Sterile drug products

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A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
Mariam Salamatian, Yvonne Gross, Magnus Stering, Thao Le Vinh and Ashira Bindels

PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2024.012990; DOI: https://doi.org/10.5731/pdajpst.2024.012990
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Test Process and Results of Potential Masking of Sterilizing-Grade Filters
Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz

PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
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Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann

PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387
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Preuse/Poststerilization Integrity Testing (PUPSIT): To Do or Not to Do?
Vivek Sheel Gupta, Jitendra Jindal, Ashawant Gupta and Nalini Kant Gupta

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 301-308; DOI: https://doi.org/10.5731/pdajpst.2018.009449

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