Bacillus pumilus strain GB34 is used as an active ingredient in agricultural fungicides. Growth of the bacterium on plant roots prevents
Rhizoctonia and
Fusarium spores from germinating.
Bacillus pumilus (ATCC 27142) may be utilized (as a
biological indicator or 'BI' for short) to monitor Gamma, Electron Beam (E-beam), or X-ray radiation sterilization processes. However, the relevance of this practice has dwindled rapidly in the last 30 years due to the discovery of wild-type organisms, like
Deinococcus radiodurans, that have proven to have higher
D-values and have unseated
B. pumilus as recognized worst-case radiation challenge organism. As such, the International Standards Organization (ISO) no longer recognizes
B. pumilus as a BI method of validation or routine monitoring of a terminal radiation sterilization process for medical devices labeled as 'sterile'. Instead, parametric means are recognized, using dosimetry to monitor delivered radiation dose. The dose is established using information about the number and types of viable microbes in/on the product and/or its sterile barrier system packaging. The industry term for these microbes as they relate to a sterile medical device is
bioburden. Bioburden information coupled with dosimetry and subsequent tests of sterility are collectively used to perform verification dose experiments, which validate the terminal radiation sterilization dose. This dose supports the sterility assurance level (SAL) claim made by the product and its manufacturer. Most medical devices possess an SAL claim of 10E-6, that is one-in-one-million probability of [at least] one microbe making it through the sterilization process. The unit of measure for radiation dose for this purpose is kilogray, and a common radiation sterilization dose is 25 kilogray (kGy); however less or more dose is also quite common, as backed by validation data.
See also •
Bacillus marinus •
Bacillus lentimorbus •
Bacillus oleronius == References ==