Join us at the 2026 ISPE Aseptic Conference to learn how a partnership with STERIS can strengthen your aseptic processing workflows. Improve operational efficiency and reduce risk to product and patient safety with our portfolio of sterility maintenance products.
Visit us in Booth #902 to connect with our team and learn how we can support your specific process needs.
At the show, don’t miss our technical presentations – see full details below.
Materials Transfer for Advanced Therapy Medical Product (ATMP) Cleanrooms
March 23, 2026
10:45 – 11:15
Presented by:
Jim Polarine – Principal Consultant, Technical Services
Alexis Stachowski – Regeneron Pharmaceuticals, Inc.
Explore contamination control strategies for materials transfer into ATMP cleanrooms, with a focus on risk assessment and best practices for decontaminating items entering Grade B cleanrooms and biological safety cabinet (BSC) hoods.
Stopper Bowl Management Case Study and Annex 1 Strategy
March 24, 2026
13:30 – 14:00
Presented by:
Bruno Aze – Principal Consultant, Technical Services
Giacomo Guidi – I.M.A. Industria Macchine Automatiche Spa
Learn how the new Annex 1 requirement for sterilizing all indirect product contact components under isolators and restricted access barrier systems (RABS) impacts contamination control strategies and explore joint industry findings and vaporized hydrogen peroxide (VHP) test results that address key process risks.
Meet the Presenters
Jim Polarine Jr.
Jim has over three decades of industry experience, with expertise in cleaning, disinfection, microbial excursions and disinfectant validation and testing. He also has experience as a Clinical Research Manager with the Department of Veterans Affairs in St. Louis, Missouri, and as a Biology and Microbiology Instructor at the University of Illinois and McKendree University.
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He holds a master’s degree in biology.
At STERIS Life Sciences, Jim focuses on microbial control in cleanrooms and other critical environments. He delivers onsite training, webinars and high-level technical support for Customers in the biopharmaceutical industry, helping guide best practices in contamination control and disinfectant validation.
Jim is a recognized industry contributor and award recipient. He received the Parenteral Drug Association (PDA) Michael S. Korczynski Award in 2019 for advancing PDA’s international activities and the 2024 PDA Distinguished Service Award for leading the PDA Missouri Valley Chapter for four years. He has presented globally on cleaning and disinfection, microbial control in cleanrooms and disinfectant validation and has published multiple PDA book chapters and articles on contamination control. Jim served four years as President of the PDA Missouri Valley Chapter and is the current President Elect of the IEST Executive Board. He is also an active member of the International Society for Pharmaceutical Engineering (ISPE), the American Society for Microbiology (ASM), the Society for Industrial Microbiology and Biotechnology (SIMB) and several other industry associations.
Bruno Aze
Bruno Aze has over three decades of industry experience, predominantly in the pharmaceutical sector, with expertise in Good Manufacturing Practices (GMP), biosafety research and aseptic food and beverage production. He has held senior technical leadership roles driving innovation and standardization in contamination control technologies.
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He holds a degree in electronics engineering and process and instrumentation.
At STERIS Life Sciences, Bruno leads innovation in Vaporized Hydrogen Peroxide (VHP™) technology and spearheads continuous improvement in aseptic processing. His deep expertise in process control, instrumentation, and automation has enabled standardized integrations with Original Equipment Manufacturers (OEM) and helped establish VHP as a building biodecontamination utility.
Bruno is an active member of leading professional organizations, including the International Society for Pharmaceutical Engineering (ISPE), the Parenteral Drug Association (PDA), A3P, the Association for the Prevention and Study of Contamination (ASPEC) and Pharmapack. He is deeply involved in shaping industry regulations and best practices and is a published author and frequent global speaker on decontamination technologies and process optimization, reinforcing his role as a thought leader in the field.
We’re Here for You
Your needs are unique – so is our approach. Discover how a partnership with STERIS can reduce risk and improve sustainability and efficiency at your facility.
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