Review ArticleReview

Molecular Applications to Pharmaceutical Processes and Cleanroom Environments

Luis Jimenez
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 242-253; DOI: https://doi.org/10.5731/pdajpst.2011.00730

References

  1. 1.↵
    1. Denoya C.
    Nucleic acid amplification-based rapid microbiological methods: are these technologies ready for deployment in the pharmaceutical industry? Am. Pharm. Rev. 2009, May/June, 12–21.
    OpenUrl
  2. 2.↵
    1. Easter M. C.
    1. Owen R.
    Techniques for detection of specific organisms and potential for DNA-based technologies. In Rapid Microbiological Methods in the Pharmaceutical Industry, Easter M. C. Ed.; CRC Press: Boca Raton, FL, 2003; pp 161–177.
  3. 3.↵
    1. Friedman R. L.
    Aseptic processing contamination case studies and the pharmaceutical quality system. PDA J. Pharm. Sci. Technol. 2005, 59 (2), 118–126.
    OpenUrlAbstract/FREE Full Text
  4. 4.↵
    1. Cundell A. M.
    Microbial identification strategies in the pharmaceutical industry. PDA J. Pharm. Sci. Technol. 2006, 60 (2), 111–23.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Jimenez L.
    Microbial diversity in pharmaceutical product recalls and environments. PDA J. Pharm. Sci. Technol. 2007, 61 (5), 383–399.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    1. Sutton S.
    Is real-time release through PAT compatible with the ideal of “science-based regulation”? Pharma. Tech. 2007, 31, 97–98.
    OpenUrl
  7. 7.↵
    1. Streefalnd M.,
    2. van de Waterbeemd B.,
    3. Happe H.,
    4. van der Pol L. A.,
    5. Beuvery E. C.,
    6. Tramper J.,
    7. Martens D. E.
    PAT for vaccines: the first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease. Vaccine 2007, 25 (16), 2994–3000.
    OpenUrlCrossRefPubMed
  8. 8.↵
    1. Jimenez L.,
    2. Smalls S.,
    3. Scalici C.,
    4. Bosko Y.,
    5. Ignar R.,
    6. English D.
    Detection of Salmonella spp. contamination in raw materials and cosmetic/pharmaceutical products using the BAX™ system, a PCR-based assay. Journal of Rapid Methods and Automation in Microbiology 1998, 6 (1), 67–76.
    OpenUrl
  9. 9.↵
    1. Kawai M.,
    2. Matsutera E.,
    3. Kanda H.,
    4. Yamaguchi N.,
    5. Tani K.,
    6. 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.
    OpenUrlAbstract/FREE Full Text
  10. 10.↵
    1. Jimenez L.,
    2. Smalls S.,
    3. Grech P.,
    4. Bosko Y.,
    5. Ignar R.,
    6. English D.
    Molecular detection of bacterial indicators in cosmetic/pharmaceuticals and raw materials. Journal of Industrial Microbiology and Biotechnology 1999, 22 (2), 93–95.
    OpenUrl
  11. 11.↵
    1. Jimenez L.,
    2. Smalls S.
    Molecular detection of Burkholderia cepacia in toiletries, cosmetic and pharmaceutical raw materials and finished products. J. AOAC Int. 2000, 83 (4), 963–966.
    OpenUrlPubMed
  12. 12.↵
    1. Mazzola P. G.,
    2. Martins A. M.,
    3. Penna T. C.
    Chemical resistance of the gram-negative bacteria to different sanitizers in a water purification system. BMC Infectious Dis. 2006, 6 (1), 131–136.
    OpenUrl
  13. 13.↵
    1. Zani F.,
    2. Minutello A.,
    3. Maggi L.,
    4. Santi P.,
    5. Mazza P.
    Evaluation of preservative effectiveness in pharmaceutical products: the use of a wild strain of Pseudomonas cepacia. J. Appl. Microbiol. 1997, 83 (3), 322–326.
    OpenUrlPubMed
  14. 14.↵
    1. Jimenez L.,
    2. Bosko S.Y.,
    3. Smalls R.,
    4. Ignar D.
    English. Molecular detection and identification of Aspergillus niger contamination in cosmetic/pharmaceutical raw materials and finished products. Journal of Rapid Methods and Automation in Microbiology 1999, 7, 49–56.
