Comparison of Different Fungal Agar for the Environmental Monitoring of Pharmaceutical-Grade Cleanrooms

References

1. 1.↵
   1. Vijayakumar R.,
   2. Sandle T.,
   3. Manoharan C.

   A review of fungal contamination in pharmaceutical products and phenotypic identification of contaminants by conventional methods. Eur. J. Parenter. Pharm. Sci. 2012, 17 (1), 4–19.

   OpenUrl
2. 2.↵
   1. Cox B.

   A lesson on outsourcing: the NECC fungal meningitis outbreak. The Gold Sheet 2012, 46 (11), 1–6.

   OpenUrl
3. 3.↵
   1. Kainer M. A.,
   2. Reagan D. R.,
   3. Nguyen D. B.

   Fungal infections associated with contaminated methylprednisolone in Tennessee. N. Engl. J. Med. 2012, 367 (23), 2194–2203.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Eglovitch J. S.

   Lack of microbiological controls have grave consequences for compounders. The Gold Sheet 2012, 46 (11), 16–18.

   OpenUrl
5. 5.↵
   The Rules Governing Medicinal Products in the European Union; Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use; Annex 1. Manufacture of Sterile Medicinal Products; EU EudraLex: Brussels, Belgium, 2009.
6. 6.↵
   ISO 14644-1 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness; International Standards Organisation, Geneva, Switzerland, 1999.
7. 7.↵
   1. Sandle T.

   A review of cleanroom microflora: types, trends and patterns. PDA J. Pharm. Sci. Technol. 2011, 65 (4), 392–403.

   OpenUrlAbstract/FREE Full Text
8. 8.↵
   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
9. 9.↵
   1. Vijayakumar R.,
   2. Kannan V. V.,
   3. Sandle T.,
   4. Manoharan C.

   In vitro antifungal efficacy of biguanides and quaternary ammonium compounds against cleanroom fungal isolate., PDA J. Pharm. Sci. Technol. 2012, 66 (3), 236–242.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Moldenhauer J.

    1. Sandle T.

    Environmental Monitoring: A Practical Approach. In Moldenhauer J. Environmental Monitoring: A Comprehensive Handbook; PDA/DHI: River Grove, IL, 2012; Vol. 6, pp 29–54.

    OpenUrl
11. 11.↵
    1. Balows A.,
    2. Triiper H. G.,
    3. Dworkin M.,
    4. Harder W.,
    5. Schleifer K. H.

    1. Bock E.,
    2. Koops H. P.

    The Genus Nitrobacter and Related Genera. In The Prokaryotes, 2nd ed.; Balows A., Triiper H. G., Dworkin M., Harder W., Schleifer K. H., Eds.; Springer-Verlag: New York, 1992, Vol. 111, pp 2302–2323.

    OpenUrl
12. 12.↵
    1. Cobo F.,
    2. Concha Á.

    Environmental microbial contamination in a stem cell bank. Lett. Appl. Microbiol. 2007, 44 (4), 379–386.

    OpenUrlPubMed
13. 13.↵
    1. Wu G. F.,
    2. Liu X. H.

    Characterization of predominant bacteria isolates from cleanrooms in a pharmaceutical production unit. J. Zhejiang Univ. Sci. B 2007, 8 (9), 666–672.

    OpenUrlCrossRefPubMed
14. 14.↵
    1. Sandle T.,
    2. Boschi F.

    1. Boschi F.

    Issues That Can Affect the Accuracy of Environmental Monitoring Data. In Sandle T., Boschi F. Environmental Monitoring: A Handbook; Institute of Validation Technology: Duluth, MN, 2006; pp 30–39.
15. 15.↵
    1. Whitman W. B.,
    2. Coleman D. C.,
    3. Wiebe W. J.

    Prokaryotes: the unseen majority. Proc. Natl. Acad. Sci. USA 1998, 95 (12), 6578–6583.

    OpenUrlAbstract/FREE Full Text
16. 16.↵
    1. Sandle T.

