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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

July/August 2018; Volume 72,Issue 4

Editor's Note

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    PDA Forms Journal Editorial Board – Call for Volunteeers
    Richard Levy
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 347; DOI: https://doi.org/10.5731/pdajpst.2018.001108

Research

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    Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality
    Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert and Yuh-Fun Maa
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 348-366; DOI: https://doi.org/10.5731/pdajpst.2017.008326
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    Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
    Alejandra Nieto and Holger Roehl
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 367-381; DOI: https://doi.org/10.5731/pdajpst.2017.008391
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    Introducing the Alba® Primary Packaging Platform. Part 1: Particle Release Evaluation
    Alberto Chillon, Arianna Pace and Daniele Zuccato
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 382-392; DOI: https://doi.org/10.5731/pdajpst.2018.008623
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    Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long-Term Stability of Monoclonal Antibodies
    Lin M. Luis, Yuzhe Hu, Camellia Zamiri and Alavattam Sreedhara
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 393-403; DOI: https://doi.org/10.5731/pdajpst.2018.008581

Technology/Application

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    Ozone Generation during High-Voltage Leak Detection: Fiction or Reality?
    Sophie Becker, Kai Reimers, Volker Bickert and Martin Becker
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 404-410; DOI: https://doi.org/10.5731/pdajpst.2016.007153
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    Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals
    Andrew N. Antoszyk, Carl Baker, Jorge Calzada, Howard Cummings, Joanna So, Carlos Quezada-Ruiz and Zdenka Haskova
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 411-419; DOI: https://doi.org/10.5731/pdajpst.2017.008342

Case Study

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    The Role of Heat-Tolerant Endotoxin-Retentive Ultrafilters (UFs) for the Remediation of Reverse Osmosis (RO) Plants Employed for Surgical Hand Antisepsis Using Periodic Thermal Disinfection—A Ten Year Longitudinal Experience Study in the Operating Theater
    Yushi Uetera, Hiroshi Yasuhara, Naohito Kumada, Yoshiki Misawa, Yoshiyuki Terada, Yoshio Satou, Tamaki Suhara and Kunio Kawamura
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 420-437; DOI: https://doi.org/10.5731/pdajpst.2017.008482

Commentary

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    Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development
    Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan Mcvey, Nan-Xin Qian, Qingxiang Wei, Michael W. Laird, Yuan Zhu, Robyn Emmins, John A. Follit, Alison Porter, Andrew J. Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Hervé Broly, Frank Lee, Matthew Reeser, Jared Spidel, Karin Anderson, Christine Demaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R. Kumar and Tony Gill
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 438-450; DOI: https://doi.org/10.5731/pdajpst.2018.008789

Erratum

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    Erratum for John Mattila, Mike Clark, Shengjiang Liu, et al.: “Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration”
    John Mattila, Mike Clark, Shengjiang Liu, John Pieracci, Thomas R. Gervais, Eileen Wilson, Olga Galperina, Xinfang Li, David Roush, Konstantin Zoeller, Helene Brough and Christelle Simpson-Platre
    PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 451; DOI: https://doi.org/10.5731/pdajpst.2017.007963
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
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  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
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