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Rapid microbiological methods (RMMs) - Articles and news items

RMM In-depth focus

RMM: In-Depth Focus 2015

Issue 5 2015, Microbiology / RMMs, Supplements, Z Homepage promo / 22 October 2015 / David Roesti, Erik Wilkens, Mostafa Eissa, Hideharu Shintani

Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable…

Rapid methods update: revisions to a United States Pharmacopeia chapter

Rapid methods update: revisions to a United States Pharmacopeia chapter

Issue 4 2015, Microbiology / RMMs / 3 September 2015 / Michael J. Miller, PhD Microbiology Consultants, LLC

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…

Microbiology in-depth focus 2015

Microbiology in-depth focus 2015

Issue 3 2015, Microbiology / RMMs, Supplements, Z Homepage promo / 3 July 2015 / European Pharmaceutical Review

In this in-depth focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable…

Celsis Accel™ system, a rapid microbial screening system designed specifically to provide operational value to small and medium-size Pharmaceutical manufacturers.

Celsis introduces the all new Celsis Accel™ Rapid Microbial Screening System for midrange test volumes

Supplier news / 20 June 2015 / Celsis International

Celsis’ Accel System for Pharma allows products to be quickly released from micro hold, diminishing manufacturing cycle times and reducing inventory and working capital requirements…

RMM Webinar Featured Image

Webinar: Practical Application of RMM in Pharmaceutical Manufacturing

Microbiology / RMMs, Webinars / 15 December 2014 / Scott Sutton Ph.D. - President of Pharmaceutical Microbiology Forum & Owner of The Microbiology Network & Dr. Yongqiang Zhang - Senior Scientist at BD Diagnostics

Discussion on how a rapid method can provide a solution to a common microbiological testing problem for pharmaceutical manufacturers – process water microbiology testing.

RMM in-depth focus

RMM: In-depth focus 2014

Issue 5 2014, Microbiology / RMMs, Supplements / 5 November 2014 / Michael J. Miller, Deborah Gessell-Lee, Oliver Gordon, Joe Johnston, Neil Lewis, Jeanne Mateffy, Jeffrey W. Weber

Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable…

RMMs & Environmental Monitoring Supplement 2013 - 100

RMMs & Environmental Monitoring: In-depth focus 2013

Issue 4 2013, Microbiology / RMMs, Supplements / 21 August 2013 / Emanuele Selvaggio (Pfizer), Chris Delaney (Noonan Services Group)

The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.


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

Issue 3 2013, Microbiology / RMMs / 13 June 2013 / 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, regulatory guidance and novel technologies are highlighted, and encourage our industry to adopt new ways of performing microbiology assays across a wide range of applications.


Webinar: Validating a rapid method for pharmaceutical applications

Industry news, Webinars / 3 April 2013 / BD Diagnostics

This one-hour webinar discusses how the validation of rapid methods continues to be an obstacle to greater adoption of these technologies.

Fast quantitative 2D NMR for quantifying analytes in complex mixtures

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

Issue 1 2013, Microbiology / RMMs / 21 February 2013 / 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 they pass through a laser beam in a very narrow flow cell.

Azbil BioVigilant Product Logo 200x230

Webinar: Leveraging cutting-edge Rapid Microbiological Methods to gain a comprehensive understanding of your environment and a competitive advantage

Industry news, Webinars / 5 February 2013 / BioVigilant

This pharma webinar offers insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage

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Rapid micro methods and the next generation in ATP bioluminescence

Issue 5 2012, Microbiology / RMMs / 25 October 2012 / 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 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.

ATP bioluminescence is the generation of light by a biological process, and is most recognised in the tails of the American firefly Photinus pyralis. First discovered in 1947 by William McElroy, he described the ATP bioluminescence reaction in which ATP (Adenosine Triphosphate) is enzymatically consumed to produce light. Specifically, in the presence of the substrate luciferin, the enzyme luciferase will use the energy from ATP to oxidise luciferin and release photons (light at a wavelength of 562 nanometres). The photons can then be detected and measured by a luminometer equipped with a photomultiplier tube. Figure 1 provides an illustration of this chemical reaction.


Webinar: Fit-for-Purpose Miniature NIR Spectroscopy for Solid Dosage ManufacturingREGISTER TO WATCH
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