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Microbial Detection

 

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Methods for strain comparison and differentiation of environmental isolates

21 October 2022 | By

Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…

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Progress in the implementation of biofluorescent particle counters

24 August 2022 | By

Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…

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Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality

24 June 2022 | By , ,

New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…

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Testing non-inferiority for accuracy of quantitative microbiological methods

21 June 2022 | By , , ,

Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.