Developing a Contamination Control Strategy (CCS) for Advanced Therapy Medicinal Products (ATMP) Cleanrooms
To effectively control bioburden from entering cleanrooms and biological safety cabinets (BSCs), it is essential to implement a robust contamination control strategy (CCS) that supports the aseptic transfer of critical items into controlled environments.
Join this complimentary webinar to discover proactive strategies to prevent contamination from viruses, bacterial and fungal spores and vegetative bacteria. Explore real-world case studies from advanced therapy medicinal products (ATMP) cleanrooms and gain insights into bioburden control through high-risk transfer points. This session will also highlight published data that supports proven methods for maintaining aseptic conditions and protecting critical environments.
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.
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