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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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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
Jump to section
- 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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