[What should be the length and inner diameter of the testing device for microbiological efficacy testing of formaldehyde gas sterilization methods?].

The series of tests described in a preceding publication (Spicher and Borchers, 1983) has been continued in a modified way. This time, the dependency of the microbiological test results of a formaldehyde gas sterilization procedure on length and inner diameter of the tubes serving as test pieces was examined. The tubes were 1 or 2 m in length with an inner diameter of 1 or 2 mm. The tests were performed with four different preparations of bioindicators. Spores of Bac. stearothermophilus served as test germs. The preparations differed in the type of suspension used for the preparation of the bioindicators: distilled water, diluted blood (10%), undiluted blood, 10% albumin solution. The spore suspensions had been dried on linen thread. During the test procedure, the bioindicators were located near the sealed end of the tube. After completion of the sterilization procedure, the bioindicators were examined for viable germs. In tubes of identical length, the frequency of indicators carrying viable germs was always higher in those of 1 mm than in those of 2 mm inner diameter. In tubes of identical inner diameter, the frequency of indicators carrying viable germs in those of 2 m length was always higher than in those of 1 m length. This regularity was independent of the type of bioindicators used. The bioindicators for the preparation of which a 10% albumin solution had been employed showed the highest resistance. A somewhat lower resistance was found for the bioindicators prepared with undiluted blood. The bioindicators for which the spores had been suspended in diluted blood proved to have the lowest resistance. If the spores had been suspended in distilled water, the resistance of the bioindicators was a little lower than that of those suspended in undiluted blood, but was higher than that of the dried spores with diluted blood. The test results confirm the effectiveness of the method proposed earlier, i.e. to deposit the bioindicators in special test pieces (e.g. tubes or sounds) for the microbiological testing of formaldehyde gas sterilization procedures. These test pieces must be at least as long and as narrow as the longest and narrowest cavity of the object to be sterilized (tubes, catheters). In order to standardize the microbiological testing of formaldehyde gas sterilization procedures and to guarantee a certain minimum efficiency, the bioindicator as well as the test piece and its size (length and inner diameter) should be standardized.(ABSTRACT TRUNCATED AT 400 WORDS)