盲管和生物指示剂安装对在线湿热灭菌工艺影响研究硕士论文.docxVIP

摘要研究背景：因为饱和蒸汽能在较短时间内有效杀死微生物及芽胞体，所以被广泛用 于灭菌工艺中。目前，蒸汽灭菌多集中于通过湿热灭菌柜对产品、材料和设备灭菌。 但是，由于尺寸和结构的限制，大量的工艺设备无法使用灭菌柜灭菌，而整个系统 的在线灭菌可以将无菌操作（如连接）的工作大幅降低甚至消除，所以被越来越广 泛的使用。本系统在对无菌灌装罐的在线灭菌测试过程中，位于无菌气体过滤器进气口的 生物指示剂挑战性实验失败。 研究目的：本文希望通过研究，找到位于无菌气体过滤器进气口的生物指示剂挑战 性实验失败的根本原因。 研究方法：本文首先通过因果分析法（鱼骨图分析法）对各层别类别找出所有可能 原因（因素）并选取重要因素, 再综合重要因素进行试验设计，最后实施试验，根据 实验结果对上述重要因素进行论证。 研究结果：通过因果分析法确定了盲管和生物指示剂的安装对湿热在线灭菌工艺造 成了重要的影响。通过实验设计及其实施验证了因果分析法（鱼骨图分析法）的结 论。研究结论：无菌过滤器入口处的三通是比较敏感的区域，生物指示剂的安装使其成 为关键的位置。在日常生产过程中，不会安装生物指示剂，这样就不会阻碍蒸汽的 流通和冷凝水的排净，因此这一敏感区域就会很好的被灭菌。虽然在过滤器前端的 灭菌效果不会破坏罐内的无菌状态，但是为了增加无菌保障，作为改进措施，会在 进气口的手动阀门前增加连通管，以确保手动阀门的灭菌效果。关键词：在线灭菌；湿热；生物指示剂；F 值；DT 值[Effect of Dead Leg and Bio Indicator Installation on Moist Heat Sterilization in Place Process]Background: because the microorganisms and spores can be killed effectively in a short time by saturated water steam, it is widely used in the sterilization process. Currently, steam sterilization is more concentrated in products, materials and equipment sterilization by autoclave. However, due to the limitation of size and structure, a large number of process equipment cannot be sterilized by autoclave. “Sterilization in place” can reduce or even eliminate the aseptic operation for the entire system, so it is used more and more widely. During the sterilization in place test for aseptic filling tank, the bio-indicator challenge test positioned at the inlet of an aseptic air filter failed.Purpose: this paper aims, through research, to find the root cause for the failed bio-indicator challenging test at the inlet of an aseptic air filterMethod: firstly, find out all possible causes (factors) and select the important factors by causal analysis (fishbone analysis), and then integrate all the important factors in the experiment design, and finally execute the experiment and demonstrate the important factors by experimental results.Result: through causal analysis (fishbone analysis), it is determined that the dead leg and bio-indicator installation have important