Abstract
This review article will provide general guidance to product development scientists for the justification for the use of aseptic filling for sterile injectable products in the place of terminal sterilization using moist heat. The discussion is centered on the position of U.S. and European regulatory agencies on aseptic processing versus terminal sterilization, and regulatory actions—that is, 483 observations, warning letters, and product recalls—associated with a lack of sterility assurance of aseptically filled injectable products. Also discussed are the sterility assurance levels achieved using terminal sterilization and aseptic processing, sterilization processes used for terminal sterilization, compatibility of different product, product packaging and delivery systems with terminal sterilization, physicochemical stability of product during a terminal sterilization process, and storage during the product shelf life. The author believes that a better understanding of the options surrounding terminal sterilization will result in fewer products being aseptically filled.
- © PDA, Inc. 2014
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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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