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1

Validation of Milliflex^® Quantum for Bioburden Testing of Pharmaceutical Products.

Gordon O, Goverde M, Staerk A, Roesti D. Gordon O, et al. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):206-224. doi: 10.5731/pdajpst.2016.007450. Epub 2017 Feb 14. PDA J Pharm Sci Technol. 2017. PMID: 28196917

2

Fluorescence-based rapid detection of microbiological contaminants in water samples.

Meder H, Baumstummler A, Chollet R, Barrier S, Kukuczka M, Olivieri F, Welterlin E, Beguin V, Ribault S. Meder H, et al. ScientificWorldJournal. 2012;2012:234858. doi: 10.1100/2012/234858. Epub 2012 Apr 30. ScientificWorldJournal. 2012. PMID: 22623887 Free PMC article.

3

Identification of micro-organisms after milliflex rapid detection--a possibility to identify nonsterile findings in the milliflex rapid sterility test.

Gray JC, Morandell D, Gapp G, Le Goff N, Neuhaus G, Staerk A. Gray JC, et al. PDA J Pharm Sci Technol. 2011 Jan-Feb;65(1):42-54. PDA J Pharm Sci Technol. 2011. PMID: 21414939

4

In-process microbial testing: statistical properties of a rapid alternative to compendial enumeration methods.

Friedman EM, Warner M, Shum SC, Adair F. Friedman EM, et al. PDA J Pharm Sci Technol. 2015 Mar-Apr;69(2):264-9. doi: 10.5731/pdajpst.2015.01019. PDA J Pharm Sci Technol. 2015. PMID: 25868992

5

Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products.

Parveen S, Kaur S, David SA, Kenney JL, McCormick WM, Gupta RK. Parveen S, et al. Vaccine. 2011 Oct 19;29(45):8012-23. doi: 10.1016/j.vaccine.2011.08.055. Epub 2011 Aug 24. Vaccine. 2011. PMID: 21871516

6

Validation Study of Rapid Assays of Bioburden, Endotoxins and Other Contamination.

Shintani H. Shintani H. Biocontrol Sci. 2016;21(2):63-72. doi: 10.4265/bio.21.63. Biocontrol Sci. 2016. PMID: 27350424 Free article. Review.

7

A Risk-based Approach to Setting Sterile Filtration Bioburden Limits.

Yang H, Li N, Chang S. Yang H, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):601-9. doi: 10.5731/pdajpst.2013.00942. PDA J Pharm Sci Technol. 2013. PMID: 24265301

8

Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration.

Jones D, Cundell T. Jones D, et al. PDA J Pharm Sci Technol. 2018 Mar-Apr;72(2):199-212. doi: 10.5731/pdajpst.2017.007955. Epub 2017 Dec 14. PDA J Pharm Sci Technol. 2018. PMID: 29242391 Review.

9

Validation of constitutively expressed bioluminescent Pseudomonas aeruginosa as a rapid microbiological quantification tool.

Shah N, Naseby DC. Shah N, et al. Biosens Bioelectron. 2015 Jun 15;68:447-453. doi: 10.1016/j.bios.2015.01.008. Epub 2015 Jan 6. Biosens Bioelectron. 2015. PMID: 25618377

10

Quantitative Microbial Risk Assessment of Pharmaceutical Products.

Eissa ME. Eissa ME. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):245-251. doi: 10.5731/pdajpst.2016.007047. Epub 2016 Dec 14. PDA J Pharm Sci Technol. 2017. PMID: 27974628

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