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Search result for "biovigilant" – 19 articles found

BioVigilant introduces Instantaneous Microbial Detection for pharmaceutical water monitoring

Supplier news / 14 October 2014 /

Azbil BioVigilant, inventors of Instantaneous Microbial Detection™, announced the introduction of its new IMD-W™ rapid microbial detection system for real-time water monitoring of pharmaceutical water sources…

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Azbil BioVigilant (ABV) announces partnership with University of Tennessee (UT) Pharmacy College

News, Supplier news / 4 April 2013 /

UT to implement ABV’s rapid microbial monitoring in new aseptic processing area…

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Azbil BioVigilant interviewed at PDA 7th Annual Global Conference on Pharmaceutical Microbiology

Videos / 4 December 2012 /

Aric Meares, CEO, Azbil BioVigilant speaks to Freddy White at PDA 7th Annual Global Conference on Pharmaceutical Microbiology.

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Azbil BioVigilant announces decision to deploy IMD-A rapid microbial monitoring system by compounding pharmacy innovator

News, Supplier news / 8 October 2012 /

Leiter Rx will utilize Azbil BioVigilant’s IMD-A® 300-series systems…

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Azbil BioVigilant to distribute BioTrends data management software

News, Supplier news / 18 September 2012 /

Azbil BioVigilant has entered into a distribution agreement with Archilex…

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Under the microscope: Aric Meares, CEO, Azbil BioVigilant

Issue 2 2012, Under the Microscope / 26 April 2012 /

Want to avoid a devastating drug shortage? Aric Meares, CEO of Azbil BioVigilant, says rapid microbial detection technology is a critical part of the solution…

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RMM: In-Depth Focus 2015

Issue 5 2015, Microbiology / RMMs, Supplements / 22 October 2015 /

Implementation of a rapid methods portfolio at a pharmaceutical manufacturing site; Use of RMMs in quality control: challenges and benefits; Rapid assay for bioburden and other contaminations; RMM Roundtable…

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RMM: In-depth focus 2014

Issue 5 2014, Microbiology / RMMs, Supplements / 5 November 2014 /

Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable…

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RMMs & Environmental Monitoring: In-depth focus 2013

Issue 4 2013, Microbiology / RMMs, Supplements / 21 August 2013 /

The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.

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Leveraging cutting-edge Rapid Microbiological Methods to gain a comprehensive understanding of your environment and a competitive advantage

Industry news, Webinars / 5 February 2013 /

This pharma webinar offers insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage

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IFPAC®-2013

News, Supplier news / 14 January 2013 /

IFPAC is the essential meeting place for the latest developments in Process Analytical Technology…PAT and Quality by Design…QbD…

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Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring

Issue 6 2012, Microbiology / RMMs / 18 December 2012 /

This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used my own blog (http://blog.rapidmicromethods.com) to communicate technology advances and changes to regulatory and validation practices and expectations. In my final article of the year, I am providing an overview of two very interesting topics that have sparked additional discussions within the professional community: the proposed changes to USP’s informational chapter on the validation of alternative microbiological methods and real-time environmental monitoring.

Revision to USP Chapter <1223>: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms such as RMMs.

Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.

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