rapid sterility testing

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Nelson Labs: supporting internal quality processes

14 May 2019 | By Nelson Labs

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,…

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Rapid sterility testing and the impact of recent changes to the US Code of Federal Regulations

10 July 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the third paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Rapid sterility testing is one of a number of applications that novel microbiological technologies afford the pharmaceutical industry. RMM technologies have already been validated and implemented for…

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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…