    OpenUrl
  15. 15.↵
    1. Jimenez L.,
    2. Smalls S.,
    3. Ignar R.
    Use of PCR analysis for detecting low levels of bacteria and mold contamination in pharmaceutical samples. J. Microbiol. Methods. 2000, 41 (3), 259–65.
    OpenUrlCrossRefPubMed
  16. 16.↵
    1. Samadi N.,
    2. Alvandi M.,
    3. Reza Fazeli M.,
    4. Azizi E.,
    5. Mehrgan H.,
    6. Naseri M.
    PCR-based detection of low levels of Staphylococcus aureus contamination in pharmaceutical preparations. J. Biol. Sci. 2007, 7 (2), 359–363.
    OpenUrl
  17. 17.↵
    1. Jimenez L.,
    2. Smalls S.,
    3. Scalici C.,
    4. Bosko Y.,
    5. Ignar R.
    PCR detection of Salmonella typhimurium in pharmaceutical raw materials and products contaminated with a mixed bacterial culture using the BAX™ system. PDA J. Pharm. Sci. Technol. 2001, 55 (5), 286–289.
    OpenUrlAbstract/FREE Full Text
  18. 18.↵
    1. Studer E,
    2. Candrian U.
    Identification and characterization by 16S rDNA analysis of viable bacterial colonies isolated from oral medicines based on inactivated or lysed pathogenic bacteria. Biologicals 2003, 31 (1), 39–43.
    OpenUrlPubMed
  19. 19.↵
    1. Jimenez L.
    Simultaneous PCR detection of bacterial and mold DNA sequences in pharmaceutical samples by using a gradient thermocycler. Journal of Rapid Methods and Automation in Microbiology 2002, 9 (4), 263–270.
    OpenUrl
  20. 20.↵
    1. Karanam V. R.,
    2. Reddy H. P.,
    3. Subba Raju B. V.,
    4. Rao J. C.,
    5. Kavikishore P. B.,
    6. Vijayalakshmi M.
    Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods. J. Ind. Microbiol. Biotechnol. 2008, 35 (9), 1007–1018, (2008).
    OpenUrlPubMed
  21. 21.↵
    1. Farajnia S.,
    2. Hassan M.,
    3. Hallaj Nezhadi S.,
    4. Mohammednejad L.,
    5. Milani M.,
    6. Lotfipour F.
    Determination of indicator bacteria in pharmaceutical samples by multiplex PCR. Journal of Rapid Methods in Automation in Microbiology 2009, 17 (3), 328–338.
    OpenUrl
  22. 22.↵
    1. Kwon H. S.,
    2. Yang E. H.,
    3. Lee S. H.,
    4. Yeon S. W.,
    5. Kang B. H.,
    6. Kim T. Y.
    Rapid identification of potentially probiotic Bifidobacterium species by multiplex PCR using species-specific primers based on the region extending from 16S rRNA through 23S rRNA. FEMS Microbiol Lett. 2005, 250 (1), 55–62.
    OpenUrlAbstract/FREE Full Text
  23. 23.↵
    1. Jimenez L.,
    2. Ignar R.,
    3. D'Aiello R.,
    4. Grech P.
    Use of PCR analysis for sterility testing in pharmaceutical environments. Journal of Rapid Methods and Automation in Microbiology 2000, 8 (1), 11–20.
    OpenUrl
  24. 24.↵
    1. Versalovic J. M.,
    2. Schneider M.,
    3. De Brujin F. J.,
    4. Lupski J. R.
    Genomic fingerprinting of bacteria using repetitive sequence-based polymerase chain reaction. Methods Mol. Cell. Biol. 1994, 5 (1), 25–40.
    OpenUrl
  25. 25.↵
    1. De Clerck E.,
    2. Vanhoutte T.,
    3. Hebb T.,
    4. Geerinck J.,
    5. Devos J.,
    6. De Vos P.
    Isolation, characterization, and identification of bacterial contaminants in semifinal gelatin extracts. Appl. Environ. Microbiol. 2004, 70 (6), 3664–72.
    OpenUrlAbstract/FREE Full Text
  26. 26.↵
    1. Merker P.,
    2. Grohman L.,
    3. Petersen R.,
    4. Ladewig J.,
    5. Gerbling K. P.,
    6. Lauter F. R.
    Alternative microbial testing: a novel DNA-based detection system for specified microorganisms in pharmaceutical preparations. PDA J. Pharm. Sci. Technol. 2000, 54 (6), 470–477.
