A successful sterilization program extends beyond equipment selection and component preparation. To achieve effective, compliant outcomes, sterilization processes must be properly qualified, validated and routinely monitored.
Join the final webinar in our complimentary three-part series to learn how to approach sterilization process validation from both a regulatory and practical perspective. Explore the role of biological and chemical indicators and discover how load configuration, monitoring strategies and validation considerations work together to demonstrate process effectiveness and support regulatory compliance.
This session represents the final step in our examination of hard-goods sterilization for aseptic filling line components, highlighting how sterility assurance products and validation practices help confirm consistent, repeatable sterilization outcomes.
Tiffany has over a decade of experience in pharmaceutical microbiology, with expertise spanning sterility assurance, contamination control, environmental monitoring, sterilization, investigations and quality control test methods.
Tiffany has over a decade of experience in pharmaceutical microbiology, with expertise spanning sterility assurance, contamination control, environmental monitoring, sterilization, investigations and quality control test methods.
She has experience as a consultant in the pharmaceutical industry, supporting manufacturing organizations through quality control and quality assurance programs while collaborating with global regulatory agencies. She holds a bachelor’s degree in biological sciences with a minor in microbiology.
At STERIS Life Sciences, Tiffany conducts global manufacturing site evaluations and provides consultative support to help ensure compliance with international regulatory requirements. She also delivers global technical support for critical environments, sterility assurance activities and sterility maintenance application and validation.
Tiffany is an active member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE).
Alessia has nearly a decade of industry experience with expertise in sterilization, industrial washing and vaporized hydrogen peroxide (VHP) biodecontamination processes.
Alessia has nearly a decade of industry experience with expertise in sterilization, industrial washing and vaporized hydrogen peroxide (VHP) biodecontamination processes.
She has held roles supported process validation and product-process compatibility activities, including leading and coordinating cross-functional projects in compliance with Good Manufacturing Practices (GMP) standards and regulatory requirements. She holds a bachelor’s degree in biotechnology and a master’s degree in medical and pharmaceutical biotechnology.
At STERIS Life Sciences, Alessia is a member of the Technical Services team, where she provides support to Customers by applying her experience in sterilization and contamination control processes to address pharmaceutical manufacturing challenges. She also supports Customers through technical consultations and educational presentations.
Rose has half a decade of industry experience, with expertise in biology, microbiology and biological indicators.
Rose has half a decade of industry experience, with expertise in biology, microbiology and biological indicators.
She holds a bachelor’s degree in biology and a master’s degree in biology from Cleveland State University.
At STERIS Life Sciences, Rose supports the portfolio management and new product development of Sterility Assurance Products, collaborating across research and development, engineering, manufacturing, and quality functions to support Customer needs. Drawing on her scientific background and previous experience as an Associate Scientist on the biological indicator team, she supports product strategy and Customer education related to sterility assurance applications.
Rose has also contributed to published research in hematopoiesis and gene regulation.
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