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Çë´ó¼ÒÊÜÀÛ¸ø·ÒëÏ 55 BIOLOGICAL INDICATORS¡ªRESISTANCE PERFORMANCE TESTS D-VALUE DETERMINATION Conduct all the tests described in this section under aseptic conditions, using sterilized equipment for nonthermophilic microorganisms. D-value determination for G. stearothermophilus and B. coagulans can be performed in a controlled but unclassified environment. Apparatus The test equipment for the determination of microbial resistance is described in substantial detail in ISO 18472, Sterilization of Health Care Products¡ªBiological and Chemical Indicators¡ªTest Equipment.1 The details of individual Biological Indicator Evaluation Resistometers (BIERs) vary with the specifics of their design and the particular sterilization process in conjunction with which they are used. Provided that the performance of the BIER vessel meets the requirements of the ISO standard for exposure of the biological indicator, design differences are acceptable. Procedure Carry out the tests for D value at each of the applicable sets of sterilization conditions for which the packaged biological indicator under test is labeled for use. Take a sufficient number of groups of specimens of biological indicators in their original individual containers, each group consisting of not less than 5 specimens. The number of groups provides a range of observations from not less than one labeled D value below the labeled survival time through not less than one labeled D value above the labeled kill time. Place each group on a separate suitable specimen holder that permits each specimen to be exposed to the prescribed sterilizing condition at a specific location in the sterilizing chamber of the BIER. Check the BIER apparatus for operating parameters using specimen holders without specimens. Select a series of sterilizing times in increments from the shortest time for the specimens to be tested. The differences in sterilizing times over the series are as constant as feasible, and the difference between adjacent times is no greater than 75% of the labeled D value. |
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