Developing a Contamination Control Strategy (CCS) for Advanced Therapy Medicinal Products (ATMP) Cleanrooms
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.
Alexis Stachowski
Alexis Stachowski is an accomplished microbiologist with extensive experience in quality assurance and microbiology within the pharmaceutical and biotechnology industries.
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Currently, Alexis serves as the Associate Director of Quality Assurance Microbiology for biologics at Regeneron Pharmaceuticals in Rensselaer, NY. In this role, Alexis is responsible for enhancing and maintaining the facility’s bioburden program (contamination control), leading microbial contamination investigations, and ensuring compliance with industry standards for microbial control and mitigation. Alexis also provides strategic input on technology transfer plans and the development of microbiological methods and action limits.
Prior to joining Regeneron, Alexis held several key positions at Charles River Laboratories in Memphis, TN, including Senior Manager of Sterility Assurance and Quality Control Microbiology. During this time, Alexis managed the Contamination Control Strategy for an ATMP multi-product facility, oversaw environmental monitoring programs, and served as a subject matter expert for regulatory inspections by agencies such as the FDA and EMA.
Alexis’s career began at Cognate BioServices, where she progressed from Microbiologist to Manager of Quality Control Microbiology. At Cognate, Alexis supervised laboratory activities, developed microbiological quality policies, and provided expert consultation on microbiological assays and techniques.
In addition to their professional roles, Alexis is an active member of the Parenteral Drug Association (PDA), where they serve as a trainer for courses on aseptic processing and environmental monitoring.
With a strong background in microbiology and a proven track record in quality assurance, Alexis is dedicated to advancing microbial control practices and ensuring the highest standards of product safety and efficacy in the pharmaceutical industry.
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.
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