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Review ArticleReview

Burkholderia cepacia: This Decision Is Overdue

Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, Richard L. Friedman and David Hussong
PDA Journal of Pharmaceutical Science and Technology September 2011, 65 (5) 535-543; DOI: https://doi.org/10.5731/pdajpst.2011.00793
Lynn Torbeck
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Diane Raccasi
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Dennis E. Guilfoyle
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Richard L. Friedman
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  • For correspondence: Rick.Friedman@fda.hhs.gov
David Hussong
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References

  1. 1.↵
    1. Torbeck L.
    Recall Root Cause Analysis. FDA/PDA Joint Regulatory Conference, Washington, DC, September 9, 2008.
  2. 2.
    1. Torbeck L.,
    2. Friedman R.,
    3. Smedley M.
    An overview of CDER’s Recall Root Cause Assessment Project. Pharm. Technol. 2009, 33 (8), 42–45.
    OpenUrl
  3. 3.↵
    1. Friedman R.,
    2. Smedley M.,
    3. Torbeck L.,
    4. Santiago I.
    An initial report of CDER’s Recall Root Cause Assessment Project. Pharm. Technol. 2011, 35 (1), 66–69.
    OpenUrl
  4. 4.↵
    1. Holmes A.,
    2. Govan J.,
    3. Goldstein R.
    Agricultural use of Burkholderia (Pseudomonas) cepacia A threat to human health? Emerg. Infect. Dis. 1998, 4 (2), 221–227.
    OpenUrlPubMedWeb of Science
  5. 5.↵
    1. Vandamme P.
    Burkholderia cepacia: Pandora’s Box redefined. BCCM News 2001, 9, 2–3.
    OpenUrl
  6. 6.↵
    1. Sousa S. A.,
    2. Ramos C. G.,
    3. Leitão J. H.
    Burkholderia cepacia complex: Emerging multihost pathogens equipped with a wide range of virulence factors and determinants. Int. J. Microbiol. 2011, doi:10.1155/2011/607575.
  7. 7.↵
    1. Mandell L.,
    2. Bennett E.,
    3. Dolin R.
    Principles and practice of infectious diseases. Churchill Livingstone, 2000.
  8. 8.↵
    1. Miller S. C. M.,
    2. LiPuma J. J.,
    3. Parke J.
    Culture-based and non-growth-dependent detection of the Burkholderia cepacia complex in soil environments. Appl. Environ. Microbiol. 2002, 68 (8), 3750–3758.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    1. Jimenez L.
    Microbial Contamination Control in the Pharmaceutical Industry; Marcel Dekker: New York, 2004.
  10. 10.↵
    1. Vial L.,
    2. Chapalain A.,
    3. Groleau M. C.,
    4. Deziel E.
    Minireview—the various lifestyles of the Burkholderia cepacia complex species: a tribute to adaptation. Environmental Microbiology 2011, 13 (1), 1–12.
    OpenUrlCrossRefPubMed
  11. 11.↵
    1. Murray P,
    2. Baron E.,
    3. Pfaller M.,
    4. Tenover F.,
    5. Yolken R.
    1. Gilligan P.,
    2. Whittier S.
    Burkholderia, Stenotrophomonas, Ralstonia, Brevundimonas, Comamonas, and Adidoboras; Murray P, Baron E., Pfaller M., Tenover F., Yolken R. Manual of Clinical Microbiology, American Society for Microbiology, Washington, D.C., 1999, p 526.
  12. 12.↵
    1. Carson L.,
    2. Favero M. S.,
    3. Bond W. W.,
    4. Peterson N. J.
    Morphological, biochemical, and growth characteristics of Pseudomonas cepacia from distilled water. Appl. Microbiol. 1973, 25 (3), 476–483.
    OpenUrlPubMedWeb of Science
  13. 13.↵
    1. Donlan R. M.
    Biofilms and device-associated infections. Emerg. Infect. Dis. 2001, 7 (2), 277–281.
    OpenUrlCrossRefPubMedWeb of Science
  14. 14.↵
    1. Anwar H.,
    2. Dasgupta M. K.,
    3. Costerton J. W.
    Testing the susceptibility of bacteria in biofilms to antibacterial agents. Antimicrob. Agents Chemother. 1990, 34 (11), 2043–2046.
    OpenUrlFREE Full Text
  15. 15.↵
    Department of Health and Human Services, Office of Compliance, Bureau of Drugs. “Letter to the pharmaceutical industry, RE: Validation and control of deionized water systems.” August 1981.
  16. 16.↵
    FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories. 1993.
  17. 17.↵
    1. Luigi C.
    Burkholderia cepacia complex species: health hazards and biotechnological potential. Trends Microbiol. 2006, 14 (6), 277–286.
    OpenUrlCrossRefPubMed
  18. 18.↵
    World Health Organization. Antimicrobial resistance, Fact sheet, No. 194. (Online). Updated January 2002. http://www.who.int/mediacentre/factsheets/fs194/en/index.html.
  19. 19.↵
    1. Moore J.,
    2. Elborn J.
    Burkholderia cepacia and cystic fibrosis. http://www.cysticfirbrosismedicine.com, 2003.
  20. 20.↵
    1. De Soyza A.,
