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Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
Jennifer Anderson, Christopher Thompson, Kang Cai, Joshua Orchard and Gisela Ferreira

PDA Journal of Pharmaceutical Science and Technology January 2023, 77 (1) 27-37; DOI: https://doi.org/10.5731/pdajpst.2021.012674
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Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation
Sven Deutschmann, Mousumi Paul, Marja Claassen-Willemse, Jonas van den Berg, Pieta IJzerman-Boon, Viviane Grunert da Fonseca, Ellen Brunbech, Lynn Johnson, Chris Knutsen, Lucile Plourde, Joanny Salvas, Philip Villari, Lisa Wysocki and Margit Franz-Riethdorf

PDA Journal of Pharmaceutical Science and Technology January 2023, pdajpst.2021.012672; DOI: https://doi.org/10.5731/pdajpst.2021.012672
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Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
Robin Wagner, Peter Masatani, Dana Grace, Gianpiero Torraca, Stephanie Moore and David Semin

PDA Journal of Pharmaceutical Science and Technology December 2022, pdajpst.2021.012710; DOI: https://doi.org/10.5731/pdajpst.2021.012710
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An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
Jens Lamerz, Oana Mihaela Danila, Andreas Schuster, Janine Burren, Christian Moessner, Wolfgang Göhring, Pankaj Rege, Helmut Stahr, Stefan Hildbrand and Daniel Coleman

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 497-508; DOI: https://doi.org/10.5731/pdajpst.2021.012662
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A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems
Sven Deutschmann, Bill Carpenter, Caroline Duignan, Chris Knutsen, Joanny Salvas, Lisa Wysocki, Lucile Plourde, Lynn Johnson and Wolfgang Eder

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 509-526; DOI: https://doi.org/10.5731/pdajpst.2021.012646
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Interventions Risk Evaluation and Management in Aseptic Manufacturing
Hal Baseman, Subrata Chakraborty and Michael A. Long

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 485-496; DOI: https://doi.org/10.5731/pdajpst.2020.012245
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Tailored Media-Fill Test Protocols Inspired by ⁶⁸Ga Kit-Based Radiopharmaceuticals
Charlotte Donzé, Léa Rubira, Pierre Olivier Kotzki, Emmanuel Deshayes and Cyril Fersing

PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 416-433; DOI: https://doi.org/10.5731/pdajpst.2021.012657
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Microbial Contamination in Water Systems
Fritz Röder and Tim Sandle

PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 434-443; DOI: https://doi.org/10.5731/pdajpst.2021.012636
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Container Closure Integrity Test Method Development on Vials Stored at −80°C Using Headspace Carbon Dioxide Analysis
Ken Victor, Allison Alix Caudill and James Veale

PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 395-415; DOI: https://doi.org/10.5731/pdajpst.2021.012641
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Evaluation of the design, development, and performance of a mass-flow based, open-source buffer manufacturing system
Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee

PDA Journal of Pharmaceutical Science and Technology August 2022, pdajpst.2021.012660; DOI: https://doi.org/10.5731/pdajpst.2021.012660

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Parenteral Drug Association, Inc.