BioLumix Exhibits at 2013 PDA Annual Meeting in Orlando, FL

This year’s Annual PDA Meeting –will be held in sunny Orlando at The Peabody Hotel, April 15-17th.  This meeting focuses mainly on present-day manufacturing, challenges in the industry, and those we will face in the future.  The meeting is separated into three tracks so each attendee may pick and choose different areas to learn more about.  Additionally, several planned networking and social activities will bring all kinds of professionals together to ask questions, learn and get to know one another.

FDA Approval - Drug Master FileAttendees will have an opportunity to visit the BioLumix booth – # 404.  The BioLumix System is a rapid, automated microbiological method that is the only system capable of concurrently testing both USP <61> and <62>.  The system provides a single platform for testing raw materials, in-process, finished product, environmental swabbing and processing water.  BioLumix provides a complete screening solution with real-time communication for early warning of contaminated samples (in hours rather than days), results for bacteria in 12-24 hours and Yeast & Mold in less than 48 hours.  Once all testing is complete, an automated Certificate of Analysis is available and can be printed via the printer or connected to a LIMS system.

The BioLumix system, as described in the “Encyclopedia of Microbiological Methods Volume 4” edited by Dr. Michael Miller’s, in Chapter 7, simultaneously detects microbial growth, provides an estimation of viable cell counts and identifies the presence of specified microorganisms.  Additionally, BioLumix has contributed Chapter 14 of “Environmental Monitoring,” edited by Jeanne Moldenhauer, “Validation of a Rapid System for Environmental Monitoring and Water Testing.”  Both books will be available to review at the BioLumix booth #404.

By encompassing both USP chapters (61 and 62), the BioLumix is the all-in-one microbial testing solution for companies looking to save significant time, labor and resources.  The system will bring automation to the current microbial testing! The system is based on optical sensors that detect color of fluorescent changes in ready to use carbon dioxide sensing vials.  These vials eliminate the need to make, prepare and QC traditional media.

BioLumix has a DMF (Drug Master File) on file with the FDA for prescription pharmaceuticals.  For OTC (Over the Counter) products, the system is fully Validatable.  BioLumix installers will generate the IQ (Installation Qualification) and OQ (Operation Qualification) on-site during the 2 ½ day training session.  We will also work with your team to complete the side-by-side testing portion of the PQ (Performance Qualification), leaving your company with a complete Validation package.

Please stop by Booth #404 to speak with a BioLumix expert, view our recent publications, ask questions, get answers and join the growing customer base of BioLumix users! Learn how BioLumix Rapid Microbiology can deliver significant reduction in time to results, reduced staff involvement, leading to faster product release. . . and how these can impact your key “operational profit drivers.” We look forward to earning another satisfied customer.  See you soon at the PDA Annual Meeting!

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