THE SUITABILITY OF COMMERCIAL BIOINDICATORS WITH SPORES OF BACILLUS-STEAROTHERMOPHILUS FOR TESTING THE EFFICACY OF FORMALDEHYDE STERILIZERS

Commercially available biological indicators with spores of B. stearothermophilus were investigated by the Hygiene-Institutes of Kiel and Lubeck. The objective was to find out if those indicators to which sheep blood was added subsequently correspond to the formaldehyde resistance required by. DIN 58948, part 14 (DIN 58948, part 13). Both working groups determined unanimously that the indicators of one producer showed a resistance too low compared to the remaining biological indicators showing a much higher resistance than required. Even biological indicators manufactored strictly in accordance to the testing standard were more resistant than demanded. This also corresponded to the commercially available untreated spores. On the other hand, practice showed that the biological indicators investigated within this study can be easily killed by formaldehyde sterilisators if they respond to the technical standard. In order to realize the testing of these sterilisators with indicators of a generally accepted resistance we propose either to demand for an equivalently higher formaldehyde resistance or to set up a killing period for the spore resistance from 150 to 240 min until experimentally important data are available. Concerning the blood containing indicators the results of both working groups differed considerably within the limits of formaldehyde efficiency whereas this was not the case with untested commercially available spores. As the addition of thinned blood did not cause an increase in resistance we recommend, in the interest of standardized investigative conditions, not to use it.