著者

HIDEHARU SHINTANI

出版者

The Society for Antibacterial and Antifungal Agents, Japan

雑誌

Biocontrol Science (ISSN:13424815)

巻号頁・発行日

vol.16, no.3, pp.85-94, 2011 (Released:2011-09-26)

参考文献数

6

被引用文献数

6 9

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Healthcare product manufacturers strive to provide safe, sterile products by validating and controlling manufacturing procedures. Validation study is the result of a multidisciplinary team effort. This successful effort relies on each discipline understanding the fundamentals of each technical disciplines and applying those fundamentals in terms of their own technical background. This paper is to introduce the basic concepts of sterilization methodology which are involved in validating various technical methods of sterilization and biological indicators (BIs). These will mainly address sterilization procedures in general terms and highlight on their microbiological aspects. The proper starting point is defining what sterility is and how it can be achieved through the validation studies by using BI.