Sterility

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Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
Michael W. Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D. Marlin, Matthew S. Huser, Henri Hebting and Lei Li

PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 303-319; DOI: https://doi.org/10.5731/pdajpst.2024.012941
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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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Risk Assessment Approach to Microbiological Controls of Cell Therapies
Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
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Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
Ken G. Victor, Lauren Levac, Michael Timmins and James Veale

PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 429-453; DOI: https://doi.org/10.5731/pdajpst.2017.007518
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Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus and Hanns-Christian Mahler

PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 313-324; DOI: https://doi.org/10.5731/pdajpst.2015.006080
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Non-Destructive Vacuum Decay Method for Pre-Filled Syringe Closure Integrity Testing Compared with Dye Ingress Testing and High-Voltage Leak Detection
Andrea Simonetti and Filippo Amari

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 108-122; DOI: https://doi.org/10.5731/pdajpst.2015.01004
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Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer and Lei Li

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 403-419; DOI: https://doi.org/10.5731/pdajpst.2012.00878

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Parenteral Drug Association, Inc.