Microbiology Consultants LLC

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Microbiology Consultants LLC

United States

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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.


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.


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.


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!


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

It is obvious that sweeping changes to the finished product sterility test for biologies have been put in place, and I applaud the FDA for thinking outside the box in providing guidance on novel microbiological technologies for this purpose. I am also encouraged with companies that manufacture the types of products, which are covered by the Final Rule, who have already validated and implemented RMMs as alternatives to the compendial sterility test. These changes will certainly encourage others in the industry to adopt rapid methods, not only for sterility testing, but also for all other microbiological applications that we are currently required to perform.


Miller M.J.,Microbiology Consultants LLC | Miyashita N.,Hitachi Ltd.
European Pharmaceutical Review | Year: 2012

This is the fifth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. As many of you know, I am always on the lookout for the next generation of rapid microbiological method (RMM) technologies and solutions. In this article, I have invited Noe Miyashita, a researcher from Hitachi Plant Technologies, to describe a novel ATP bioluminescence technology platform that she and her colleagues are currently working on. But in order to frame this discussion, it is appropriate to provide some background material on the fundamental basics of ATP bioluminescent methods.


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

The implementation of RMMs represents significant progress toward the acceptance of microbiological PAT and QbD solutions for the industry, and is directly aligned with the expectations for pharmaceutical manufacturing, quality and operational excellence in the 21st Century. Whether a firm plans on satisfying the expectations of the FDA, EMA or any other regulatory agency, it is still important to discuss your RMM qualification and implementation plans early in the design phase to ensure that the best strategy is agreed upon. You may even find that the use of a PACMP or Comparability Protocol may not even be required, depending on the rapid method technology, its application(s) and/or the products or materials on which the RMM will be used. This may be most applicable for test samples and their specifications that are not included in a regulatory dossier, such as in-process sample matrices. © Russell Publishing Limited, 2010-2013. All rights reserved.


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.


Miller M.J.,Microbiology Consultants LLC
European Pharmaceutical Review | Year: 2015

From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency's and US Food and Drug Administration's expectations, implementation strategies, scientific principles behind the technologies and validation. The final article of the 2012 series introduced the United States Pharmacopeia's (USP's) plan to revise informational chapter <1223>, Validation of Alternative Microbiological Methods.1 On June 1, 2015, a substantially modified chapter <1223> was published in the second supplement to USP38/NF33 with an official date of 1st December 2015. Because the original USP chapter was published almost 10 years ago, this article will review the most notable changes and compare them with what is recommended in the Parenteral Drug Association (PDA) Technical Report Number 33 and the proposed revision to European Pharmacopoeia (Ph. Eur.) chapter 5.1.6. © 2015 Russell Publishing Limited.


Volume IV of the Encyclopedia of Rapid Microbiological Methods provides new insights, validation and implementation guidance, and most importantly, encourage - ment for the pharmaceutical industry to embrace the next generation of microbiology testing plat forms and strategies. Volume IV may be ob tained through the PDA at https://store.pda.org/ProductCatalog/Product. aspx?ID=1899. Volumes I-III may be accessed at https://store.pda.org/ProductCatalog/Product. aspx?ID=513.

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