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RAPID METHODS SUPPLEMENT


should be chosen and applied to analyse the data in a RMM validation. The most probable number (MPN) method has been used quite often in microbial estimation with serial dilution experiment2,9


chi-square statistic model is applicable for a non-serial dilution method12,13


. REFERENCES


1. FDA. “Amendments to sterility test requirements for biological products.” Federal Register. 76 (119): 36019 – 36027


2. Garthright, W. G., and R. J. Blodgett. “FDA's preferred MPN methods for standard, large or unusual tests, with a spreadsheet”. Food Microbiol. 20:439-445 (2003)


3. Gray, J. C., Staerk, A., Berchtold, M., Hecker, W., Neuhaus, G., Wirth, A.“Growth promoting properties of different solid nutrient media evaluated with stressed and unstressed micro-organisms: prestudy for the validation of a rapid sterility test.” PDA Journal for Pharmaceutical Science and Technology. 64 (3): 249-263 (2010)


4. Miller, M.J. “Ensuring ROI from your RMM.” Pharmaceutical Manufacturing. 8(6): 32-35 (2009)


5. Monod, J. “The Growth of Bacterial Cultures.” Annu Rev Microbiol. 3:371-394 (1949).


6. PDA Technical Report No. 33 “Evaluation, validation and implementation of new microbiological testing methods” PDA J Pharm Sci and Tech, Volume 53 (3) Supplement TR33. (2000)


7. PhEur. 5.1.6. “Alternative methods for control of microbiological quality.” European Pharmacopoeia, 7.2 Rev.; European Directorate for the Quality of Medicines. Strasbourg, France: 2011


8. PhEur. 2.6.1. “Sterility” European Pharmacopoeia, 7.2 Rev.; European Directorate for the Quality of Medicines. Strasbourg, France: 2011


9. Smith, R., Von Tress, M. et al. “Evaluation of the ScanRDI® as a rapid alternative to the pharmacopoeial sterility test method: comparison of the limits of detection.” PDA J Pharma Sci Tech. 64(4): 356-363 (2009)


10. USP <1223> “Validation of alternative microbiological methods.” In United States Pharmacopeia, 34th Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2011.


11. USP <71> “Sterility Test” In United States Pharmacopeia, 34th Rev.; U.S. Pharmacopeial Convention, Inc.: Rockville, MD, 2011


12. van den Heuvel, E. “Estimation of the limit of detection for quantal response bioassays.” Pharm. Stat. 9 (2) (2010)


13. Verdonk, G.P.H.T., Willemse, M.J. et al. “The most probable limit of detection (MPL) for rapid microbiological methods.” J Microbiol Methods. 82 (3): 193-197 (2010)


14. Holms, W.H., Hamilton, I.D. and Robertson, A.G. The rate of turnover of the adenosine triphosphate pool of Escherichia coli growing aerobically in simple defined media. Arch Mikrobiol. 83(2): 95–109 (1972)


, while Pearson’s minimum


Summary Implementation of a RMM is a complex project which requires expertise from multiple fields such as finance, regulatory, microbiology, quality assurance, statistics and information technology. In addition to the internal effort, external advice from regulatory agencies and


active cooperation with vendors are imperative to the success of RMM implementation. Meanwhile regulatory agencies are striving to update the related regulations to endorse use of the most appropriate and state-of-the-art RMM for assuring the safety and rapid growth of pharmaceutical and biological products1


.


Tremendous potential remains for the development and implementation of RMMs with new concepts and technologies.


Acknowledgements The author appreciates the support of Dr. Edward C. Tidswell and John A. Williams.


BIOGRAPHY


Dr. Youwen Panis a research scientist at R&D Technology Resources / Sterility Assurance in Baxter Healthcare Corporation, Round Lake, IL, USA. His research involves hazard analysis of viable but non-culturable bacteria to the safety of sterile products, development


and evaluation of rapid microbial methods. He received a PhD degree in Microbiology and a MS degree in Food Microbiology from North Carolina State University. He managed a microbiology laboratory for the manufacturing of total parenteral nutritional products at Sino-Swed pharmaceutical Corp. LTD in Wuxi China for more than seven years.


Contact author: Youwen_pan@baxter.com


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