[Dependency of a microbiological test of a formaldehyde gas sterilization procedure on the shape of objects to be...

During the last decade, a number of procedures have been developed by different firms for the sterilization of heat-sensitive instruments using a mixture of formaldehyde and water vapor at a temperature of approximately 60 degrees C as means of sterilization. Instruments to be sterilized by this technique as e.g. sounds and catheters normally have long narrow cavities. Therefore, the formaldehyde gas sterilization procedures have to be tested primarily for their capability of achieving a sufficient microbicidal effect within those cavities. For this purpose, the bioindicators are placed into special test pieces. The test pieces commonly in use differ widely in their construction, shape, and size. They mostly consist of some hollow cylinder with an attached capillary or a tube (see Table 1). The authors demonstrated by means of models that the variety of test pieces in use meant that the sterilization procedures had to meet quite different requirements. The models consisted of flexible tubes differing in diameter and length and were connected to short glass tubes. These glass tubes having identical or wider inner diameters than the flexible tubes served as receptacles containing the bioindicators. Spores of Bacillus stearothermophilus served as test organisms. The spores were suspended in defibrinated sheep blood and dried on filter paper. The efficiency of the sterilization technique was measured in terms of the relative number of indicator strips with surviving germs (i.e. non-sterilized indicators) after treatment of the test pieces with the formaldehyde gas. At first, the test results were examined as to their dependency on the length of the flexible tubes. These tubes were 3 mm wide and 5 to 100 cm long, each being sealed at one end and with the bioindicators placed near the sealed end. The percentage of indicators with surviving germs increased with the length of the tubes. After the sterilization process, nearly all indicators (92%) contained in the 1 m tubes proved to be non-sterile (see Table 2). The same results were obtained with tubes open at both ends, with the bioindicators located in the middle section of the tubes (see Table 3). Using tubes of 1 m length, the dependency of the test results on the inner diameter of the test pieces was demonstrated. While all indicators placed into tubes of 3 mm inner diameter still contained surviving germs, those in the tubes of 9 mm inner diameter were all sterile (see Table 4).(ABSTRACT TRUNCATED AT 400 WORDS)