    2. McDowell A.,
    3. Archer L.,
    4. Dark J. H.,
    5. Elborn S. J.,
    6. Mahenthiralingam E.,
    7. Gould K.,
    8. Corris P. A.
    Burkholderia cepacia complex genomovars and pulmonary transplantation outcomes in patients with cystic fibrosis. Lancet 2001, 358 (9295), 1780–1781.
    OpenUrlCrossRefPubMedWeb of Science
  21. 21.↵
    1. Chaparro C.,
    2. Maurer J.,
    3. Gutierrez C.,
    4. Krajden M.,
    5. Chan C.,
    6. Winton T.,
    7. Keshavjee S.,
    8. Scavuzzo M.,
    9. Tullis E.,
    10. Hutcheon M.,
    11. Kesten S.
    Infection with Burkholderia cepacia in cystic fibrosis: outcome following lung transplantation. Am. J. Respir. Crit. Care Med. 2001, 163 (1), 43–48.
    OpenUrlPubMedWeb of Science
  22. 22.↵
    1. Ledson M.
    Outcome of Burkholderia cepacia colonization in an adult cystic fibrosis centre. Thorax 2002, 57 (2) 142–145.
    OpenUrlAbstract/FREE Full Text
  23. 23.↵
    1. Kaper J.,
    2. Saylor G.,
    3. Baldini M.,
    4. Colwell R.
    Ambient-temperature primary nonselective enrichment for isolation for Salmonella spp. from an estuarine environment. Appl. Environ. Microbiol. 1977, 33 (4) 829–835.
    OpenUrlAbstract/FREE Full Text
  24. 24.↵
    1. Henry D.,
    2. Campbell M.,
    3. McGimpsey C.,
    4. Clarke A.,
    5. Louden L.,
    6. Burns J. L.,
    7. Roe M. H.,
    8. Vandamme P.,
    9. Speert D.
    Comparison of isolation media for recovery of Burkholderia cepacia complex from respiratory secretions of patients with cystic fibrosis. J. Clin. Microbiol. 1999, 37 (4) 1004–1007.
    OpenUrlAbstract/FREE Full Text
  25. 25.↵
    United States Pharmacopeia. USP 〈61〉 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. United States Pharmacopeial Convention: Rockville, MD, 2008.
  26. 26.↵
    United States Pharmacopeia. USP 〈62〉 Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms. United States Pharmacopeial Convention: Rockville, MD, 2008.
  27. 27.↵
    United States Pharmacopeia. USP 〈63〉 Mycoplasma. United States Pharmacopeial Convention: Rockville, MD, 2008.
  28. 28.↵
    United States Pharmacopeia. USP 〈1111〉 Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. United States Pharmacopeial Convention: Rockville, MD, 2008.
  29. 29.↵
    1. Halls N.
    Burkholderia (Pseudomonas) cepacia—a brief profile for the pharmaceutical microbiologist. Eur. J. Parent. Pharm. Sci. 2006, 11 (2) 53.
    OpenUrl
  30. 30.
    FDA Investigations Operations Manual. 7.1 Recalls, 2008.
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PDA Journal of Pharmaceutical Science and Technology: 65 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 5
September/October 2011
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Burkholderia cepacia: This Decision Is Overdue
Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, Richard L. Friedman, David Hussong
PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 535-543; DOI: 10.5731/pdajpst.2011.00793

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Burkholderia cepacia: This Decision Is Overdue
Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, Richard L. Friedman, David Hussong
PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 535-543; DOI: 10.5731/pdajpst.2011.00793
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  • Design, Development, and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the Burkholderia cepacia Complex in Water with an Equivalence to ISO/TS 12869:2019
  • Do Plant Isolates Have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is It a Matter of Science versus Compliance?
  • Mapping the Efficacy and Mode of Action of Ethylzingerone [4-(3-Ethoxy-4-Hydroxyphenyl) Butan-2-One] as an Active Agent against Burkholderia Bacteria
  • Burkholderia cepacia Complex Bacteria: a Feared Contamination Risk in Water-Based Pharmaceutical Products
  • Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
  • Intrinsic Resistance of Burkholderia cepacia Complex to Benzalkonium Chloride
  • Draft Genome Sequences of Burkholderia contaminans FFI-28, a Strain Isolated from a Contaminated Pharmaceutical Solution
  • Direct Detection of Burkholderia cepacia in Susceptible Pharmaceutical Products Using Semi-Nested PCR
  • Draft Genome Sequences of Burkholderia contaminans, a Burkholderia cepacia Complex Species That Is Increasingly Recovered from Cystic Fibrosis Patients
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More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
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