The use of two or more microorganisms versus one microorganism in the carrier materials for biological indicators.
Specification for the preparation of a biological indicator (BI) using two or more microorganisms in the carrier material were deleted from the current ISO 11138 series and Working Draft 14161 because it was assumed that the resistances of the individual microorganisms would be affected by interference from the other microorganisms. This assumption is speculative only, and has not been supported by experimental evidence. To test its validity, the author carried out an experiment to determine the resistances of Bacillus subtilis and Bacillus stearothermophilus when used alone and together in BI carrier material. In total concentrations of 10(6) cfu/0.1 mL, the organisms were applied alone and together to filter paper and dried. After incorporation into the BI, the three preparations (B. subtilis alone, B. stearothermophilus alone, and both together) were subjected to ethylene oxide sterilization or to moist-heat sterilization using the procedures described in ISO 11138-2 or ISO 11138-3, respectively. Resistances were measured in terms of decimal reduction times (D values). The D values of the preparations were determined using the survival-curve method and the limited Spearman-Karber method in conjunction with a BI evaluator resistometer. The D values of the preparations did not differ significantly with either sterilization method, providing experimental evidence that, at least under these conditions, the presence of a second microorganism in the carrier material did not interfere with the resistance of the original microorganism.
Shintani
H
H
Section of Medical Devices, National Institute of Health Sciences, Tokyo, Japan.
D001412:Bacillus subtilis / Q000254:growth & development*; D002845:Chromatography / Q000379:methods; D015169:Colony Count, Microbial; D001411:Geobacillus stearothermophilus / Q000254:growth & development*; D007202:Indicators and Reagents; D015203:Reproducibility of Results; D013171:Spores, Bacterial; D013242:Sterilization / Q000379:methods*; D016019:Survival Analysis
D007202:Indicators and Reagents