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Miller M.J.,Microbiology Consultants LLC
European Pharmaceutical Review | Year: 2012

There are a number of upcoming rapid method professional meetings geared toward supporting our industry, and those of you who are considering implementing rapid methods or are in the middle of validating new technologies should make every effort to attend at least one of these comprehensive scientific conferences and/or training sessions. This is your opportunity to meet and interact with fellow microbiologists, regulatory repre - sentatives, key product vendors and other global leaders in pharmaceutical microbiology and rapid microbiological methods. I hope to see you there! Source


The results from all of the testing between the RMM and the conventional or pharmacopoeial methods are comparable. Furthermore, the system demonstrates excellent specifi city (inclusivity and exclusivity), precision and the ability to detect levels of microorganisms that are equivalent or better than the conventional plate count method. The system is able to adapt to many diff erent microbiological applications, including, but not limited to, raw material assessments, in-process analysis and fi nished product testing, but especially for the compendial testing of nonsterile products. Finally, the ability of this novel RMM technology to provide both an estimation of cell count as well as testing for the presence or absence of specified microorganisms is a benefi t not available with most other rapid methods that are commercially available. The system has already been successfully used within the food, beverage, cosmetic, nutraceutical and dietary supplement sectors, and is now positioned to support the needs of the pharmaceutical industry as well. Source


Miller M.J.,Microbiology Consultants LLC
European Pharmaceutical Review | Year: 2010

This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality benefits of these novel systems as compared with conventional techniques. It should be obvious by now that RMMs will significantly impact the future of microbiology within the pharmaceutical and biotech industries. But don't just take my word for it. Source


Miller M.J.,Microbiology Consultants LLC
European Pharmaceutical Review | Year: 2011

Growth-based rapid microbiological methods provide opportunities for enhanced detection, enumeration and identification of microorganisms. Applications for these types of RMMs include, but are not limited to, raw material and component testing, in-process and pre-sterilisation/filtration bioburden, fermentation and cell culture monitoring, purified/process water testing, environmental monitoring, microbial limits, antimicrobial effectiveness testing and sterility testing. In my next article, we will explore the use of viabilitybased RMMs, including flow cytometry and solid phase cytometry. © Russell Publishing Limited, 2010, 2011. All rights reserved. Source


Miller M.J.,Microbiology Consultants LLC
European Pharmaceutical Review | Year: 2012

After reading this article, I hope you agree that most rapid method myths that have been circulating throughout the industry are just not true. Regulatory authorities want RMMs implemented, and their use is directly aligned with the future state of pharmaceutical manufacturing, QbD, PAT and continuous process and product improvement. There is validation guidance and this guidance will become clearer. Also, the cost of imple - mentation can be a good investment. So stop listing to the naysayers, cynics, sceptics and worrywarts, and embrace microbiology for the 21st Century. I have a feeling our friend Louis Pasteur would agree. © Russell Publishing Limited. Source

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