Rapid Methods the Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing

Posted on February 16, 2022

Miriam Guest, Associate Principal Microbiologist, New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca
Sophie Drinkwater, Senior Scientist, New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca
Karen Capper, Head of Microbiology, New Modalities and Parenterals, AstraZeneca

Abstract The application of amplified ATP-Bioluminescence to determine the presence of microorganisms in pharmaceutical samples is an established alternative microbiological technique and has been applied to sterility testing. Within the international pharmacopoeias, a clear framework is provided to...

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