Single-use systems

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Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems
Klaus Wormuth, Fanny Gaston, Melanie Gauthier, Veronique Cantin and Nelly Montenay

PDA Journal of Pharmaceutical Science and Technology September 2023, pdajpst.2022.012755; DOI: https://doi.org/10.5731/pdajpst.2022.012755
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Challenges in the Manual Visual Inspection of the Interior Surfaces of Single-Use Systems for the Presence of Particulate Matter
Klaus Wormuth, Olivier Benoit, Dounia Kateb and Dany Laruelle

PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 332-340; DOI: https://doi.org/10.5731/pdajpst.2020.012211
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Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 677-712; DOI: https://doi.org/10.5731/pdajpst.2015.01077
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Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh and Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 590-619; DOI: https://doi.org/10.5731/pdajpst.2015.01073

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