, or if you would like you may contact Rick to schedule a specific time to meet.
One of the key elements supporting aseptic processing is the ability to satisfactorily demonstrate proper airflow as necessary to protect the product during aseptic processing. As identified in the FDA Guidance Document Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing practice (p. 6)
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. [bold added by author]
Critical Airflow Visualization (smoke studies) are used to demonstrate proper airflow to protect the sterility of the product during aseptic operations. The studies should reflect actual practice i.e., what are the operations that the technicians will be performing in the ISO area. On review of the data (including the video recording) for acceptance if the data is inconclusive, shows turbulence, the time to intervene and correct the situation is now – not during an audit. The best systems can be invalidated through poor aseptic technique, improper gowning, poor maintenance, or failure to follow procedures.
Performance Validation has successfully performed critical airflow visualization or smoke testing in aseptic areas for many large pharmaceutical manufacturers (example summary) We can help you in designing the study to ensure the aseptic processing and interventions are identified and included in the testing. We can execute and document the study, and provide the documentation necessary to meet regulatory expectations.
If you are attending the event, please stop by Booth 200 to meet with Dr. Van Doel, PV’s President to learn more about our capabilities and how we might help with your next aseptic project. See you at the 2018 ISPE Aseptic Conference!