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Growth Direct Passes Rigorous Analytical Validation

July 30, 2018 By Rapid Micro Biosystems

At this year’s PDA Europe Annual Meeting, held in Berlin, June 26-27, 2018, Rapid Micro Biosystems delivered the poster presentation “Primary..

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RMM Validation – The Role of Quality Assurance

March 5, 2014 By Rapid Micro Biosystems

For pharmaceutical manufacturers, growth-based RMM technologies allow for comprehensive, high-volume tests with streamlined validation. Still,..

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Installation and Qualification of The Growth DirectTM System

February 25, 2014 By Rapid Micro Biosystems

Previously, we discussed the validation requirements for rapid microbial methods, comparing and contrasting alternative methods from growth-based..

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Understanding Validation Requirements of Rapid Methods

February 20, 2014 By Rapid Micro Biosystems

When companies evaluate rapid methods for use in their microbial quality control testing, one area that can often cause confusion is the..

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The Growth Direct System -- what do the regulators think?

November 19, 2012 By Admin User

In the months since we announced the 2013 availability of the Growth Direct™ System for multiple applications we have received a lot of positive..

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Equivalency Tests & Rapid Method Validation or “Lies,damn lies,and statistics”

August 13, 2010 By Admin User

To the non-statistician, such as me, statistics can be a murky place, with its own set of jargon, tests and procedures.  In the wrong hands,..

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