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Rapid microbiological methods (RMMs) - Articles and news items
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.
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.
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.
Leveraging cutting-edge Rapid Microbiological Methods to gain a comprehensive understanding of your environment and a competitive advantage
Webinars / 5 February 2013 / BioVigilant
Gain 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
Webinars / 17 October 2012 / Rapid Micro Biosystems
Learn from experts where rapid technologies, like the Growth Direct™ System can have an impact on microbial quality control and ultimately manufacturing. Attendees of this free webinar will learn the limitations of the traditional methods, the importance of non-destructive testing and the benefits of automated, rapid detection.
Supplements / 24 September 2012 / Dr. Michael J. Miller
How the acceptance of rapid microbiological methods (RMMs) continues to be hampered by misconceptions, misunderstandings and myths.
Rapid micro methods and EMA’s post approval change management protocol.
Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations.
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). If you were able to attend one of these meetings, you probably found it encouraging and worthwhile listening to and speaking with end-users, regulators and vendors of the technologies. This year and next are no exception; scheduled conferences and training sessions within Europe and the US will provide the industry with a comprehensive overview and guidance on how to successfully implement RMMs. To give you a feel for what’s in store, this edition of our RMM series will highlight upcoming PDA and ECA RMM sessions. In addition, the last section will provide more information about the overall October 2012 PDA Global Conference on Pharmaceutical Microbiology, of which a number of RMM presentations will be delivered.
European Compliance Academy (ECA) Annual RMM Conference (December 2012):
This two-day conference offers you a unique opportunity to evaluate the new developments in RMM systems, to extend the current experi – ences in validation, as well as implementation of these systems within the pharmaceutical industry. Attendees will also learn about the expectations of the regulatory authorities and new developments with regard to regulatory requirements.
The latest innovation in rapid microbiology method instrument technology is real-time viable detectors…
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 that have been circulating throughout our industry are not true or have been exaggerated to the point that many companies continue to be hesitant in exploring what RMMs have to offer.
One of the most prominent myths is that the regulators do not understand, accept or even encourage the use of rapid methods. I submit to you that the regulators want to see RMMs implemented, as their use is directly aligned with the future state of pharmaceutical manufacturing, QbD, PAT and continuous process and product improvement. Further – more, recent changes to regulatory guidance and proposed policy have made it easier to implement RMMs than ever before. In my last article, I introduced a relatively new process that the European Medicines Agency (EMA) launched that allows for the review and approval of RMM validation strategies before testing is initiated. A more thorough review of this process, better known as the Post Approval Change Management Protocol (PACMP), is presented herein.
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 (RMMs), including:
– A review of the history of conventional micro – biology and the benefits of using RMMs
– Validation strategies
– Perspectives from the regulatory authori – ties, including FDA and EMA
– Overviews of currently available tech – nologies, including those based on the growth of microorganisms, detection of cellular targets, optical spectroscopy, nucleic acid amplification and gene sequencing, viability staining and laser excitation, as well as micro-electro-mechanical systems, or MEMS.
In addition to my articles, numerous companies have published their success stories of RMM selection, validation and implementation, for a variety of applications including, but not limited to, sterility testing, bioburden analyses, water testing, environmental monitoring and the detection of Mycoplasma and other micro – organisms.
This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of viability-based rapid microbiological methods (RMMs), such as flow and solid-phase cytometry. In this article, we will review some of the currently available RMMs that fall under the category of cellular-component based technologies. These RMMs rely on the analysis of cellular markers or the use of probes that are specific for microbial target sites of interest. Examples include ATP bioluminescence, the detection of endotoxin and the use of MALDI-TOF mass spectrometry for microbial identification.
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.