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Dr. Michael J. Miller

 

Microbiology In-Depth Focus 2017

The European Pharmacopoeia chapter on methods for microbiological quality control…

19 October 2017 | By

The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.

A comprehensive review of the newly revised European Pharmacopoeia chapter 5.1.6

European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological…

31 August 2017 | By

European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…

RMMs In-Depth Focus

In this RMMs In-Depth Focus: the role of statistical analysis…

13 December 2016 | By

In this RMMs In-Depth Focus: the role of statistical analysis in validating rapid microbiological methods; considerations when using RMMs for use in pharmaceutical microbiology; & RMMs roundtable...

Towards the real application of rapid microbiological methods in developing countries

Rapid microbiological methods (RMM) have gained popularity and acceptance within…

22 October 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries

Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still…

The Encyclopedia of Rapid Microbiological Methods: The new fourth volume discusses technologies, regulatory acceptance and validation case studies

This is the second paper in our continuing series on…

13 June 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and rapidmicromethods.com

This is the second paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. As the editor for the Encyclopedia of Rapid Microbiological Methods, I provide a summary of the latest volume, which was published earlier this year. New case studies,…

Improving the quantitation of live antigens used to produce rabbit generated serotype specific antiserum

This is the first paper in our continuing series on…

21 February 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC, Silvia Fragoeiro, Ananthi Ramachandran and Paul van Empel MSD Animal Health

This is the first paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2013. Flow cytometry represents one of a variety of viability-based RMM technologies that are currently available to the pharmaceutical industry. In flow cytometry, individual particles are counted as…

Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring

This is the sixth and final paper in our continuing…

18 December 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used…

Rapid micro methods and the next generation in ATP bioluminescence

This is the fifth paper in our continuing series on…

25 October 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC and Noe Miyashita, Researcher, Hitachi Plant Technologies, Ltd

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…

Opportunities for rapid methods discussions: where the experts are meeting!

This is the fourth paper in our continuing series on…

3 September 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Over the past few years, a number of professional meetings have focused on strategies and case studies for the validation and application of rapid microbiological methods (RMM).…

Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations

This is the third paper in our continuing series on…

10 July 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for…

Rapid micro methods and EMA’s post approval change management protocol

This is the second paper in our continuing series on…

26 April 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the second paper in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. In my last article, we discussed a number of myths or misconceptions associated with the validation and implementation of rapid microbiological methods (RMMs). In fact, most RMM myths…

New year, old challenges!

This is the first of many articles in our continuing…

28 February 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the first of many articles in our continuing series on Rapid Microbiological Methods that will appear in European Pharmaceutical Review during 2012. For the past two years, I have enjoyed sharing with you a broad range of topics associated with the validation and implementation of rapid microbiological methods…

Detection of microorganisms using micro-electro-mechanical systems (MEMS)

This is the sixth and final article in our series…

13 December 2011 | By Michael J. Miller, President, Microbiology Consultants

This is the sixth and final article in our series on Rapid Microbiological Methods (RMMs) that have appeared in European Pharmaceutical Review during 2011. In our last article, we reviewed the world of nucleic acid amplification technologies, including PCR-DNA amplification, RNA-based reverse-transcriptase amplification, 16S rRNA typing and gene sequencing for…

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