The Pharmaceutical Industry is Growing; the BioLumix System Can Help Your Lab Grow With it

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.Pharmaceutical Microbiological Testing 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.

Biolumix Microbiology SystemThe 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/

Rapid Microbiology Testing of Dairy Products using the BioLumix Instrument

Background

Testing Dairy Products using Rapid Microbiology with the BioLumix InstrumentCommercial Dairy Products need to be tested for microbial contaminants.  Dairy products include: cultured dairy products (kefir, cultured buttermilk, sour cream, and yogurt), cheeses (soft cheese products, semi-hard, hard, and extra hard cheeses), processed cheeses, butters, butter creams, dried milks, and ice creams.

Manufacturers require a simple, cost effective and rapid microbiological method to assess samples for the presence of specific organisms as an indication of the sanitary conditions.  The most common dairy microbiology tests include: Aerobic plate count, Yeast and Molds, Coliforms, and could also include some indicator of cold spoilage such as Pseudomonads.  Rapid and early testing for microorganisms can reduce product quarantine time, allows for faster response to contamination, decreases inventory holding and cold warehouse costs, and aids in prediction of product shelf-life for manufacturers.

Troublesome spoilage microorganisms include aerobic Psychrotrophic bacteria, yeasts, molds, heterofermentative lactobacilli, and spore-forming bacteria (Ledenbach and Marshall 2009).  Psychrotrophic bacteria can produce large amounts of extracellular hydrolytic enzymes, and the extent of recontamination of pasteurized fluid milk products with these bacteria is a major determinant of the milk products shelf life. Fungal spoilage of dairy foods is manifested by the presence of a wide variety of metabolic by-products, causing off-odors and flavors, in addition to visible changes in either color or texture and may also cause gassing.

BioLumix has developed a simple rapid microbiological method for the detection of various groups of bacteria, yeasts and molds.  The system can make the microbiology testing simpler, faster and automated, saving manufacturers time, labor and money. BioLumix has a comprehensive range of microbiological tests, including specific vials for Coliforms and Pseudomonas.  The system is designed to accelerate product release in a simplified automated approach.  Complete coliform test results are obtained within 12 hours with one vial substituting for nine or more MPN (Most Probable Number) test tubes.  Yeast and mold results are obtained in 48 hours rather than 5-7 days using plate methods.  Many products can be introduced directly into the BioLumix test vial without the need of a dilution step.  These include yogurts and sour cream, as well as milks.

BioLumix Applications

Yogurt Testing

Yogurt is a dairy product, which is made by blending fermented milk with various ingredients that provide flavor and color.  Manufacturers have responded to the growth in the yogurt market by introducing many different types of yogurt including low fat and no-fat, creamy, bio-yogurt, organic, baby, and frozen.  BioLumix has developed assay methods for measuring contaminating microorganisms in dairy products.

The yogurt can be directly added (Figure 1) into BioLumix vials to measure growth of Coliforms or Yeast and Molds.  Specialized high pH BioLumix vials can also be used for yogurt samples.  When a low pH yogurt sample is added to the BioLumix high pH Coliform vial (CC), the pH conditions become near neutral.  This ensures the yogurt manufacturer to be able to correctly test for coliforms using a direct (without dilution) sample of product.  As much as 1 gram of product can be directly tested in each BioLumix test vial.

Coliform organisms generally include four key groups of enteric bacteria.  They comprise of the following species: Escherichia, Citrobacter, Klebsiella and Enterobacter.  Each of these organisms can grow in the BioLumix high pH CC vial.  Figure 2 illustrates the growth of a coliform (Citrobacter) in the BioLumix CC vial (green) while the Dark Blue curve shows a clean sample.

A clear advantage of the BioLumix vial is that it can be used on the same work-day to yield data about the status of any contamination in dairy samples and thus enable the manufacturer to make a decision on the acceptability of the lot of product for sale and consumption.

Fermented Dairy Products

Yeast and Mold Testing: An example of the growth of a mold in cream cheese is shown below. Figure 3 illustrates the clean test result, using BioLumix Yeast & Mold vials, for the cream cheese product as shown in the Green curve.  The Dark Blue curve illustrates the growth curve in BioLumix YM vials when cream cheese was inoculated with the mold organism Geotrichum candidum.

Coliforms Testing:Similarly, testing of sour cream showed the lack of Coliforms in the product as illustrated in the Dark Blue curve in Figure 4.  The sour cream product sample was found to have other flora as shown by growth in the BioLumix TAC vial which detected total aerobic bacterial counts.  Thus, the BioLumix high pH CC vial was used to show selectivity for the presence or absence of Coliform organisms.

Rapid Detection of Pseudomonas in Dairy Products as an Indicator of Product Shelf-Life
Pseudomonad organisms are a major cause of bacterial spoilage of pasteurized milk and dairy products due to post process contamination.  Early detection of Pseudomonas in can be a predictor of product shelf-life as it is the predominant psychotropic bacteria present.  BioLumix has developed a rapid method for the detection of Pseudomonads in dairy products; the method is also applicable to detection of Pseudomonads in process water.

The BioLumix system was directly compared to the plate count methodology for milk samples stored at refrigerated temperatures and held overnight at room temperatures and to detected Pseudomonads in process water and other dairy products.

