PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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Significance of Spore-Forming Bacterial Control—Bacterial Spores Characterization, Preparation, Methods for Determination of Heat Resistance, and Some Points described in JSP 14th Edition—
Kazuhito WATABE
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2001 Volume 3 Issue 2 Pages 67-73

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Abstract

  Bacterial spores, which are mainly produced by Bacillus and Clostridium in response to lethal environment, are well known as significantly dormant cell form. First, characterization of bacterial spores and preparation of them are briefly reviewed in this paper. Measurement of heat resistance issued in ISO is also described here. Because of their high resistance against chemical and physical treatments, sterilization of bacterial spores and valuation for sterilization methods should be considered. From this point, methods for sterilization and sterility tests concerning bacterial spores are partially modified or newly added in the recently issued JSP 14th edition, some of these items are briefly explained in this paper.

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© 2001 Parenteral Drug Association Japan Chapter
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