Rapid Microbiological Methods and the PAT Initiative - Numerous new RMM systems are available to replace traditional testing methods - BioPharm International

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Rapid Microbiological Methods and the PAT Initiative
Numerous new RMM systems are available to replace traditional testing methods


BioPharm International
Volume 18, Issue 12

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.

8. Kricka LJ. New Technologies for Microbiological Assays. In: Easter MC, ed. Rapid Microbiological Methods in the Pharmaceutical Industry. Washington, DC: Interpharm/CRC; 2003:233-248.

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.

16. Busit E, Bordoni R, Castiglioni B, et al. Bacterial Discrimination by Means of a Universal Array Approach Mediated by LDR (Ligase Detection Reaction). BMC Microbiology. 2002; 2:27. Available at: http://www.biomedcentral.com/1471-2180/2/27.

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.


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