Abstract
The terminal sterilization of drugs and devices is the most appropriate means of assuring patient safety in terms of infection prevention. Adoption of terminal sterilization processes requires a supporting and thorough program for control and monitoring of bioburden, especially if a parametric release program of sterilization is desired. Such a control program should necessarily assess and evaluate the associated bioburden (primarily spores), which may resist inactivation and challenge the sterilization cycle. The bioburden resistance can be evaluated by several means and procedures (e.g., the boil test); however, these procedures should be designed and implemented taking into consideration the nature of the spore and spore recovery. This short review describes the application of moist heat resistance for the terminal sterilization of drugs.
LAY ABSTRACT: The terminal sterilization of drugs and devices is the most appropriate means of assuring patient safety in terms of infection prevention. Adoption of terminal sterilization processes requires a supporting and thorough program for control and monitoring of bioburden, especially if a parametric release program of sterilization is desired. This short review describes the application of moist heat resistance for the terminal sterilization of drugs.
- Microbiological tests
- Boil test
- Moist heat sterilization
- Terminal sterilization
- Overkill
- Bioburden
- Biological indicator
- Spores
- Spore inactivation
- Spore germination
- Spore outgrowth
- Bioburden control
- Parametric release
- © PDA, Inc. 2018
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