PDA Journal of Pharmaceutical Science and Technology: 73 (2)

March/April 2019; Volume 73,Issue 2

Editorial

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Editor's Note
Richard Levy

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 110; DOI: https://doi.org/10.5731/pdajpst.2019.001112

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Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl and Alexander Streubel

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 111-120; DOI: https://doi.org/10.5731/pdajpst.2018.008870
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Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke and Dawood Dassu

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 121-134; DOI: https://doi.org/10.5731/pdajpst.2018.008722
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Application of Arrhenius Kinetics to Acceleration of Controlled Extraction Studies
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 135-169; DOI: https://doi.org/10.5731/pdajpst.2018.009050

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Container Closure Integrity Testing—Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
Jonas Olsen Hede, Philip Loldrup Fosbøl, Signe Willestofte Berg and Søren Dahl

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 170-180; DOI: https://doi.org/10.5731/pdajpst.2018.008680

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How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 181-190; DOI: https://doi.org/10.5731/pdajpst.2018.008938
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Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing
Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe and Stacy L. Springs

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 191-203; DOI: https://doi.org/10.5731/pdajpst.2018.008862

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Cleaning Validation: Complete Guide for Health - Based Approach in Chemical Cross - Contamination Risk Assessment
Joseph N. Tanyous

PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 204-210; DOI: https://doi.org/10.5731/pdajpst.2018.008946