- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
Rapid microbiological methods (RMMs) - Articles and news items
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…
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…
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 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…
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.
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…
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
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.
This one-hour webinar discusses how the validation of rapid methods continues to be an obstacle to greater adoption of these technologies.
Improving the quantitation of live antigens used to produce rabbit generated serotype specific antiserum
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.
Webinar: Leveraging cutting-edge Rapid Microbiological Methods to gain a comprehensive understanding of your environment and a competitive advantage
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
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.
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