Evaluation of the BioVigilant® IMD-A™, A Novel Optical Spectroscopy Technology for the Continuous and Real-time Environmental Monitoring of Viable and Nonviable Particles. Part I. Review of the Technology and Comparative Studies with Conventional Methods

References

1. 1.↵
   United States Pharmacopeia, USP 31-NF26. General Information Chapter 〈1116〉 Microbiological Evaluation of Cleanrooms and Other Controlled Environments. U.S. Pharmacopeial Convention: Rockville, MD, 2009.
2. 2.↵
   Food and Drug Administration (FDA). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice; U.S. Department of Health and Human Services, FDA: Rockville, 2004. Available at http://www.fda.gov/cber/gdlns/steraseptic.pdf.
3. 3.↵
   European Commission. EU Guidelines to Good Manufacturing Practice, Annex 1. Manufacture of Sterile Medicinal Products; EudraLex, European Union: Brussels, Belgium, 2008. Available at http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/2008_02_12_gmp_annex1.pdf.
4. 4.↵
   1. Moldenhauer J.

   Environmental Monitoring, A Comprehensive Handbook; Moldenhauer J. Ed.; DHI Publishing: River Grove, IL and Parenteral Drug Association (PDA): Bethesda, MD, 2007; Vol. 1 and 2.
5. 5.↵
   1. Prince R.

   1. Miller M. J.

   Rapid Microbiological Methods. In Microbiology in Pharmaceutical Manufacturing,; Prince R. Ed.; DHI Publishing: River Grove, IL and PDA: Bethesda, MD, 2008; Vol. 2, pp 171– 221.

   OpenUrl
6. 6.
   1. Roszak D. B.,
   2. Colwell R. R.

   Survival strategies of bacteria in the natural environment. Microbiol. Rev. 1987, 51, 365– 379.

   OpenUrlFREE Full Text
7. 7.
   1. Colwell R. R.,
   2. Brayton P. R.,
   3. Grimes D. J.,
   4. Roszak D. B.,
   5. Huq S. A.,
   6. Palmer L. M.

   Viable but non-culturable Vibrio cholerae and related pathogens in the environment: implications for release of genetically engineered microorganisms. Biotechnol. 1985, 3, 817– 820.

   OpenUrl
8. 8.
   1. Colwell R. R.,
   2. Brayton P.,
   3. Herrington D.,
   4. Tall B.,
   5. Huq A.,
   6. Levine M. M.

   Viable but non-culturable Vibrio cholerae 01 revert to a cultivable state in the human intestine. World J. Microbiol. Biotechnol. 1996, 12, 28– 31.

   OpenUrlCrossRef
9. 9.
   1. Nagarkar P. P.,
   2. Ravetkar S. D.,
   3. Watve M. G.

   Oligophilic bacteria as tools to monitor aseptic pharmaceutical production units. App. Env. Microbiol. 2001, 67, 1371– 1374.

   OpenUrlAbstract/FREE Full Text
10. 10.
    1. Williams R. H.,
    2. Ward E.,
    3. McCartney H. A.

    Methods for integrated air sampling and DNA analysis for detection of airborne fungal spores. App. Env. Microbiol. 2001, 67, 2453– 2459.

    OpenUrlAbstract/FREE Full Text
11. 11.
    1. Radosevich J. L.,
    2. Wilson W. J.,
    3. Shinn J. H.,
    4. DeSantis T. Z.,
    5. Andersen G. L.

    Development of a high-volume aerosol collection system for the identification of air-borne micro-organisms. Soc. App. Microbiol. 2002, 34, 162– 167.

    OpenUrl
12. 12.
    1. Amann R. I.,
    2. Ludwig W.,
    3. Schleifer K. H.

    Phylogenetic identification and in situ detection of individual microbial cells without cultivation. Microbiol. Rev. 1995, 59, 143– 169.

