According to the United States National Institute of Health, there are nearly 140,000 clinical studies currently underway involving potential pharmaceutical products. Pharma is a huge industry, and companies both big and small are investing roughly $50 billion a year to get their products to market. This fervor spans some 200 countries, and with all this in mind it is no wonder that research has increased by an average of 28% each year since 2000. Still, whenever there are huge sums of money involved, people and companies can be enticed to hastily release their products, and this potential for microbial contamination in pharmaceutical products can have serious and far-reaching repercussions. The goal of the BioLumix Microbiological Testing System is to promote an expedient, automated, and efficient laboratory environment, allowing companies to increase their bottom line and ensuring that only safe products make it to the shelves.
Pharmaceutical microbiology is essential to the quality control process of any drug or supplement. Companies can spend immeasurable sums of time and money during this stage, and current plate count methods are incapable of providing labs with an avenue for advancement. BioLumix Rapid Microbiology Methods offer innovative new testing solutions that are designed specifically for the challenges of the pharmaceutical industry, including a multitude of microbial tests for raw materials, in-process and finished products, as well as the capacity to perform environmental testing. This simplifies, expedites, and reduces the cost of performing microbiological assays.
The key to the BioLumix System is its use of patented two-zone vials to monitor changes in a broth medium. At the top of each vial, an incubation zone allows a microbiologist to insert samples for testing, and at the bottom, a reading zone is utilized for the automated monitoring of up to 32 specimens by a single unit. Changes in color or fluorescence, which may be a sign of microbial growth, are expressed as light intensity units, which are detected by the systems optical sensor and recorded in its computer. Sample volumes of up to 2 ml can be used in each vial. Additionally, each vial slot features a dual-color Light Emitting Diode (LED) and a fluorescent tube that covers the full spectrum of colors and ultraviolet light. These two-zone vials eliminate the masking of the optical pathway by the products microbial turbidity, and because changes in color and fluorescence are monitored in the reading zone, results cannot be influenced by the sample or any of the microorganisms.
A few of the applications of the BioLumix System include total counts, yeast and mold, Bile tolerant gram negatives, and objectionable organisms. Results are easy to interpret and can be automatically transmitted to other locations, such as a company warehouse, to rapidly ship safe products. Perhaps one of the most convenient aspects of the BioLumix System is the fact that it can be easily operated non-microbiologists. This lessens the amount of tedious work for skilled lab-technicians, and allows them to shift their focus to higher value tasks.
In short, the BioLumix System allows pharmaceutical companies to perform as many tests as are needed to maintain a safe and beneficial product, without sacrificing time or money. Instead, for a one-time investment in BioLumix rapid microbiological method technology, your lab will be able to expedite its quality control process and decrease its overhead, allowing your company to expand in the growing market. The BioLumix rapid microbiology system will allow for increase capacity, logistical improvements and better efficiencies.
Recently Dr. Miller presented a web seminar about a case study of the implementation of the BioLumix system. To listen to this seminar click on the link http://cnpg.comparenetworks.com/144579-Implementation-of-New-RMM-BioLumix-Case-Study/