5. US Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. Rockville, MD: Office of Training and Communication; 2004. Available at: http:// http://www.fda.gov/cber/gdlns/steraseptic.htm.

6. US Food and Drug Administration. Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacture, and Quality Assurance. Rockville, MD: Office of Training and Communication; 2004. Available at: http:// http://www.fda.gov/cder/guidance/6419fnl.htm.

7. 5.1.6.: Alternative Methods for Control of Microbiological Quality. Pharmeuropa. 2004; 16:555-565.

9. DeSorbo MA. Rapid contamination detection technology patent granted. CleanRooms. August 2002. Available at: http:// http://cr.pennnet.com/Articles/Article_Display.cfm?Section=Archives&Subsection=Display&ARTICLE_ID=150543&KEYWORD=%22patent%20granted%22.

10. Corkidi G, Trejo M, Nieto-Sotelo J. Automated Colony Counting Using Image-Processing Techniques. In: Olson WP, ed. Rapid Analytical Microbiology: The Chemistry and Physics of Microbial Identification. Bethesda, MD and Godalming Surrey, UK: Parenteral Drug Association and Davis Horwood International Publishing; 2003.

11. Rosen DL, Fell Jr NF, Pellegrino PM. Spectroscopic Detection of Bacterial Endospores Using Terbium Cation Reagent. In: Olson WP, ed. Rapid Analytical Microbiology: The Chemistry and Physics of Microbial Identification. Bethesda, MD and Godalming Surrey, UK: Parenteral Drug Association and Davis Horwood International Publishing; 2003:229-240.

12. Meszaros A. Alternative Technologies for Sterility Testing. In: Easter MC, ed. Rapid Microbiological Methods in the Pharmaceutical Industry. Washington, DC: Interpharm/CRC; 2003:179-185.

13. Tools for microbiology. BioProbes. 2003;43:11-13. Available at: http://probes.invitrogen.com/lit/bioprobes43/4.pdf.

14. Chizhikov V, Rasooly A, Chumakov K, and Levy DD. Microarray analysis of microbial virulence factors. Applied and Environmental Microbiology. 2001; 67:3258-3263.

15. Westin L, Miller C, Vollmer D, et al. Antimicrobial resistance and bacterial identification utilizing a microelectronic chip array. J of Clin Microbiology. 2001; 39:1097-1104.

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17. Rudi K. Application of Nucleic Acid Probes for Analyses of Microbial Communities. In: Olson WP, ed. Rapid Analytical Microbiology: The Chemistry and Physics of Microbial Identification. Bethesda, MD and Godalming Surrey, UK: Parenteral Drug Association and Davis Horwood International Publishing; 2003:13-40.

ADDITIONAL RESOURCES

Additional resources are available as microbiologists gain information on rapid microbiology. These include the following:
• http://www.fda.gov/ has guidance documents on PAT, information on presentations, and other data.
• http://www.rapidmicrobiology.com/ includes information on vendors, technologies, press releases, etc.
• Rapid Microbiology User's Group (RMUG), with information available at http://www.vectech.com/ has resources and support information for seminars and newsletters.
• Pharmaceutical Microbiology Forum (PMF), http://www.microbiol.org/, is for pharmaceutical microbiologists. It includes an e-mail discussion group, virtual library, and information relevant to microbiologists.