메뉴 건너뛰기




Volumn 64, Issue 4, 2010, Pages 356-363

Evaluation of the ScanRDI® as a rapid alternative to the pharmacopoeial sterility test method: Comparison of the limits of detection

Author keywords

Chemunex ScanRDI ; Most probable number; Rapid sterility test; Sterility testing

Indexed keywords

FLUORESCENT DYE;

EID: 78149331262     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (25)

References (17)
  • 2
    • 0001400448 scopus 로고
    • Application of statistics in bacteriology, I. A means of determining bacterial populations by the dilution method
    • Halvorsen, H. O.; Ziegler, N. R. Application of statistics in bacteriology, I. A means of determining bacterial populations by the dilution method. J. Bacteriol. 1932, 25, 101-121.
    • (1932) J. Bacteriol. , vol.25 , pp. 101-121
    • Halvorsen, H.O.1    Ziegler, N.R.2
  • 3
    • 33646228370 scopus 로고    scopus 로고
    • The expanded application of the most probable number to the quantitative evaluation of extremely low microbial count
    • Sun, X.; Kurosu, S.; Shintani, H. The expanded application of the most probable number to the quantitative evaluation of extremely low microbial count. PDA J. Pharm. Sci. Technol. 2006, 60 (2), 124-134.
    • (2006) PDA J. Pharm. Sci. Technol. , vol.60 , Issue.2 , pp. 124-134
    • Sun, X.1    Kurosu, S.2    Shintani, H.3
  • 4
    • 0028117074 scopus 로고
    • Use of fluorochromes for direct enumeration of total bacteria in environmental samples: Past and present
    • Kepner Jr., R. L.; Pratt. J. R. The use of fluorochromes for the direct enumeration of total bacteria in environmental samples: past and present. Microbiol. Rev. 1994, 58 (4), 603-615. (Pubitemid 124005205)
    • (1994) Microbiology and Molecular Biology Reviews , vol.58 , Issue.4 , pp. 603-615
    • Kepner Jr., R.L.1    Pratt, J.R.2
  • 5
    • 0036794863 scopus 로고    scopus 로고
    • Rapid and sensitive enumeration of viable diluted cells of members of the family Enterobacteriaceae in freshwater and drinking water
    • Baudart, J.; Coallier, J.; Laurent, P.; Prévost, M. Rapid and sensitive enumeration of viable diluted cells of members of the family Enterobacteriaceae in freshwater and drinking water. Appl. Environ. Microbiol. 2002, 68 (10), 5057-5063.
    • (2002) Appl. Environ. Microbiol. , vol.68 , Issue.10 , pp. 5057-5063
    • Baudart, J.1    Coallier, J.2    Laurent, P.3    Prévost, M.4
  • 6
    • 0000555764 scopus 로고    scopus 로고
    • Solid-phase laser scanning cytometry: A new twohour method for the enumeration of microorganisms in pharmaceutical water
    • Jones, D.; Brailsford, M. A.; Drocourt, J.-L. Solid-phase laser scanning cytometry: a new twohour method for the enumeration of microorganisms in pharmaceutical water. Pharmacopoeial Forum 1999, 25 (1), 7626-7645.
    • (1999) Pharmacopoeial Forum , vol.25 , Issue.1 , pp. 7626-7645
    • Jones, D.1    Brailsford, M.A.2    Drocourt, J.-L.3
  • 7
    • 0035216193 scopus 로고    scopus 로고
    • A method for the rapid detection of microbial contaminants in animal cell culture processes
    • Onadipe, A.; Ulvedal; K. A method for the rapid detection of microbial contaminants in animal cell culture processes. PDA J. Pharm. Sci. Technol. 2001, 55 (6), 337-345.
    • (2001) PDA J. Pharm. Sci. Technol. , vol.55 , Issue.6 , pp. 337-345
    • Onadipe, A.1    Ulvedal, K.2
  • 8
    • 0033840542 scopus 로고    scopus 로고
    • Enumeration of total viable microorganisms in antibiotic raw material using ChemScan® solid phase cytometer
    • Ramond, B.; Rolland, X.; Planchez, C.; Cornet, P.; Antoni, C.; Drocourt J.-L. Enumeration of total viable microorganisms in antibiotic raw material using ChemScan® solid phase cytometer. PDA J. Pharm. Sci. Technol. 2000, 54 (4), 320-331.
    • (2000) PDA J. Pharm. Sci. Technol. , vol.54 , Issue.4 , pp. 320-331
    • Ramond, B.1    Rolland, X.2    Planchez, C.3    Cornet, P.4    Antoni, C.5    Drocourt, J.-L.6
  • 9
    • 78149290099 scopus 로고    scopus 로고
    • USP 71 Sterility Tests
    • 31st Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD
    • USP 71 Sterility Tests. In United States Pharmacopeia, 31st Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2008.
    • (2008) United States Pharmacopeia
  • 10
    • 78149341139 scopus 로고    scopus 로고
    • EP 2.6.1 Sterility
    • 6th ed.; European Department for the Quality of Medicines and Healthcare: Strasbourg, France
    • EP 2.6.1 Sterility. In European Pharmacopoeia, 6th ed.; European Department for the Quality of Medicines and Healthcare: Strasbourg, France, 2008.
    • (2008) European Pharmacopoeia
  • 11
    • 78149353897 scopus 로고    scopus 로고
    • Sterility Test
    • 15th ed.; Society of Japanese Pharmacopoeia: Tokyo, Japan
    • Sterility Test. In Japanese Pharmacopoeia, 15th ed.; Society of Japanese Pharmacopoeia: Tokyo, Japan, 2006; p 93.
    • (2006) Japanese Pharmacopoeia , pp. 93
  • 12
    • 44649193166 scopus 로고    scopus 로고
    • Most Probable Number Determination from Serial Dilutions
    • Jackson, G. J., Merker, R. I., Bandler, R.; BAM Project Coordinators
    • Blodgett, R. Most Probable Number Determination from Serial Dilutions. In Bacteriological Analytical Manual; Jackson, G. J., Merker, R. I., Bandler, R.; BAM Project Coordinators. U.S. Food and Drug Administration. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ BacteriologicalAnalyticalManualBAM/default.htm.
    • Bacteriological Analytical Manual
    • Blodgett, R.1
  • 13
    • 78149343686 scopus 로고    scopus 로고
    • USP 1223 Validation of Alternative Microbiological Methods
    • 31st Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD
    • USP 1223 Validation of Alternative Microbiological Methods. In United States Pharmacopeia, 31st Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2008.
    • (2008) United States Pharmacopeia
  • 15
  • 16
    • 78149334051 scopus 로고    scopus 로고
    • EP 2.6.12 Microbial Examination of Nonsterile Products: Total Viable Aerobic Count
    • 6th ed.; European Department for the Quality of Medicines and Healthcare: Strasbourg, France
    • EP 2.6.12 Microbial Examination of Nonsterile Products: Total Viable Aerobic Count. In European Pharmacopoeia, 6th ed.; European Department for the Quality of Medicines and Healthcare: Strasbourg, France, 2008.
    • (2008) European Pharmacopoeia
  • 17
    • 33646266232 scopus 로고    scopus 로고
    • Viability-based rapid microbiological methods for sterility testing and the need for identification of contamination
    • Moldenhauer, J. Viability-based rapid microbiological methods for sterility testing and the need for identification of contamination. PDA J. Pharm. Sci. Technol. 2006, 60 (2), 81-88.
    • (2006) PDA J. Pharm. Sci. Technol. , vol.60 , Issue.2 , pp. 81-88
    • Moldenhauer, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.