Microbial identification strategies in the pharmaceutical industry

PDA Journal of Pharmaceutical Science and Technology

Volumn 60, Issue 2, 2006, Pages 111-123

  Cundell, Anthony M ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DNA 16S; DRUG; DRUG ADDITIVE; EXCIPIENT;

ARTICLE; ASEPSIS; BACTERIAL STRAIN; BACTERIUM CULTURE; BACTERIUM ISOLATE; COLONY FORMING UNIT; DRUG CONTAMINATION; DRUG INDUSTRY; DRUG PURITY; DRUG QUALITY; ENVIRONMENTAL MONITORING; FUNGUS; GAS CHROMATOGRAPHY; GENOTYPE; GOOD MANUFACTURING PRACTICE; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; MASS SPECTROMETRY; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; MICROBIAL CONTAMINATION; MICROBIAL IDENTIFICATION; NONHUMAN; PHENOTYPE; SPECIES IDENTIFICATION; STRAIN IDENTIFICATION; WATER SUPPLY;

DRUG CONTAMINATION; DRUG INDUSTRY; ENVIRONMENTAL MICROBIOLOGY; GENE LIBRARY; GENETICS, MICROBIAL; INDUSTRIAL MICROBIOLOGY; MICROBIOLOGICAL TECHNIQUES; PHARMACOPOEIAS; QUALITY CONTROL; STERILIZATION; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES;

EID: 33646241285     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (16)

1. Sutton, S. V. W.; Cundell, A. M. Microbial identification in the pharmaceutical industry. Pharm. Forum 2004, 30(5), 1884-1894.
2. United States Pharmacopea(USP) Chapters (1231) Water for Pharmaceutical Purposes, USP (1111) Microbiological Attributes of Non-Sterile Pharmaceutical Products, USP (1116) Microbiological Evaluation of Clean Rooms and Other Controlled Environments, (1211) Sterilization and Sterility Assurance of Compendial Articles. The United States Pharmacopeial Convention, Rockville, MD 2005
3. rd edition; J. Wiley and Sons, New York, 1999; p 150.
4. Draft USP Informational Chapter (1111) Microbiological quality of non-sterile pharmaceutical products. Pharm. Forum 2003, 29(5), 1733-1735.
5. USP Chapter (61) Microbial Limit Tests. The United States Pharmacopeial Convention, Rockville, MD 2005
6. USP Informational Chapter (1111) Microbiological Quality of Non-sterile Pharmaceutical Products. The United States Pharmacopeial Convention, Rockville, MD 2005
7. 21 CFR 211.113 Control of microbiological contamination; 21 CFR 211.165 Testing and release for distribution. Code of Federal Regulations Title 21, Volume 4 Revised as of April 1, 2001, U.S. Government Printing Office, Washington, D.C.
8. th edition; Doern, G. V., Section Editor; ASM Press, Washington, D.C. 1995; pp 101-168.
9. O'Hare, C. H. Manual and automated instrumentation for identification of Enterobacteriaceae and other gram-negative bacteria. Clin. Microbiol. Rev. 2005, 18(1), 147-162.
10. Eigner, U.; Schmid, A.; Wild, U.; Bertsch, D.; Fahr, A.-M. Analysis of the comparative work-flow and performance characteristics of the VITEK 2 and Phoenix Systems. J. Clin. Microbiol. 2005, 43(8), 3829-3834.
11. FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Guide. U.S. Department of Health and Human Services, Food and Drug Administration, September 2004
12. Kawai, M.; Matsutera, E.; Kanda, H.; Yamaguchi, N.; Tani, K.; Nasu, M. 16S ribosomal DNA-based analysis of bacterial diversity in purified water used in pharmaceutical manufacturing processes by PCR and denaturing gradient gel electrophoresis. Appl. Environ. Microbiol. 2002, 68(2), 699-704.
13. Pfaller, M. Molecular approaches to diagnosing and managing infectious disease: practicality and costs. Emerg. Infect. Dis. 2001, 7(2), 1-14.
14. Walker, N. J. A technique whose time has come. Science 2002, 296 557-559.
15. Bustin, S. A. Quantification of mRNA using real-time reverse transcription PCR: trends and problems. J. Mol. Endocrinol. 2002, 29, 23-39.
16. MacKay, I. M. Real-time PCR in the microbiology laboratory. Clin. Microbiol. Infect. 2004, 10, 190-212.