    OpenUrlAbstract/FREE Full Text
13. 13.
    1. Hugenholtz P.,
    2. Goebel B. M.,
    3. Pace N. R.

    Impact of culture-independent studies on the emerging phylogenetic view of bacterial diversity. J. Bacteriol. 1998, 180, 4765– 4774.

    OpenUrlFREE Full Text
14. 14.
    1. Hussong D.,
    2. Colwell R. R.,
    3. O'Brien M.,
    4. Weiss E.,
    5. Pearson A. D.,
    6. Weiner R. M.,
    7. Burge W. D.

    Viable Legionella pneumophila not detectable by culture on agar media. Biotechnol. 1987, 5, 947– 950.

    OpenUrl
15. 15.↵
    1. Alvarez A. J.,
    2. Buttner M. P.,
    3. Stetzenbach L. D.

    PCR for bioaerosol monitoring: sensitivity and environmental interference. App. Env. Microbiol. 1995, 61, 3639– 3644.

    OpenUrlAbstract/FREE Full Text
16. 16.
    1. Bhupathiraju V. K.,
    2. Hernandez M.,
    3. Krauter P.,
    4. Alvarez-Cohen L.

    A new direct microscopy-based method for evaluating in-situ bioremediation. J. Hazard. Mat. 1999, 67, 299– 312.

    OpenUrlPubMed
17. 17.↵
    1. Macher J. M.,
    2. First M. W.

    Reuter centrifugal air sampler: measurement of effective airflow rate and collection efficiency. App. Env. Microbiol. 1983, 45, 1960– 1962.

    OpenUrlAbstract/FREE Full Text
18. 18.↵
    1. Jensen P. A.,
    2. Todd W. F.,
    3. Davis G. N.,
    4. Scarpino P. V.

    Evaluation of eight bioaerosol samplers challenged with aerosols of free bacteria. Am. Ind. Hyg. Assoc. J. 1992, 53, 660– 667.

    OpenUrlPubMed
19. 19.↵
    1. Yao M.,
    2. Mainelis G.

    Investigation of cut-off sizes and collection efficiencies of portable microbial samplers. Aerosol Sci. Technol. 2006, 40, 595– 606.

    OpenUrl
20. 20.↵
    1. Yao M.,
    2. Mainelis G.

    Use of portable microbial samplers for estimating inhalation exposure to viable biological agents. J. Exposure Sci. Environ. Epidemiol. 2007, 17, 31– 38.

    OpenUrl
21. 21.↵
    1. Miller M. J.

    Rapid microbiological methods and FDA's initiatives for process analytical technology and pharmaceutical cGMPs for the 21^st century: a risk-based approach. Am. Pharm. Rev. 2005, 8, 104– 107.

    OpenUrl
22. 22.↵
    1. Miller M. J.

    Rapid microbiological methods for a new generation. Pharm. Manufac. 2006, 5, 14– 23.

    OpenUrl
23. 23.↵
    1. Miller M. J.

    1. Miller M. J.

    The Impact of Process Analytical Technology (PAT), cGMPs for the 21st Century and Other Regulatory and Compendial Initiatives on the Implementation of Rapid Microbiological Methods. In Encyclopedia of Rapid Microbiological Methods—Volume 1; Miller M. J. Ed.; DHI Publishing: River Grove, IL and PDA: Bethesda: PDA, 2005; pp 195– 215.
24. 24.↵
    1. Miller M. J.

    1. Jiang J. P.

    Instantaneous Microbial Detection Using Optical Spectroscopy. In Encyclopedia of Rapid Microbiological Methods—Volume 3; Miller M. J. Ed. DHI Publishing: River Grove, IL and PDA: Bethesda, MD, 2005; pp 121– 141.
25. 25.↵
    1. Bhupathiraju V. K.,
    2. Varnau B.,
    3. Nelson J. R.,
    4. Jiang J. P.,
    5. Bolotin C.

