Abstract
Terminal sterilization is considered the preferred means for the production of sterile drug products as it affords enhanced safety for the patient because the formulation is sterilized in its sealed, final container. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is the notion that destruction of a high population of a resistant biological indicator microorganism is required. More contemporary thinking on sterilization acknowledges that the bioburden is the actual target in sterilization and its destruction must be assured. In the application of low temperature moist heat for terminal sterilization especially subsequent to aseptic processing establishing the pre-sterilization bioburden to consider has proven challenging. Environmental monitoring survey data has determined identity of potential microorganisms but not their resistance to sterilization. This review article provides information on the moist-heat resistance of vegetative and sporeforming microorganisms that might be present. The first manuscript in this series provided the overall background, and describes the benefits to patient, producer and regulator of low-temperature moist-heat for terminal sterilization. The second manuscript outlined validation and operational advice that can be used in the implementation. This final effort concludes the series and provides insight into potential bioburden and its resistance
- Received February 13, 2017.
- Accepted March 29, 2017.
- Copyright © 2017, Parenteral Drug Association
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