Who is USP The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP’s fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. Who are our Expert Volunteers? A hallmark of USP’s standards is that they are determined by independent scientific experts. USP Expert Volunteers are selected based on their individual expertise and experience and use their best personal, professional, and scientific judgment to work collaboratively on setting standards. USP Expert Volunteers must agree to disclose conflicts of interest and to uphold standards of conduct that preserve the integrity of the standard setting process. 2025-2030 Focus Area: The USP Expert Panel on Computational Fluid Dynamics (CFD) will develop scientifically sound and regulatory-aligned approaches to support the application of CFD in contamination control, with the long-term goal of reducing or replacing traditional airflow visualization studies. The panel’s deliverables will include drafting a USP standard (stimuli article and/or general chapter(s)) with an accompanying glossary, as well as contributing to the broader adoption of CFD through public workshops, peer-reviewed publications, and conference presentations. In addition, the panel will support education and knowledge dissemination by engaging with the USP Microbiology Committee through targeted presentations or internal workshops, ensuring alignment, awareness, and effective integration of CFD into current practices. 2025-2030 KEY ISSUES Airflow visualization studies are critical for understanding airflow patterns, contamination pathways, and the adequacy of aseptic controls, as well as for justifying environmental monitoring locations. However, they have significant limitations, including issues with particle neutral buoyancy, particle visibility and consistency, inadequate lighting, recording constraints, and reliance on human perception and interpretation. These limitations can compromise confidence in sterility assurance and the consistent delivery of sterile drug products. Computational Fluid Dynamics (CFD) offers a complementary approach by modeling and predicting airflow behavior, thereby improving accuracy, efficiency, and cost-effectiveness. CFD can enhance control strategies, including facility and process design, address persistent quality challenges, and ultimately support the reliable assurance of sterile drug supply. Required Expertise: • Strong background in CFD modeling, simulation, and validation • Experience with commercial and/or open-source CFD platforms • Deep understanding of airflow, particle behavior, and contamination pathways in controlled environments • Ability to translate complex CFD concepts into practical, regulatory-aligned guidance Additional Desired Preferences: • Hands-on experience with sterile drug product manufacturing (e.g., cleanrooms, isolators, RABS) • Experience applying CFD in pharmaceutical, biotech, or healthcare environments • Practical experience conducting or interpreting airflow visualization studies for comparison with CFD outputs • Familiarity with GMP requirements and guidelines (e.g., FDA, EMA, ISO cleanroom standards) • Experience contributing to standards, guidance documents, or industry best practices (USP, ISO, ISPE, PDA, etc.) • Expertise in HVAC systems, cleanroom design, airflow visualization, and environmental monitoring strategies Member Responsibilities • Explores specific compendial topic(s) and produces the deliverable(s) identified in the Expert Panel charge within a specific time frame • Performs assigned tasks and provides recommendations to the sponsoring Expert Body/Bodies • Provides final advisory recommendations in writing to the sponsoring Expert Body/Bodies • Strives to reach agreement with other members on compendial topics, although achieving unanimous agreement is not required • Participates in meetings (reads briefing materials, attends meetings, reviews minutes and notes, etc.) • Notifies USP staff of conflicts of interest; keeps disclosures up to date • A conflict of interest does not limit participation in discussions or the making of recommendations, provided the Expert Panel Member has disclosed this conflict. However, an Expert Committee Member who joins an Expert Panel is held to the move stringent conflict of interest requirements and Standards of Conduct applicable to an Expert Committee Member. • Develops and maintains awareness of fellow volunteers’ conflict of interest to help facilitate conflict of interest management • Disposes of any confidential materials at the conclusion of service • How will YOU create impact here at USP? In this role as a USP Volunteer, you contribute to USP’s public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.