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Research ArticleResearch

Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals

Masamitsu Izumi, Masato Fujifuru, Aki Okada, Katsuya Takai, Kazuhiro Takahashi, Takeshi Udagawa, Makoto Miyake, Shintaro Naruyama, Hiroshi Tokuda, Goro Nishioka, Hikaru Yoden and Mitsuo Aoki
PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 30-38; DOI: https://doi.org/10.5731/pdajpst.2015.005686
Masamitsu Izumi
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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  • For correspondence: Izumi.Masamitsu@otsuka.jp
Masato Fujifuru
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Aki Okada
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Katsuya Takai
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Kazuhiro Takahashi
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Takeshi Udagawa
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Makoto Miyake
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Shintaro Naruyama
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Hiroshi Tokuda
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Goro Nishioka
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Hikaru Yoden
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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Mitsuo Aoki
Sterilization Study Group, Intravenous Solutions Society, Tokyo, Japan
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References

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    Ministry of Health, Labour and Welfare of Japan. Yueki Working Group Hokokusho. Report from the Working Group of Large-Volume Parenterals, Pharmaceuticals, and Medical Devices committee, dated March 2, 2004 (in Japanese).
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    1. Pflug I. J.,
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PDA Journal of Pharmaceutical Science and Technology: 70 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 1
January/February 2016
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Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals
Masamitsu Izumi, Masato Fujifuru, Aki Okada, Katsuya Takai, Kazuhiro Takahashi, Takeshi Udagawa, Makoto Miyake, Shintaro Naruyama, Hiroshi Tokuda, Goro Nishioka, Hikaru Yoden, Mitsuo Aoki
PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 30-38; DOI: 10.5731/pdajpst.2015.005686

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Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals
Masamitsu Izumi, Masato Fujifuru, Aki Okada, Katsuya Takai, Kazuhiro Takahashi, Takeshi Udagawa, Makoto Miyake, Shintaro Naruyama, Hiroshi Tokuda, Goro Nishioka, Hikaru Yoden, Mitsuo Aoki
PDA Journal of Pharmaceutical Science and Technology Jan 2016, 70 (1) 30-38; DOI: 10.5731/pdajpst.2015.005686
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Keywords

  • Biological indicator
  • Bacillus oleronius
  • Bioburden
  • Terminal sterilization
  • Moist-heat sterilization
  • Large-volume parenteral solution

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