Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
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Rapid Microbiological Methods (RMMs)
A new paper shows thermal imaging (infrared thermography) can detect E. coli and S. aureus bacteria after just six hours of incubation, long before it is visible to the human eye.
Microbial detection methods are inherently flawed by three key factors, here we summarise Tim Sandle’s explanation of the concerns surrounding microbial methods and sampling.
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
29 July 2020 | By Charles River
In this webinar we discuss the results of our latest study where we evaluated the ruggedness, repeatability and specificity of commercially available rFC products, as well as our own recombinant product in development, against a large panel of endotoxins.
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.
In this issue is a discussion on the promise of virally vectored DNA and mRNA vaccines to combat COVID-19 as well as articles on how packaging could help to ensure patient adherence, regulatory issues for medicines and diagnostics during the pandemic and the benefits of digitalising the pharmaceutical supply chain.…
Many bacterial species have been found to exist in a viable but non-culturable state. Jeanne Moldenhauer discusses this phenomenon and makes suggestions as to why we don’t often see an increase in viable cells when using viability-based methods.
When it comes to microbial contamination testing, false results can waste valuable time.
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…