Rapid Microbiological Methods and the PAT Initiative - - BioPharm International

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Rapid Microbiological Methods and the PAT Initiative


BioPharm International


Disclaimer

There are reports of thousands of systems in development for use in place of traditional microbiological methods. This article introduces some of the technologies available. Inclusion or exclusion of methods is not meant to confer credibility, endorsement, or acceptance of one method over another. This article was condensed due to space limitations. It will be published in its entirety in an upcoming issue of BioPharm International.

Other Resources

There are a variety of other resources available for use by microbiologists in gaining information on RMM. A limited number of references are listed here for use:

Acknowledgements

Special thanks to Casey Costello and Vicky Strong for their aid in compiling this information.

Jeanne Moldenhauer, Vechtech Pharmaceutical Consultants, Inc.,24543 Indoplex Circle, Farmington Hills, MI 48335 248.478.5820, Fax: 248.442.0060,

References

1. Parenteral Drug Association. 2000. Technical Report 33, Evaluation, validation and implementation of new microbiological testing methods. J.Pharm. Sci. Technol. 54(3), Suppl. TR33 (May–June 2000).

2. Proposed Chapter <1223> Validation of Alternative Microbiological Methods, Pharmacopeial Forum, Vol. 29 (1) Jan-Feb 2003, 256 – 264.

3. FDA, September 2004, "Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach", Final Report – Fall 2004, Department of Health and Human Services, U.S. Food and Drug Administration.

4. FDA, September 2004, "Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach", Final Report – Fall 2004, Department of Health and Human Services, U.S. Food and Drug Administration.

5. FDA, Guidance for Industry – PAT A Framework for Innovative Pharmaceutical Development, Manufacture ad Quality Assurance, Government Printing Office, Rockville, MD, 2004.

6. PHARMEUROPA, October 2004. "5.1.6. Alternative Methods for Control of Microbiological Quality," 16(4): 555-565.

7. Kricka, L.J. "New Technologies for Microbiological Assays," in Rapid Microbiological Methods in the Pharmaceutical Industry, ed.M.C. Easter, Interpharm/CRC, Washington. D.C., 2003, p.233-248.

8. Rosen, D.L., Fell Jr., N.F. and Pellegrino, P.M., 2003, "Spectroscopic Detection of Bacterial Endospores Using Terbium Cation Reagent," In. Rapid Analytical Microbiology: The Chemistry and Physics of Microbial Identification, Edited by W. P. Olson, Bethesda, MD and Godalming Surrey, UK: Parenteral Drug Association and Davis Horwood International Publishing, Ltd., 230-235.

9. Rudi, K., "Application of Nucleic Acid Probes for Analyses of Microbial Communities," in Rapid Analytical Microbiology The Chemistry and Physics of Microbial Identification, Edited by W. P. Olson, Bethesda, MD and Godalming Surrey, UK: Parenteral Drug Association and Davis Horwood International Publishing, Ltd., 13-40.

10. DeSorbo, M.A.,"Rapid Contamination Detection Technology Patent Granted", http://www.cleanrooms.com/.


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