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Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Jonathan Cutting, Magali Barbaroux, Jean-Marc Cappia and Marie-Christine Menier

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 459-469; DOI: https://doi.org/10.5731/pdajpst.2018.009688
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Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process
Devon Roshan Eisner, Aaron Hubbard, Kirk Eppler, Vassia Tegoulia and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 443-458; DOI: https://doi.org/10.5731/pdajpst.2019.009928
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Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe and Louise Bennett

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 470-486; DOI: https://doi.org/10.5731/pdajpst.2018.009605
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Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael Carrier and Mariam Khan

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 418-432; DOI: https://doi.org/10.5731/pdajpst.2018.008953
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Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts
Richard Denk, Andreas Flückiger, Hirokazu Kisaka, Stephan Krause, Reinhold Maeck, Lars Restetzki, Andreas Schreiner and Rico Schulze

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 487-495; DOI: https://doi.org/10.5731/pdajpst.2018.009530
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Quality Risk Management Competency Model—Case for the Need for QRM Competencies
Ghada Haddad and Anne Greene

PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 331-344; DOI: https://doi.org/10.5731/pdajpst.2019.009944
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A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems—Part 2
Laura M. Doyle (Drbohlav), Anant Navanithan Sharma, Ganapathy Gopalrathnam, Lihua Huang and Scott Bradley

PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 320-330; DOI: https://doi.org/10.5731/pdajpst.2018.009639
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Measurement of Equilibration Time of Dry Goods Loads in Autoclaves
Soham Shah, Sara Alayli and Yiming Peng

PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 293-319; DOI: https://doi.org/10.5731/pdajpst.2018.009225
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Local Concentrating, Not Shear Stress, That May Lead to Possible Instability of Protein Molecules During Syringe Injection: A Fluid Dynamic Study with Two-Phase Flow Model
Lei Xing, Yue Li and Tonglei Li

PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 260-275; DOI: https://doi.org/10.5731/pdajpst.2018.009357
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Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation
Alberto Chillon and Daniele Zuccato

PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 235-246; DOI: https://doi.org/10.5731/pdajpst.2018.009423

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Parenteral Drug Association, Inc.