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Rapid microbiological methods (RMMs) - Articles and news items

Microbiology In-Depth Focus 2016

Microbiology: In-Depth Focus 2016

Issue 3 2016, Microbiology / RMMs, Supplements, Z Homepage promo / 30 June 2016 / European Pharmaceutical Review

Featuring: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable.

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Emerging trends in microbiological diagnostics: an introduction to rapid microbiological methods

Blog / 29 January 2016 / Adewale Joseph Ogunleye, Adekunle Ajasin University, Akungba Akoko, Ondo State, Nigeria

This article explores how scientists are developing a fast, qualitative and specific technique for the detection and classification of microorganisms…

Whitepaper: Feasibility of a Rapid Microbiological Method for filterable raw materials

Whitepaper: Feasibility of a Rapid Microbiological Method for filterable raw materials

Whitepapers / 15 January 2016 / Merck Millipore

The Milliflex® Quantum system (Merck Millipore) is a rapid method for the quantitative detection of contaminants in filterable samples…

Application Note: MALDI-ToF Mass Spectrometry - A valid alternative for microbial identification - Wickham Labs

Application Note: MALDI-ToF Mass Spectrometry – A valid alternative for microbial identification

Whitepapers / 11 January 2016 / Wickham Laboratories Limited

MALDI-ToF mass spectrometry, a phenotypical RMM for microbial identification, is a unique, highly accurate alternative method that facilitates cost-effective, precise and rapid data acquisition…

RMM In-depth focus

RMM: In-Depth Focus 2015

Issue 5 2015, Microbiology / RMMs, Supplements / 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 / 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

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.

clinical-trials-regulation

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.

 

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