Abstract
This publication reviews the background that shaped the execution of moist heat for terminal sterilization across the global healthcare industry. Despite the clear benefits to patient safety afforded by terminal treatments, narrow regulatory expectations and misinterpretation of scientific principles progress towards broader implementation has been minimal. This paper outlines a means to expanded implementation addressing the need for balancing processing delivering sufficient lethality to reliably destroy the pre-sterilization bioburden while preserving the essential quality attributes of the product. This is accomplished by delivering the correct sterilization process with adjustments to the time-temperature conditions.
- Received October 31, 2023.
- Accepted July 25, 2024.
- Copyright © 2024, Parenteral Drug Association
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