Spore suspensions with a known D value should be used to inoculate the actual or simulated product. A simulated product is a preparation that differs in one or more ways from the actual product, but performs as the actual product using test conditions or during actual production sterilization processing. This represents an inoculated product however, a simulated inoculated product may be used if it is not practical to inoculate the actual product. Biological indicators may also be used to evaluate the capability of processes used to decontaminate isolators or aseptic clean-room environments.Īnother form of biological indicator is a spore suspension that is inoculated on or into representative units of the product to be sterilized. Biological indicators may also be used to monitor established sterilization cycles and in periodic revalidation of sterilization processes. Biological indicators are used in processes that render a product sterile in its final package or container, as well as for the sterilization of equipment, materials, and packaging components used in aseptic processing. A biological indicator can be used to assist in the performance qualification of the sterilization equipment and in the development and establishment of a validated sterilization process for a particular article. Microorganisms widely recognized as suitable for biological indicators are spore-forming bacteria, because, with the exception of ionizing radiation processes, these microorganisms are significantly more resistant than normal microflora. A biological indicator is broadly defined as a characterized preparation of a specific microorganism that provides a defined and stable resistance to a specific sterilization process.
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