放射線滅菌工程管理用Biological indicatorの安定性に関する検討

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In preparing Bacillus pumilus spore strips used for monitoring radiation sterilization, it is important for achieving uniform strip spore population to prevent spore aggregation in the spore suspension from which drops of uniform volume are taken by pipetting to be transferred to strips. When B. pumilus spores are suspended in water, settling preceded by stirring before pipetting has a distinct effect on achieving uniform spore population. When spores are suspended in 0.1% Tween 80 solution, uniform spore population is quite easily achieved.The effects of various storage temperatures on viability and radiation resistance of strip spores were tested using strips of uniform spore population.No appreciable change was observed in the number of viable spores on cellulose fiber strips even after 1 year storage at 5℃, 25℃ and room temperature (5 to 30℃). The number of viable spores on glass fiber strips decreased apparently after 100 days storage at 25℃ and room temperature, and after 1 year storage at 5℃.Fractional spore recoveries were measured by exposing spore strips to graded sublethal doses of gamma irradiation to measure D-value. D-value remained essentially unchanged even after 1 year storage at 5℃, 25℃ and room temperature for both cellulose fiber and glass fiber strips. The D-value found for cellulose fiber strips (3D/3=0.17〜0.18MR) is somewhat larger than that for glass fiber strips (3D/3=0.16〜0.17MR).
日本医療機器学会の論文
1985-06-01

放射線滅菌工程管理用Biological indicatorの安定性に関する検討

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