In-Process Microbial Testing: Statistical Properties of a Rapid Alternative to Compendial Enumeration Methods

References

1. 1.↵
   1. McCrady M. H.

   The numerical interpretation of fermentation-tube results. J. Infect. Dis. 1915, 17 (1), 183–212.

   OpenUrlFREE Full Text
2. 2.↵
   1. Halvorson H. O.,
   2. Ziegler N. R.

   Applications of statistics to problems in bacteriology. I. A means of determining bacterial population by the dilution method. J. Bacteriol. 1933, 25 (2), 101–121.

   OpenUrlFREE Full Text
3. 3.↵
   1. Cochran W.

   Estimation of bacterial densities by means of the “most probable number”. Biometrics 1950, 6 (2), pp 105–116.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Blodgett B.

   Appendix 2 of the FDA's Bacteriological Analytical Manual, 2010, (http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm109656.htm, accessed March 25, 2014).
5. 5.↵
   USP General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. United States Pharmacopeia, 37th Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2014.
6. 6.↵
   1. Miller M.

   J Case study of a new growth-based rapid microbiological method (RMM) that detects the presence of specific organisms and provides an estimation of viable cell count. Am. Pharm. Rev. 2012, 15 (2), 18–25.

   OpenUrl
7. 7.↵
   1. Ross S.

   A First Course in Probability, 2nd ed.; Macmillan: New York, 1984; p 126.
8. 8.↵
   1. George E. P. Box,
   2. William G. Hunter,
   3. Stuart Hunter J.

   (1978), Statistics for Experimenters, Wiley, NY, 1978, chapter 5.6, 5.5.
9. 9.↵
   1. Ott E. R.

   Process Quality Control; McGraw-Hill: New York, 1975; p 174.
10. 10.↵
    International Organization for Standards. Statistics—Vocabulary and Symbols—Part 2: Applied Statistics, ISO 3534-2, Section 4.6.6, 2006. (https://www.iso.org/obp/ui/#iso:std:iso:3534:-2:ed-2:v1:en, accessed 8/19/14).
11. 11.↵
    1. Hahn G. J.,
    2. Meeker W. Q.

    Statistical Intervals; Wiley: New York, 1991; p 342.