Biological indicator design and efficacy evaluation parameters
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Abstract
In its most general definition, biological indicators are systems used in many different areas to control the effectiveness of the sterilization processes. Indicator of achieving the target of the sterilization process; it is to determine the performance of this process with specific indicators after the material and/or material exposed to the sterilization process are completely cleaned off the live microorganisms. With its most common usage, biological indicators are designed using bacterial spores that have been determined to be the most resistant to the sterilization method and are used when evaluating the effectiveness of the sterilization processes. It is expected that the SAL (Sterility Assurance Level) value should be 106 after the complete sterilization process. The design of the Biological Indicators is achieved by the absorbing bacterial spores on filter paper and placing them in a plastic tube. It consists of a glass ampoule with a color indicator to observe the growth of bacteria in the tube and a specially formulated culture medium for the growth of the relevant bacteria. In traditionally used biological indicators, the result can be reached in long periods such as 24 hours (steam), and 48 hours (ethylene oxide and moist heat), depending on the type of the indicator used. However, based on the recent studies, biological indicators that give in a very short time have been developed to overcome the time constraints. In this manuscript we are presenting a review on the biological indicators and novel approaches in this field.
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