USP-55生物指示剂-抗性测试分析.docVIP

USP 55 BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS 生物指示剂－抗性测试 TOTAL VIABLE SPORE COUNT 活孢子数总数计数 Remove three specimens of the relevant biological indicator from their original individual containers. Disperse the paper into component fibers by placing the test specimens in a sterile 250-mL cup of a suitable blender containing 100 mL of chilled, sterilized Purified Water and blending for 3 to 5 minutes to achieve a homogeneous suspension. Transfer a 10-mL aliquot of the suspension to a sterile, screw-capped 16- × 125-mm tube. 从生物指示剂的原包装袋中取出3支作为样本。把待测样品放入一个已灭菌的250mL有搅拌器的杯子里，杯子内装100 mL放冷的灭菌纯化水。把杯子里的纸片磨碎成纤维状，并混合3～5min使之成为均一的悬浮液。转移10ml的整数倍的悬浮液至一个已灭菌的16 × 125mm的螺盖管中。 For Biological Indicator for Steam Sterilization, Paper Carrier, heat the tube containing the suspension in a water bath at 95 to 100 for 15 minutes (heat shock), starting the timing when the temperature reaches 95. 如果是纸载的蒸汽灭菌生物指示剂，则把装有悬浮液的管放入95℃～100℃水浴15min（热休克），在悬浮液温度达到95℃时开始计时。 For Biological Indicator for Dry-Heat Sterilization, Paper Carrier, and for Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier, heat the tube containing the suspension in a water bath at 80 to 85 for 10 minutes, starting the timing when the temperature reaches 80. Cool rapidly in an ice water bath at 0 to 4. 如果是纸载的干热灭菌生物指示剂及环氧乙烷灭菌生物指示剂，则把装有悬浮液的管放入80℃～85℃水浴10min，在悬浮液温度达到80℃时开始计时。在0℃～4℃冰浴中迅速冷却。 Transfer two 1-mL aliquots to suitable tubes, and make appropriate serial dilutions in sterilized Purified Water, the dilutions being selected as calculated to yield preferably 30 to 300 colonies, but not less than 6, on each of a pair of plates when treated as described below. 转移2个1ml的悬浮液到合适的试管，用灭菌纯化水进行适宜的系列稀释，所选稀释液要求在进行下述操作后能达到30～300CFU／皿，但不少于6 CFU／皿。 Where the biological indicator has a low spore concentration, it may be necessary to modify the dilution series and to use more plates at each dilution. Prepare a separate series of plates for each aliquot. Place 1.0 mL of each selected dilution in each of two 15-