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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Identification of Micro-Organisms after Milliflex Rapid Detection—A Possibility To Identify Nonsterile Findings in the Milliflex Rapid Sterility Test

Jennifer C. Gray, Dieter Morandell, Günther Gapp, Nathalie Le Goff, Gunther Neuhaus and Alexandra Staerk
PDA Journal of Pharmaceutical Science and Technology January 2011, 65 (1) 42-54;
Jennifer C. Gray
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  • For correspondence: jennifer.gray@novartis.com
Dieter Morandell
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Günther Gapp
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Nathalie Le Goff
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Gunther Neuhaus
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Alexandra Staerk
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References

  1. 1.↵
    1. Gressett G.,
    2. Vanhaecke E.,
    3. Moldenhauer J.
    Why and how to implement a rapid sterility test. PDA J. Pharm. Sci. Technol. 2008, 62 (6), 429–444.
    OpenUrlAbstract/FREE Full Text
  2. 2.↵
    USP 〈71〉 Sterility Tests. Pharmacopeial Forum; USP 32–NF 27 through Second Supplement; United States Pharmacopeial Convention, Inc.: Rockville, MD.
  3. 3.↵
    2.1.6. Sterility. European Pharmacopoiea; Council of Europe: Strasbourg, France.
  4. 4.↵
    § 610.12. Sterility. 21 Code of Federal Regulations Chapter I (4-1-03 ed.).
  5. 5.↵
    1. Clausen O. G.
    A study of the growth-promoting properties of fluid and solid microbial-contamination test media on small numbers of microorganisms. Pharm. Acta Helv. 1973, 48 (10), 541–548.
    OpenUrlPubMed
  6. 6.↵
    1. McElroy W. D.
    The chemistry of light emission. Adv. Enzymol. Relat. Areas Mol. Biol. 1963, 25, 119–166.
    OpenUrlPubMed
  7. 7.↵
    1. Gray J. C.,
    2. Staerk A.,
    3. Berchtold M.,
    4. Hecker W.,
    5. Neuhaus G.,
    6. Wirth A.
    Growth-promoting properties of different solid nutrient media evaluated with stressed and unstressed micro-organisms: Prestudy for the validation of a rapid sterility test. PDA J. Pharm. Sci. Technol. 2010, 64 (3), 249–263.
    OpenUrlAbstract/FREE Full Text
  8. 8.
    1. Ohresser S.
    Encyclopedia of Rapid Microbiological Methods: ATP Bioluminescence Using Millipore's Milliflex Rapid System, 1st ed.; PDA: Bethesda, MD, 2005; pp 137–174.
  9. 9.↵
    USP 〈1223〉 Validation of Alternative Microbiological Methods. Pharmacopeial Forum; USP 32–NF 27 through Second Supplement; United States Pharmacopeial Convention, Inc.: Rockville, MD.
  10. 10.↵
    5.1.6. Alternative Methods for Control of Microbiological Quality. European Pharmacopoiea; Council of Europe: Strasbourg, France.
  11. 11.↵
    PDA technical report no. 33. The evaluation, validation, and implementation of new microbiological testing methods. PDA J. Pharm. Sci. Technol. 2000, 54 (3), 1–39 Supplement TR33.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 65 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 1
January/February 2011
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Identification of Micro-Organisms after Milliflex Rapid Detection—A Possibility To Identify Nonsterile Findings in the Milliflex Rapid Sterility Test
Jennifer C. Gray, Dieter Morandell, Günther Gapp, Nathalie Le Goff, Gunther Neuhaus, Alexandra Staerk
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 42-54;

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Identification of Micro-Organisms after Milliflex Rapid Detection—A Possibility To Identify Nonsterile Findings in the Milliflex Rapid Sterility Test
Jennifer C. Gray, Dieter Morandell, Günther Gapp, Nathalie Le Goff, Gunther Neuhaus, Alexandra Staerk
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 42-54;
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