PDA Journal of Pharmaceutical Science and Technology: 79 (2)

March/April 2025; Volume 79,Issue 2

Editorial

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Quality Assurance
PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 123-124; DOI: https://doi.org/10.5731/pdajpst.2025.001942

Research

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Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
Josiane Machado Vieira Mattoso, Luciana Veloso da Costa, Bruna de Almeida do Vale, Cristhiane Falavina dos Reis, Joyce Modesto de Andrade, Lygia Maria Paulo da Silva Braga, Greice Maria Silva da Conceição, Paulo Borges Mathias Costa, Igor Barbosa da Silva, Letícia de Alencar Pereira Rodrigues, Jeancarlo Pereira dos Anjos and Marcelo Luiz Lima Brandão

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 125-156; DOI: https://doi.org/10.5731/pdajpst.2023.012883
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A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu and Jeremy Guo

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 157-169; DOI: https://doi.org/10.5731/pdajpst.2023.012867
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Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
Massimo Guglielmi, Satoshi Arai, Peggy Georges, Amy Meysner, Peter Otton, Serena Panighello, Volker Rupertus, Jingwei Zhang and Daniele Zuccato

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 170-177; DOI: https://doi.org/10.5731/pdajpst.2024.012972
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A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
Hirohito Katayama, Manabu Tsuda, Yukari Koga, Nobuaki Habasaki, Kosuke Taniyama, Yuichi Minato, Akihiro Oda, Koichi Nagata, Takashi Amagasa and Kimitaka Misawa

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 178-192; DOI: https://doi.org/10.5731/pdajpst.2023.012911

Case Studies

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Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
Nolan Gunter, Yang Tang, Jonathan Ritscher and Yiming Peng

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 193-207; DOI: https://doi.org/10.5731/pdajpst.2024-003020
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Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
Ruben van der Galiën, Arjan L. Langen, Leon J. M. Jacobs, Prachi Sawant Raschdorf, Annie Xing and Irene M. C. van Amsterdam

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 208-217; DOI: https://doi.org/10.5731/pdajpst.2024-003018

Commentary

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Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
Vaibhav Deokar, Alok Sharma and Subrahmanyam M. Volety

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 218-235; DOI: https://doi.org/10.5731/pdajpst.2023.012873

Poster Abstract

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A User-Preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal Injections
Reza Abedian, Juergen Pfrang, Simon Buerdel, Nicole Forster and Sabine Websky

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 236-237; DOI: https://doi.org/10.5731/pdajpst.2025.25201
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Multiphysics Simulation of Needle Clogging in Pre-Filled Syringes
Joseph M. Barakat and Matthew Hancock

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 238-239; DOI: https://doi.org/10.5731/pdajpst.2025.25202
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Per- and Polyfluoroalkyl Substances (PFAS) in Primary Packaging and the Proposed Ban in the European Union
Taras T. Bredel, John Adamsen and Torben Helmer

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 240-241; DOI: https://doi.org/10.5731/pdajpst.2025.25203
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Sustainable Design for Healthcare Devices: Pathways Toward Net Zero
William J. Davies

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 242-243; DOI: https://doi.org/10.5731/pdajpst.2025.25204
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Nitrogen Dioxide Sterilization is a New State-of-the-Art Sterilization Technology to Control Contamination Risks From Your Prefilled Devices and Combination Drug Products
Annick Gillet, Aaron DeMent, Erik Haghedooren, Eric Offermann and Ross Tsakas

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 244-245; DOI: https://doi.org/10.5731/pdajpst.2025.25205
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Application of Modeling as a Tool for Early Derisking of Parenteral Delivery, from the Primary Container to the Tissue
Ludovic Gil, Christopher Basciano, Sean McGrath and Julien Singer

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 246-247; DOI: https://doi.org/10.5731/pdajpst.2025.25206
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Bridging the Gap—Ensuring Digital End-to-End PFS Integrity via an RFID-Based Seal: Holistic Digitalization of Inventory Management and Diversion Prevention of Hospital Drugs
Sebastian Muenscher

PDA Journal of Pharmaceutical Science and Technology March 2025, 79 (2) 248-249; DOI: https://doi.org/10.5731/pdajpst.2025.25207

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Parenteral Drug Association, Inc.