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Review ArticleReview

Justification for the Use of Aseptic Filling for Sterile Injectable Products

Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 323-332; DOI: https://doi.org/10.5731/pdajpst.2014.00988
Anthony M. Cundell
Consulting Microbiologist, Scarsdale, New York, USA
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  • For correspondence: tonycundell@gmail.com
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References

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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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Justification for the Use of Aseptic Filling for Sterile Injectable Products
Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 323-332; DOI: 10.5731/pdajpst.2014.00988

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Justification for the Use of Aseptic Filling for Sterile Injectable Products
Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 323-332; DOI: 10.5731/pdajpst.2014.00988
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  • Article
    • Abstract
    • Introduction
    • U.S. and European Regulatory Agency Positions on Aseptic Processing Versus Terminal Sterilization
    • Product Recalls and Warning Letters
    • Categories of Product Generally Not Requiring Justification for Aseptic Processing
    • Demonstration of the Heat Instability of a Sterile Drug Product During Pre-formulation
    • Sterility Assurance Levels Achieved Using Terminal Sterilization and Aseptic Processing
    • Review of Drug Substance and Drug Product Stability As Applicable To Sterile Product Development
    • Conclusions
    • References
  • Figures & Data
  • References
  • Info & Metrics
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  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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