FDA and EMA Prefer Terminal Sterilization Over Aseptic Manufacturing ― Find Out Why
Advantages of Terminal Sterilization Over Aseptic Manufacturing
Regulatory agencies such as the FDA and EMA generally prefer terminal sterilization over aseptic manufacturing, as it provides a high level of sterility assurance. It is also less complex, less costly, more easily reproducible than aseptic manufacturing, and offers time savings to pharmaceutical companies.
In this issue of The Altascientist, we discuss:
- Differences between terminal sterilization and aseptic manufacturing
- Sterilization methods for pharmaceutical products
- Validation steps during sterilization
- Method selection
Read to learn how terminal sterilization can benefit your drug product.
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