A Methodological development of sterility testing and its use of full-enclosed filtration-culture ampoule system

摘要

The present invention is a kind of sterility test method, which selects strain, medium, prepares bacterial solution, records heat curves as fingerprint characteristics of each strain as identification features, obtains thermodynamic parameters of heat curves, and It is a sterility test method including the step of confirming the positive determination index of and performing the sterility test of the sample. The present invention introduces a hermetic agglomerate ampoule incubator used in the practice of this method, and the agglomerate ampoule incubator is composed of a bacterium ampoule system, a sample addition system and a peristaltic discharge system. The sample addition system and the bacterial ampoule system are connected via an entry tube. The present invention provides a microbial growth status curve for the entire detection process, the detection time of the microbial contamination is short, the level of precision and automation is high, the detection result is accurate. This curve provides a relatively good fingerprint-like property for analyzing the condition of the microorganisms, allowing accurate determination of microbial contamination.