Sterility assurance

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A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
Kelly Waldron, Amanda McFarland, Hal Baseman and Maik Jornitz

PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 88-97; DOI: https://doi.org/10.5731/pdajpst.2024-003038.1
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The Use of Amplified ATP Bioluminescence for Rapid Sterility Testing of Drug Product Formulations
Miriam Guest, Benjamin Pickard, Benjamin Smith and Sophie Drinkwater

PDA Journal of Pharmaceutical Science and Technology September 2023, 77 (5) 402-411; DOI: https://doi.org/10.5731/pdajpst.2022.012762
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Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology
R van der Galiën, A. L. Langen, L. J. M. Jacobs, B. Hagen, K. Flahive, S. D. Chatterjee and M. C. van Amsterdam

PDA Journal of Pharmaceutical Science and Technology July 2023, 77 (4) 317-328; DOI: https://doi.org/10.5731/pdajpst.2022.012783
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Parametric Release of Moist Heat Sterilized Products: History and Current State
Michael J. Sadowski and Stephen E. Langille

PDA Journal of Pharmaceutical Science and Technology November 2022, 76 (6) 527-536; DOI: https://doi.org/10.5731/pdajpst.2022.012740
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Sterility Assurance—Current and Future State
Edward C. Tidswell, James P. Agalloco and Radha Tirumalai

PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 263-277; DOI: https://doi.org/10.5731/pdajpst.2020.012526
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Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality
Gerald McDonnell, Hal Baseman and Lena Cordie-Bancroft

PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 553-570; DOI: https://doi.org/10.5731/pdajpst.2021.012706
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Wanted: Dead or Alive
James P. Agalloco

PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 458-464; DOI: https://doi.org/10.5731/pdajpst.2020.011478
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The Bugs Don't Lie
James P. Agalloco

PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 615-621; DOI: https://doi.org/10.5731/pdajpst.2019.009894
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Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction
James P. Agalloco

PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 261-268; DOI: https://doi.org/10.5731/pdajpst.2016.007104
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Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation
James P. Agalloco

PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 269-273; DOI: https://doi.org/10.5731/pdajpst.2016.007112

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Parenteral Drug Association, Inc.