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Rapid Microbiological Methods (RMMs)

 

article

European Pharmaceutical Review Issue 6 2021

16 December 2021 | By

This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…

article

Primary validation of the growth direct bioburden system and media

30 October 2020 | By , , , ,

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.

webinar

The analytical reality of recombinant endotoxin technologies

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.