University to Implement ABV's Rapid Microbial Monitoring System
The University of Tennessee Pharmaceutical Sciences Department will start using Azbil BioVigilant's IMD-A® 300-series of rapid microbial monitoring systems in their state-of-the-art aseptic filling facility. The IMD-A 300 and IMD-A 350 systems can immediately detect the presence of microbes in the pharmaceutical manufacturing process, and in doing so, greatly accelerate the quality assurance processes for drug batch release.
The University of Tennessee is a leading institution in training individuals in health sciences fields, and for the past 50 years, has offered training in aseptic processing. Our new manufacturing facility, now under construction, will provide an advanced training ground featuring cutting-edge technology such as Azbil BioVigilant's IMD-A system capable of real-time, around-the-clock environmental monitoring, said Professor Laura Thoma, Director of UT's Plough Center for Sterile Drug Delivery. This laser-based technique leverages naturally-occurring fluorescence to detect microbes, in contrast to the culturing method in widespread use developed over a century ago, she added.
Aric Meares, CEO of Azbil BioVigilant, stated partnerships such as these signify enabling steps for the industry. The FDA continues to encourage the adoption of new technologies that improve the sterile manufacturing process and reduce the contamination risk to medications. The pharmaceutical industry has made limited advancements in this area due, in part, to the lack of published data. Our partnership with the University of Tennessee will help to fill that information void, he added.
The University aims to complete research on topics of wide interest to pharmaceutical drug makers such as the relevance and impact of paradigm-changing microbial detection sensitivity via intrinsic fluorescence, the impact of rapid access to information warning of a change of state within the drug-making environment, and the use of IMD-A systems as part of a larger parametric (or real-time) product release process.
Tags: Environmental Monitoring, FDA
Date Published: April 8, 2013 » company contact details
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