Illuminating Hidden Risk in Pharmaceutical Manufacturing cGMP Contamination Control
Pharmaceutical manufacturers operating under cGMP requirements must balance effective contamination control with growing expectations for material and product protection. Compliance with the cGMPs often drives the use of cleanroom covers to protect critical process components. This can include light sensitive products and active pharmaceutical ingredients (APIs) throughout the manufacturing lifecycle.
Join this complimentary webinar to learn how STERIS equipment covers and bag offerings support cGMP compliance and material protection for applications sensitive to light exposure. Gain insight into the regulatory rationale behind these approaches, including how protective materials may be used to shield light sensitive components and APIs during manufacturing. Explore where cGMP-related protection gaps may occur during pre packaging handling and storage and how sterility maintenance protection fits within an overall contamination control strategy.
Meet the Presenters
Renee Buthe
Renee has nearly a decade of industry experience in cell and gene therapies, including generating environmental monitoring protocols, performing airflow visualization studies and aseptic process simulations, reviewing batch records and authoring final reports.
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At STERIS Life Sciences, Renee assists Customers with sterility assurance and sterility maintenance product applications, providing consultation on product usage and contamination control best practices.
Renee is an active member of the Parenteral Drug Association (PDA) and serves as an instructor through the PDA Training Institute, contributing to industry education and professional development.
Stephen Knox
Stephen has over a decade of experience in product management, with expertise in portfolio strategy, lifecycle management and Customer focused product development.
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He holds a bachelor’s degree in marketing from La Salle University and a master’s degree in business management from DeSales University.
At STERIS Life Sciences, Stephen leads portfolio management and new product development for sterility maintenance products. His work supports Customers in maintaining sterility throughout storage, handling and use in regulated environments, with a focus on aligning product strategy to Customer needs and regulatory expectations.
Stephen also contributes to Customer education through events and technical documentation, helping them stay informed on sterility maintenance requirements, implementation challenges and evolving industry expectations.
Tiffany Bullock
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.
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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).
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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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