Strengthening Contamination Control Through Risk-Based Material Transfer
Virtual
Loading component...
Material transfer plays a critical role in any contamination control strategy (CCS). When introducing items or equipment into critical environments, including cleanrooms, airlocks, Restricted Access Barrier Systems (RABS) and isolators, a risk-based approach is essential to minimize contamination risks and maintain the integrity of your environment.
Join our complimentary webinar to learn how to evaluate material transfer requirements using practical risk assessment strategies. Explore key criteria to determine what can and cannot enter your critical environment and how these decisions can help prevent contamination from fungi, viruses, spores and vegetative bacteria.
Through practical examples and case studies, you’ll gain actionable insights into developing a robust CCS that supports compliance and effective material transfer practices.
This session will feature guest speaker, Alexis Stachowski, an accomplished microbiologist with extensive industry experience in microbiology and quality assurance.
Jim has over three decades of industry experience, with expertise in cleaning, disinfection, microbial excursions and disinfectant validation and testing.
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. 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 is an accomplished microbiologist with extensive experience in quality assurance and microbiology within the pharmaceutical and biotechnology industries.
Alexis Stachowski is an accomplished microbiologist with extensive experience in quality assurance and microbiology within the pharmaceutical and biotechnology industries.
Currently, Alexis serves as the 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.
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.
Contact Us
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.
