翻译 跪求
8.结论8.1各项产品的生菌数及回收率结果:8.1.1舒好血液回路成品平均生菌数361CFU/SIP(5套平均值)、回收率93.34%。8.2物理功能证明:全周期确认灭菌...
8. 结论
8.1 各项产品的生菌数及回收率结果:
8.1.1 舒好血液回路成品平均生菌数 361 CFU/SIP(5套平均值)、回收率93.34%。
8.2 物理功能证明:
全周期确认灭菌参数条件皆达成原订规格。
8.3 微生物去活功能证明:
8.3.1 灭菌产品中的生物指示剂,在灭菌完毕后,于无菌状态下将其取出,并将其内部玻璃层压破后,放于30~35℃的恒温培养箱中培养48小时。培养完毕后,生物指示剂颜色变为橙黄色。
8.3.2 利用全周期法:有测定点的生物指示剂皆呈阴性反应,可推得灭菌质量保证水平达10-6(SAL 达10-6)。
8.3.3 无菌试验培养14天,样品仍呈阴性反应。
9. 判定
以上的测试结果证明本灭菌周期使产品的SAL小于10-6,其灭菌效果判定为“可接受的”。 展开
8.1 各项产品的生菌数及回收率结果:
8.1.1 舒好血液回路成品平均生菌数 361 CFU/SIP(5套平均值)、回收率93.34%。
8.2 物理功能证明:
全周期确认灭菌参数条件皆达成原订规格。
8.3 微生物去活功能证明:
8.3.1 灭菌产品中的生物指示剂,在灭菌完毕后,于无菌状态下将其取出,并将其内部玻璃层压破后,放于30~35℃的恒温培养箱中培养48小时。培养完毕后,生物指示剂颜色变为橙黄色。
8.3.2 利用全周期法:有测定点的生物指示剂皆呈阴性反应,可推得灭菌质量保证水平达10-6(SAL 达10-6)。
8.3.3 无菌试验培养14天,样品仍呈阴性反应。
9. 判定
以上的测试结果证明本灭菌周期使产品的SAL小于10-6,其灭菌效果判定为“可接受的”。 展开
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8. Conclusion
8.1 The plate counts for each product and the recovery results:
8.1.1 Shu average finished good blood circuit plate count 361 CFU / SIP (5 sets of average), recovery of 93.34%.
8.2 The proof of the physical features:
Full validation of a sterilization cycle parameters are scheduled to reach specifications.
8.3 The proof of microbial deactivation features:
8.3.1 Sterilization of biological indicator products, after the sterile, sterile conditions in to remove it, and, after breaking its internal laminated glass, put in 30 ~ 35 ℃ constant temperature incubator 48 hours. After training, biological indicator color to orange.
8.3.2 Using the whole-cycle approach: a determination of the biological indicator points were highly negative, can push the level of sterilization quality assurance of 10-6 (SAL of 10-6.)
8.3.3 sterility test culture for 14 days, the sample continued to show a negative reaction.
9. To determine
The above test results show that the sterilization cycle, the product of the SAL is less than 10-6, and its sterilization effect judged as "acceptable."
8.1 The plate counts for each product and the recovery results:
8.1.1 Shu average finished good blood circuit plate count 361 CFU / SIP (5 sets of average), recovery of 93.34%.
8.2 The proof of the physical features:
Full validation of a sterilization cycle parameters are scheduled to reach specifications.
8.3 The proof of microbial deactivation features:
8.3.1 Sterilization of biological indicator products, after the sterile, sterile conditions in to remove it, and, after breaking its internal laminated glass, put in 30 ~ 35 ℃ constant temperature incubator 48 hours. After training, biological indicator color to orange.
8.3.2 Using the whole-cycle approach: a determination of the biological indicator points were highly negative, can push the level of sterilization quality assurance of 10-6 (SAL of 10-6.)
8.3.3 sterility test culture for 14 days, the sample continued to show a negative reaction.
9. To determine
The above test results show that the sterilization cycle, the product of the SAL is less than 10-6, and its sterilization effect judged as "acceptable."
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那是机器翻译的,最好人工翻译下
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