PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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Development and an Application of a Temperature Multiplication Chemical lndicator
Toshiki FUJISAWA
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2003 Volume 5 Issue 1 Pages 55-59

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Abstract

  A temperature multiplication chemical indicator must change color by a temperature multiplication condition step-by-step. The chemical indicator of new development inspected performance evaluation with Steam CIER (Chemical indicator Evaluator Resistometer) Vessel. In addition, I let change of color performance of a chemical indicator and a change of central temperature of a standardized test pack used a normal steam sterilizer, and air exclusion rate change and inspected it. As a result, a thing having the performance that a chemical indicator changed color in a processing condition of 121°C and 134°C step-by-step of new development was inspected. I suggested that the system, which supposed an approximate sterility assurance level, used color-difference meter with this chemical indicator and could build it.

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© 2003 Parenteral Drug Association Japan Chapter
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