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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 July 2022, pdajpst.2022.012740; DOI: https://doi.org/10.5731/pdajpst.2022.012740
Michael J. Sadowski
1 Baxter Healthcare;
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  • For correspondence: mike_sadowski@baxter.com
Stephen E. Langille
2 ValSource
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  • For correspondence: slangille@valsource.com
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Article Information

pdajpst.2022.012740
DOI 
https://doi.org/10.5731/pdajpst.2022.012740
PubMed 
35840343

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received February 3, 2022
  • Accepted June 30, 2022
  • Published online July 15, 2022.

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  • You are currently viewing a previous version of this article (July 15, 2022 - 11:02).
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Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Michael J. Sadowski1,3 (mike_sadowski{at}baxter.com) and
  2. Stephen E. Langille2 (slangille{at}valsource.com)
  1. 1 Baxter Healthcare;
  2. 2 ValSource
  1. ↵* Corresponding author; email: mike_sadowski{at}baxter.com

Cited By...

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  • Toward Enhanced Machine-Based Release in X-ray Sterilization
    Damien Prieels, Cody Wilson, Florent Kuntz, Josef Mittendorfer, John Logar
    Biomedical Instrumentation & Technology 2024 58 1
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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Parametric Release of Moist Heat Sterilized Products: History and Current State
Michael J. Sadowski, Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2022.012740; DOI: 10.5731/pdajpst.2022.012740

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Parametric Release of Moist Heat Sterilized Products: History and Current State
Michael J. Sadowski, Stephen E. Langille
PDA Journal of Pharmaceutical Science and Technology Jul 2022, pdajpst.2022.012740; DOI: 10.5731/pdajpst.2022.012740
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  • Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
  • Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
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Keywords

  • Moist Heat Sterilization
  • Parametric Release
  • Process Control Release
  • Real Time Release
  • Sterility assurance
  • Sterility test

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