    OpenUrlAbstract/FREE Full Text
  27. 27.↵
    1. Skof A.,
    2. Poljak M.,
    3. Krbavcic
    . Real-time polymerase chain reaction for detection of Staphylococcus aureus and Pseudomonas aeruginosa in pharmaceutical products for topical use. Journal of Rapid Methods and Automation in Microbiology 2004, 12 (3), 169–183.
    OpenUrl
  28. 28.↵
    1. Walzer A.,
    2. Tiemann F.,
    3. Knaeblein J.,
    4. Gerbling K. P.,
    5. Mueller R. H.,
    6. Bunte T.
    Rapid diagnostic method for quantitative testing of <100 microbes in water. PDA J. Pharm. Sci. Technol. 2007, 61 (5), 411–420.
    OpenUrlAbstract/FREE Full Text
  29. 29.↵
    1. Brown D. B.,
    2. Newman J. A.,
    3. Gutenkunst J. M.,
    4. McManus J. B.,
    5. Letham D. L. D.,
    6. Weber T. J.,
    7. Mamalat G.,
    8. Bruk N.,
    9. Montgomery L. K.,
    10. Thompson S.,
    11. Hantman M. J.
    Assay validation for rapid detection of mycoplasma contamination. BioProcess International 2009, 7 (4), 30–40.
    OpenUrl
  30. 30.↵
    1. Kulakov L. A.,
    2. McAlister M. B.,
    3. Ogden K. L.,
    4. Larkin M. L.,
    5. O'Hanlon J. F.
    Analysis of bacteria contaminating ultrapure water in industrial systems. Appl. Environ. Microbiol. 2002, 68 (4), 1548–1555.
    OpenUrlAbstract/FREE Full Text
  31. 31.↵
    1. Kawai M.,
    2. Yamagishi J.,
    3. Yamaguchi N.,
    4. Tani K.,
    5. Nasu M.
    Bacterial population dynamics and community structure in a pharmaceutical manufacturing water supply system determined by real-time PCR and PCR-denaturing gradient gel electrophoresis. J. Appl. Microbiol. 2004, 97 (6), 1123–1131.
    OpenUrlCrossRefPubMed
  32. 32.↵
    1. Nagarkar P.,
    2. Ravetkar S. D.,
    3. Watve M. G.
    Oligophilic bacteria as tools to monitor aseptic pharmaceutical production units. Appl. Environ. Microbiol. 2001, 67 (3), 1371–1374.
    OpenUrlAbstract/FREE Full Text
  33. 33.↵
    1. Venkateswaran K.,
    2. Hattori N.,
    3. La Duc M. T.,
    4. Kern R.
    ATP as a biomarker of viable microorganisms in clean room facilities. J. Microbiol. Methods 2003, 52 (3), 367–377.
    OpenUrlCrossRefPubMedWeb of Science
  34. 34.↵
    1. La Duc M. T.,
    2. Dekas A.,
    3. Osman S.,
    4. Moissl C.,
    5. Newcombe D.,
    6. Venkateswaran K.
    Isolation and characterization of bacteria capable of tolerating the extreme conditions of clean room environments. Appl. Environ. Microbiol. 2007, 73 (8), 2600–2611.
    OpenUrlAbstract/FREE Full Text
  35. 35.↵
    1. La Duc M. T.,
    2. Osman S.,
    3. Vaishampayan P.,
    4. Piceno I.,
    5. Andersen G.,
    6. Venkateswaran K.
    Comprehensive census of bacteria in clean rooms by using DNA microarray and cloning methods. Appl. Environ. Microbiol. 2009, 75 (20), 6559–6567.
    OpenUrlAbstract/FREE Full Text
  36. 36.↵
    1. Probst A.,
    2. Vaishampayan P.,
    3. Osman S.,
    4. Moissl C.,
    5. Andersen G.,
    6. Venkateswaran K.
    Diversity of anaerobic microbes in spacecraft assembly clean rooms. Appl. Environ. Microbiol. 2010, 76 (9), 2837–2845.
    OpenUrlAbstract/FREE Full Text
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Molecular Applications to Pharmaceutical Processes and Cleanroom Environments
Luis Jimenez
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 242-253; DOI: 10.5731/pdajpst.2011.00730
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