Friedman noted that smoke studies should be planned ahead to have sufficient time to address any issues. The goal is aseptic processing line design for robust unidirectional air flow, and he noted that FDA inspections have increased emphasis on smoke studies to illuminate design weaknesses that pose contamination hazards. The air surrounding the aseptic processing line matters because airborne microorganisms in the filling environment can have a profound effect on the level of product contamination. Also important is gown quality and appropriate aseptic techniques, and written procedures should address when personnel should be retrained, requalified or assigned to other areas. Aseptic technique at all times is recommended to ensure maintenance of product sterility. This is the greatest source of contamination and even a successfully qualified system can be compromised by poor operational, maintenance, or personnel services, he said. “This is not a one-time only exercise,” he emphasized, since new risks may be identified in the lifecycle, and further improvements can be made to reduce risks.įriedman listed a range of variables that interact and can impact sterility assurance: aseptic processing line process (including personnel flow, material flow, and layout) HVAC/utilities response to deviations and environmental control trends disinfection procedures and practices QA and QC media fills people and facility and room. Know the risks, as well as the routes and sources of contamination, since it is hard to contain them if you don’t know about them, Friedman said. To prevent errors, identify “holes” in management, technology, processes, systems, and people, because deficits can lead to problems. They lead to satisfied customers (patients). Consistency is critical as is business dependability. Quality and supply are two keys, he said. ![]() Anticipate potential problems ahead of time, Friedman said, and establish the manufacturing infrastructure and quality governance to support these goals. Early emphasis on this is especially important for biotech and sterile manufacturing. Manufacturing reliability especially for aseptic starts with selecting the right design concept, he noted. Robust quality systems equal a state of control for aseptic facilities, and Friedman outlined the benefits: Sound lifecycle decision making use of scientific and risk-based approaches establishing and maintaining a state of process control, which designs reliable processes and products monitoring process performance and product quality and managing risk effectively to create real “fixes” to problems. Regulatory concerns include aging facilities-Friedman noted that some facilities at the heart of current drug shortages have been operating continually since the 1960s-and inspection reports suggest some manufacturing lines have had just limited upgrades. ![]() Friedman noted that Janet Woodcock, Director of CDER/FDA, has testified before Congress about the impact of old or obsolete facilities or process elements and operations with high defect rates in violation of cGMP. ![]() These problems have led to both drug defects and critical drug supply shortages. Improvement is needed in aseptic processing, especially in older facilities that may have poorly designed or maintained equipment because these lead to increased manual interventions that in turn raise the risk for microbial contamination. Modern facilities and technologies are needed, as are more highly skilled staff to support these, he noted. Looked at aseptic processing today and where further strides can be made. ASEPTIC EVOLUTIONįriedman’s opening plenary presentation, “The State of Aseptic Processing: Current Findings and Learnings,” 1, 2, 3, 4, 5 This article does not represent official guidance or policy of the FDA. Disclaimer: This is an abridged, unofficial summary of a presentation by an FDA regulator at an ISPE conference that has not been vetted by the agency.
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