    Evaluation of an instantaneous microbial detection system in controlled and cleanroom environments. BioPharm Int. 2007, 20, 35– 46.

    OpenUrl
26. 26.↵
    1. Zhang Y.

    Indoor Air Quality Engineering. CRC Press: Boca Raton, FL, 2004.
27. 27.↵
    1. Juozaitis A.,
    2. Willeke K.,
    3. Grinshpun S. A.,
    4. Donnelly J.

    Impaction onto a glass slide or agar versus impingement into a liquid for the collection and recovery of airborne microorganisms. App. Env. Microbiol. 1994, 60, 861– 870.

    OpenUrlAbstract/FREE Full Text
28. 28.↵
    1. Jones H. G.

    Plants and Microclimate. A Quantitative Approach to Environmental Plant Physiology; Cambridge University Press: Cambridge, UK, 1992.
29. 29.↵
    1. Buttner M. P.,
    2. Stetzenbach L. D.

    Evaluation of four aerobiological sampling methods for the retrieval of aerosolized Pseudomonas syringac. App. Env. Microbiol. 1991, 57, 1268– 1270.

    OpenUrlAbstract/FREE Full Text
30. 30.↵
    1. Fierer N.,
    2. Liu Z.,
    3. Rodríguez-Hernández M.,
    4. Knight R.,
    5. Henn M.,
    6. Hernandez M. T.

    Short-term temporal variability in airborne bacterial and fungal populations. App. Env. Microbiol. 2008, 74, 200– 207.

    OpenUrlAbstract/FREE Full Text
31. 31.↵
    1. Heidelberg J. F.,
    2. Shahamat M.,
    3. Levin M.,
    4. Rahman I.,
    5. Stelma G.,
    6. Grim C.,
    7. Colwell R. R.

    Effect of aerosolization on culturability and viability of Gram-negative bacteria. App. Env. Microbiol. 1997, 63, 3585– 3588.

    OpenUrlAbstract/FREE Full Text
32. 32.↵
    1. Miller M. J.

    1. Homesley P. H.

    The RBD 3000 Rapid Bacterial Enumeration System as an Alternative to Traditional Pour Plate Enumeration. In Encyclopedia of Rapid Microbiological Methods—Volume 2; Miller M. J. Ed.; DHI Publishing: River Grove, IL and PDA: Bethesda, MD, 2005; pp 417– 435.
33. 33.↵
    1. Miller M. J.

    1. McCormick P. J.,
    2. Norton S. E.,
    3. Costanzo S. P.

    Validation of the ScanRDI for Purified Water Testing. In Encyclopedia of Rapid Microbiological Methods—Volume 2; Miller M. J. Ed.; DHI Publishing: River Grove, IL and PDA: Bethesda, MD, 2005; pp 317– 338.
34. 34.↵
    1. Ljungqvist B.,
    2. Reinmüller B.

    Airborne viable particles and total number of airborne particles: Comparative studies of active air sampling. PDA J. Pharm. Sci. Techol. 2000, 54 ( 2), 112– 116.

    OpenUrl
35. 35.↵
    1. Miller M. J.

    Evaluation of a continuous and instantaneous viable and nonviable environmental monitoring technology based on optical spectroscopy. 2008 PDA Annual Meeting—Science Driven Manufacturing: The Application of Emerging Technologies. Colorado Springs, CO; April 15, 2008.
36. 36.↵
    1. Miller M. J.

    Continuous and instantaneous viable and nonviable air monitoring using optical spectroscopy. ISPE 17th Annual Barrier Isolation Technology Forum: Innovation Updates and New Case Studies. Washington, DC; June 4, 2008.
37. 37.↵
    1. Buttner M. P.,
    2. Stetzenbach L. D.

    Monitoring airborne fungal spores in an experimental indoor environment to evaluate sampling methods and the effects of human activity on air sampling. App. Env. Microbiol. 1993, 59, 219– 226.

    OpenUrlAbstract/FREE Full Text