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 experience in cleaning, disinfection, microbial excursions and disinfectant validation and testing.
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He holds a master’s degree in biology.
Prior to joining STERIS Life Sciences, Jim worked 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.
As a member of the STERIS Life Sciences team for the past 25 years, Jim’s current technical focus is on microbial control in cleanrooms and other critical environments. He conducts on-site training, webinars and high-level technical support for Customers in the biopharmaceutical industry.
As a 2019 Parenteral Drug Association (PDA) Michael S. Korczynski Award recipient, Jim was recognized for his contributions toward the development of PDA's international activities. Jim also received the 2024 PDA’s Distinguished Service Award for leading the PDA Missouri Valley Chapter for four years. He has given lectures around the globe on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. He has also published several PDA book chapters and articles related to cleaning, disinfection and contamination control.
Jim served four years as the President of the PDA Missouri Valley Chapter. He is also the current President Elect of the IEST Executive Board. He is 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 other industry associations.
Bruno Aze
With over 35 years of expertise, predominantly in the pharmaceutical industry, Bruno Aze is a results-driven expert in Good Manufacturing Practices (GMP), biosafety research and aseptic food and beverage production.
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As Global Senior Manager of Technical Services at STERIS Life Sciences, he spearheads cutting-edge innovations in Vaporized Hydrogen Peroxide (VHP™) solutions, ensuring continuous improvement and excellence in aseptic processing.
Bruno's deep expertise in process control, instrumentation and automation has led to groundbreaking advancements in VHP technology, driving several standardized integrations with Original Equipment Manufacturers (OEM) and establishing VHP as a building biodecontamination utility. His contributions have significantly elevated industry standards, enhancing efficiency, reliability and effectiveness in contamination control technologies.
Bruno is an active member of leading professional organizations, including the International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), A3P, Association for the Prevention and Study of Contamination (ASPEC) and Pharmapack.
He is deeply involved in shaping industry regulations and best practices. As a published author in respected industry journals and a frequent speaker at global conferences, Bruno shares insights into cutting-edge decontamination technologies and process optimization, solidifying his status 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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