    1. Sandle T.

    Application of Disinfectants and Detergents in the Pharmaceutical Sector. In Sandle T. The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms; Grosvenor House Publishing: Surrey, U.K., 2012; pp 168–197.
17. 17.↵
    1. Sandle T.,
    2. Skinner K.

    Study of psychrophilic and psychrotolerant microorganisms isolated in cold rooms used for pharmaceutical processing, Journal of Applied Microbiology 2013, in press.
18. 18.↵
    FDA Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, Food and Drug Administration: Rockville, MD, 2004.
19. 19.↵
    Chapter G4. Microbial Evaluation of Processing Areas for Sterile Pharmaceutical Products. Japanese Pharmacopoeia, 16th ed., 2011; p 2213.
20. 20.↵
    1. Tetzlaff R. F.

    Investigational trends: cleanroom environmental monitoring. J. Parenter. Sci. Technol. 1992, 46 (6), 206 –14.

    OpenUrlPubMed
21. 21.↵
    1. Clontz L.

    Environmental monitoring. Pharmaceutical Microbiology Forum Newsletter 2004, 11 (1), 2–4.

    OpenUrl
22. 22.↵
    1. Marshall V.,
    2. Poulson-Cook S.,
    3. Moldenhauer J.

    Comparative mold and yeast recovery analysis (the effect of differing incubation temperature ranges and growth media). PDA J. Pharm. Sci. Technol. 1998, 52 (4), 165–169.

    OpenUrlAbstract/FREE Full Text
23. 23.↵
    1. Moissl C.,
    2. Osma S.,
    3. La Duc M. T.,
    4. Dekas A.,
    5. Brodie E.,
    6. DeSantis T.,
    7. Venkateswaran K.

    Molecular bacterial community analysis of cleanrooms where spacecraft are assembled. FEMS Micrbiol. Ecol. 2007, 61 (3), 509–521.

    OpenUrl
24. 24.↵
    1. Owers K. L.,
    2. James E.,
    3. Bannister G. C.

    Source of bacterial shedding in laminar flow theatres. J. Hosp. Infect. 2004, 58 (3), 230–232.

    OpenUrlCrossRefPubMed
25. 25.↵
    1. La Duc M. T.,
    2. Osman S.,
    3. Vaishampayan P.,
    4. Piceno Y.,
    5. Andersen G.,
    6. Spry J. A.,
    7. Venkateswaran K.

    Comprehensive census of bacteria in cleanrooms by using DNA microarray and cloning methods. Appl. Environ. Microbiol. 2009, 75 (20), 6559–6567.

    OpenUrlAbstract/FREE Full Text
26. 26.↵
    1. Wilson S. C.,
    2. Palmatierb R. N.,
    3. Andriychuka L. A.,
    4. Martina J. M.,
    5. Jumperc C. A.,
    6. Holdera H. W.,
    7. Strausa D. C.

    Mold contamination and air handling units. Journal of Occupational and Environmental Hygiene 2007, 4 (7), 483–491.

    OpenUrlCrossRefPubMed
27. 27.↵
    1. Cundell A. M.

    Microbial identification strategies in the pharmaceutical industry. PDA J. Pharm. Sci. Technol. 2006, 60 (2), 111–123.

    OpenUrlAbstract/FREE Full Text
28. 28.↵
    1. Sutton S. V. W,
    2. Cundell A. M.

    Microbial identification in the pharmaceutical industry. Pharm. Forum. 2004, 30 (5), 1884–1894.

    OpenUrl
29. 29.↵
    1. Bridson E. Y.

    Oxoid: The Manual, 9th ed.; Oxoid: Basingstoke, U.K., 2006.
30. 30.↵
    1. Wu P. C.,
    2. Su H. J.,
    3. Ho H. M.

    A comparison of sampling media for environmental viable fungi collected in a hospital environment, Environ. Res. 2000, 82 (3), 253–257.

    OpenUrlPubMed
31. 31.↵
    1. Burge H.

    Bioaerosol—prevalence and health effects in the indoor environment. Journal of Allergy and Clinical Immunology 1990, 86 (5), 687–701.

    OpenUrlCrossRefPubMedWeb of Science
32. 32.↵
    1. Tormo-Molina R,
    2. Gonzalo-Garijo MA,
    3. Fernández-Rodríguez S,
    4. Silva-Palacios I.

