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Rapid Micro Biosystems announces the 2013 availability of Growth Direct™ Systems
New applications improve the efficiency of microbial quality control processes...
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Microbiology
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New year, old challenges!
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…
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Working independently or as part of a team: Which works best?
When I sat down to write this article, my immediate thought was about work styles. Is it better to work independently or in teams? Wouldn’t it be great to hear from someone on the ‘floor’ who has worked both in the lab and in the production environment? Work styles: independent…
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Detection of microorganisms using micro-electro-mechanical systems (MEMS)
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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Detection of microorganisms using optical spectroscopic-based rapid method technologies
31 August 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Previously, we discussed a number of cellular-component rapid microbiological methods (RMMs), such as ATP bioluminescence, fatty acid analysis, MALDI and SELDI time of flight mass spectrometry, Fourier transform-infrared…
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Inhibition of microbial growth in solid dosages at ICH stability storage conditions
31 August 2011 | By Linda Skowronsky, Senior Microbiologist, GlaxoSmithKline
Several intrinsic and extrinsic factors influence microbial growth. Two important factors include the presence of available moisture and a supportive temperature. The conditions described in ICH Topic Q1A (R2)1 do not allow the organisms of interest in pharmaceutical solids to grow, due to either an unfavourable temperature or humidity. For…
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Under the microscope: Steve Delity
Rapid Micro Biosystems is a privately owned, venture backed company with headquarters in Bedford, Massachusetts. Since launching its GrowthDirect™ System in 2008, the company has now moved into Europe with the opening of its new demo centre in Darmstadt, Germany in June 2011. So, how does CEO Steve Delity view…
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Detection of microorganisms using cellular component-based rapid method technologies
20 June 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
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…
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Article 2: Direct detection of microorganisms using viability-based technologies
19 April 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the second 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 growth-based rapid microbiological methods (RMMs). This was a good place to start my review of RMM technologies, as most…
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Article 1 Rapid microbiological methods 2011
16 February 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Last year, I provided an overview of rapid microbiological methods (RMMs), including validation strategies, regulatory expectations, the technical and quality benefits of RMMs as compared with conventional techniques,…
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The implementation of rapid microbiological methods
This is the sixth and final paper in a series of articles on rapid microbiological methods that have appeared in European Pharmaceutical Review during 2010. Over the past year, we have explored the world of rapid microbiological methods (RMMs), focusing on validation strategies, regulatory expectations, and the technical and quality…
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Article 5: The implementation of rapid microbiological methods
1 November 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives…
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Article 4: The implementation of rapid microbiological methods
19 August 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC
This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Believe it or not, today’s regulatory authorities encourage the use of rapid microbiological methods (RMMs), and when applicable, they have put policies in place that provide guidance on…
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Article 2: The implementation of rapid microbiological methods
9 May 2010 | By Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC
This is the second in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical…
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Microbiological quality for non-sterile drug product for the 21st century
22 February 2010 | By
For decades microbiological quality has remain dormant while the pharmaceutical industry has continued to evolve. Compendial methods and limits, while now generally harmonised throughout the world, still reflect the same methods utilised 100 years ago. Although there is more clarification around the number and types of organisms permitted in products…
