PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Volume 14 , Issue 2
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Regular Article
  • Hirohito KATAYAMA, Kakuji YOSHIHARA, Hiroki SAITO, Masayuki AKUTAGAWA, ...
    2012 Volume 14 Issue 2 Pages 43-47
    Published: 2012
    Released: December 29, 2012
      One of the most important control points for sterile products as typified by parenteral injections is microbial control. Recently rapid determination for microbe is in the public limelight. First, we marshalled essential qualification to monitor microbes according to each clean area. Then, we evaluated how effectively the new determination method can be used based on actual data on several experiments. As a result, we found that the rapid determination for microbes is very useful. We assume that the usage of this technology is becoming more widespread in the near future.
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