    Monitoring the occurrence of indoor fungi in a hospital, Rev Iberoam Micol. 2012, 29(4), 227–234.

    OpenUrlPubMed
33. 33.↵
    1. Segvić Klarić M,
    2. Pepeljnjak S.

    A year-round aeromycological study in Zagreb area, Croatia, Ann Agric Environ Med. 2006, 13(1), 55–64.

    OpenUrlPubMed
34. 34.↵
    1. Beuchat L.R.,
    2. Frandberg E.,
    3. Deak T.,
    4. Alzamora S.M.,
    5. Chen J.,
    6. Guerrero A.S.,
    7. López-Malo A.,
    8. Ohlsson I.,
    9. Olsen M.,
    10. Peinado J.M.,
    11. Schnurer J.,
    12. de Siloniz M.I.,
    13. Tornai-Lehoczki J.

    Performance of mycological media in enumerating desiccated food spoilage yeasts: an interlaboratory study, Int J Food Microbiol. 2001, 70(1-2), 89–96.

    OpenUrlPubMed
35. 35.↵
    1. Corry J.E.L.,
    2. Curtis G.D. W.,
    3. Baird R.M.

    1. Beuchat LR.

    Media for detecting and enumerating yeasts and moulds. Chapter 14 in: Corry J.E.L., Curtis G.D. W., Baird R.M. (Eds.) Culture Media for Food Microbiology. 1995, V34, Elsvier Science BV. Amsterdam, The Netherlands.
36. 36.↵
    1. Montville T. J.,
    2. Matthews K. R.

    Food Microbiology: An Introduction, 2nd ed.; ASM Press: Herndon, VA, 2008.
37. 37.↵
    1. Ottria G.,
    2. Dallera M.,
    3. Aresu O.,
    4. Manniello M. A.,
    5. Parodi B.,
    6. Spagnolo A. M.,
    7. Cristina M. L.

    Environmental monitoring program in the cell therapy facility of a research centre: preliminary investigation. J. Prev. Med. Hyg. 2010, 51 (4), 133–138.

    OpenUrlPubMed
38. 38.↵
    1. Moissl-Eichinger C.,
    2. Rettberg P.,
    3. Pukall R.

    The first collection of spacecraft-associated microorganisms: a public source for extremotolerant microorganisms from spacecraft assembly cleanrooms, Astrobiology 2012, 12 (11), 1024–1034.

    OpenUrlPubMed
39. 39.↵
    1. Whyte W.

    In support of settle plates. PDA J. Pharm. Sci. Technol. 1996, 50 (4), 201–204.

    OpenUrlAbstract/FREE Full Text
40. 40.↵
    1. Sabouraud R.

    Recherche des Milieux de Culture Propres a la Différenciation des Espèces Trichophytiques a Grosse Spore. Les Trichophyties Humaines; Masson et Cie: Paris, France, 1896; pp 49–55.
41. 41.↵
    1. Kim K. Y.,
    2. Kim Y. S.,
    3. Kim D.

    Distribution characteristics of airborne bacteria and fungi in the general hospitals of Korea. Ind. Health 2010, 48 (2), 236–243.

    OpenUrlCrossRefPubMed
42. 42.↵
    1. Hibbet D. S.,
    2. Ohman A.,
    3. Glotzer D.,
    4. Huhn M.,
    5. Kirk P.,
    6. Nilsson R. H.

    Progress in molecular and morphological taxon discovery in Fungi and options for formal classification of environmental sequences. Fungal Biology Reviews 2011, 25 (1), 38–47.

    OpenUrl
43. 43.↵
    1. Nilsson R. H.,
    2. Abarenkov K.,
    3. Veldre V.,
    4. Nylinder S.,
    5. De Wit P.,
    6. Brosche S.,
    7. Alfredsson J. F.,
    8. Ryberg M.,
    9. Kristiansson E.

    An open source chimera checker for the fungal ITS region. Molecular Ecology Resources 2010, 10 (6), 1076–1081.

    OpenUrlCrossRefPubMedWeb of Science