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Interventions Risk Evaluation and Management in Aseptic Manufacturing - A Case Study
Hal Baseman, Subrata Chakraborty and Michael K Long

PDA Journal of Pharmaceutical Science and Technology May 2022, pdajpst.2020.012245; DOI: https://doi.org/10.5731/pdajpst.2020.012245
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100% Control of Controlled Ice Nucleation Vials by Camera-Supported Optical Inspection in Freeze-Drying
Julian H. Lenger, Raimund Geidobler, Werner Halbinger, Ingo Presser and Gerhard Winter

PDA Journal of Pharmaceutical Science and Technology March 2022, 76 (2) 120-135; DOI: https://doi.org/10.5731/pdajpst.2020.012575
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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, Wolfgang Eder and Margit Franz-Riethdorf

PDA Journal of Pharmaceutical Science and Technology March 2022, pdajpst.2021.012646; DOI: https://doi.org/10.5731/pdajpst.2021.012646
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Container Closure Integrity Test Method Development on Vials Stored at -80°C Using Headspace Carbon Dioxide Analysis
Ken G Victor, Allison Alix Caudill and James Veale

PDA Journal of Pharmaceutical Science and Technology March 2022, pdajpst.2021.012641; DOI: https://doi.org/10.5731/pdajpst.2021.012641
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Microbial Contamination in Water Systems
Fritz Roeder and Tim Sandle

PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012636; DOI: https://doi.org/10.5731/pdajpst.2021.012636
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Tailored media-fill test protocols inspired by 68Ga kit-based radiopharmaceuticals
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PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2021.012657; DOI: https://doi.org/10.5731/pdajpst.2021.012657
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Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data when Screening for Extractables and Leachables by GC/MS?
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2021, pdajpst.2021.012673; DOI: https://doi.org/10.5731/pdajpst.2021.012673
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Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala and Andrew Barnett

PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 407-424; DOI: https://doi.org/10.5731/pdajpst.2020.011791
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Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies
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PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 425-444; DOI: https://doi.org/10.5731/pdajpst.2020.011676
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The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
Dennis Jenke and Ted Heise

PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 273-288; DOI: https://doi.org/10.5731/pdajpst.2020.012013

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Parenteral Drug Association, Inc.