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Hideharu Shintani
Hideharu Shintani
1-10-60, Minamidaira, Hino, Tokyo 191-0041
Japan
Publications
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Research Article
Importance Considering Increased Recovery of Injured Microorganisms to Attain Reproducible Sterilization Validation
Author(s): Hideharu Shintani Hideharu Shintani
Final sterilization was conducted to health care products immediately prior to shipping and sterility assurance must be confirmed from the result of biological indicator (BI). The survived microorganisms after sterilization may be mostly injured microorganisms. The auxotrophic characteristics of injured microorganisms are different from those of healthy microorganisms. In that sense, the cultivation conditions of injured microorganisms must be used for confirming reproducible sterilization validation study, otherwise it may result in false negative at shipping test. This is important to attain correct and reproducible sterility assurance. This is indispensable to attain safety assurance of health care products. The evaluation of several sorts of agents must be studied to recover injured microorganisms and support growth reproducibly. It is also important to study for diminishing variatio.. View More»
DOI: 10.4172/2153-2435.1000210