Abstract
Relationship between characteristics of bioburden and sterilization dose setting for disposable hypodermic needles, produced on same manufacturing lines, is presented in this study. The number of bioburden for 512 needles (18 lots) was changed from 0 to 6 and its distribution was extremely shifted to 0. Most of isolates (401 strains) were Gram positive cocci (60.3%) and spore forming bacteria (31.7%). The distribution of gamma radiation resistances (D 10) showed two peaks at about 1.1 kGy and 0.4 kGy. The sterilization doses estimated by Japan log formula method on the basis of above data became higher than those by AAMI B2 (UDS) and B3 methods.
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