Commercial milk products were used to measure the presence of Pseudomonads during refrigerated and elevated temperature storage.  Pseudomonads were present at varying levels in dairy samples and were detected within 16-24 hours using BioLumix vials.  All process water samples tested were free of Pseudomonads by both methods.  Process water samples inoculated with different Pseudomonads strains were found to detect in the BioLumix system.  The vial were selective enough not allowing for growth of unrelated gram positive and gram negative bacteria, mold or yeast.  The combination of the Pseudomonas vial with overnight pre-incubation could serve as an indicator of shelf-life of products.

The data in this study suggests that the BioLumix Pseudomonas vials are capable of early detection of Pseudomonads in dairy products and in processing water. The system offers a reduction in time to results as compared to the plate methodology and eliminates any product interference.  It allows for rapid assessment of problems associated post processing problems.

BioLumix has developed a vial specific for testing of Pseudomonads that are known to commonly contaminate milk and also survive pasteurization, albeit in low numbers. These Pseudomonads may include P aeruginosa, P fluorescens, P putida, and P stutzeri.  Each of these species of pseudomonas was found to grow readily in the BioLumix PSE-B vials.

Summary

The BioLumix System is designed to accelerate product release with a simplified, automated approach.  This yields fast, accurate, real-time results while reducing costs and eliminates the time required for the assays to be completed.  The system offers real-time results of contaminated samples saving hours, possibly days.  The Coliform or Enterobacteriaceae results can be available within 12 hours; Yeast and Mold results within 48 hours.  Thus the BioLumix system allows for rapid detection of Coliforms and Yeast and mold.  For low coliform numbers, one vial can substitute for 9+ MPN tubes.  BioLumix will streamline and simplify the microbiological procedures, save labor and create a paperless laboratory, while generating results that correlate well with plate count methodology.

Reference
Ledenbach L. H. and R.T. Marshall. 2009 In “Compendium of the Microbiological Spoilage of Foods and Beverages” . Chapter Microbiological Spoilage of Dairy Products.

BioLumix System Saves Valuable Time in Yeast and Mold Testing

Rapid Microbiology Yeast and Mold TestingIf you are a microbiologist, or work in close relation with a laboratory, you probably already know that yeast and mold testing is one of the longest quality control processes. Both the plate count and the membrane filtration techniques used by many microbiology labs often take between 5-7 days to complete, and this ends up costing you and your organization valuable time and money in the mean time. The BioLumix rapid microbiology system is based on cutting edge knowledge of the microbial metabolic process, and is the most versatile method around when it comes to the expedient detection of microorganisms. For the nominal cost of our automated testing systems, your company could shave several days off of their production and distribution time, and secure a catalyst that will increase profits for years to come.

Yeasts and molds constitute a large and diverse group of microscopic foodborne fungi, totaling several hundred different species. One of the main reasons that these organisms are so successful in attacking foods and cosmetics is their versatility, having very broad temperature (5-60 ?C) and acid/alkaline (pH 2-pH 9+) requirements for growth. This means yeast and mold are capable of invading crops, such as those producing grains, nuts, beans, and fruits both before harvesting and during storage, and can also make their way into our processed food. In many cases Yeasts and molds are not immediately visible, however these fungi can cause varying degrees of deterioration and decomposition in products, with the manufacturer only discovering their presence when it’s too late.

Several different kinds of molds and yeasts can be hazardous to humans and animals due to their ability to produce toxic metabolites called mycotoxins. These metabolites are stable compounds, and the performed toxins are usually not destroyed during food processing, or even when cooking at home. Other yeasts and molds can also cause allergic reactions or infections, especially in immunocompromised demographics, such as the elderly, the young, the debilitated, or those undergoing antibiotic and chemotherapy treatment. To make matters worse, yeasts and molds often cause products to spoil after they have left the processing facility, posing potentially a health hazards and product quality issues to the consumers. For this reason, a wide range of industries require that companies test their products for yeast and mold before they go on sale. In a nutshell, the quicker you can produce and quality test products, the quicker you can get your inventory to market, and the more profitable you will be.

This value proposition is the premise upon which our rapid microbiological testing system was founded. The BioLumix system is committed to simplifying, expediting, and reducing the cost of performing microbiological assays so that companies can bolster production with a fraction of their current working capital. Our ready to use vials are capable of detecting yeast and mold in 48 hours, saving 3-5 days when compared to plate count and membrane filtration techniques and keeping more money in your pocket.

optical technology for yeast and mold testingThe keys to our systems celerity are its patented CO­­­2 sensors and optical technology, which continuously monitor growth media in each vial. Because yeasts and molds are obligate aerobes, they must take in oxygen and release Carbon Dioxide (CO­­­2) in order to grow. This cellular respiration is part of the Krebs cycle, and is used by all aerobic organisms to generate energy. When the sensor detects the presence of CO­­­2 it is a sign that microbial growth is present. The optical sensor simultaneously takes readings of the vials at 6 minutes intervals, detecting changes in color, and allowing for rapid detection of growth. Results are easy to interpret and can be automatically transmitted via a multitude of communication channels to its needed location, such as a warehouse or production facility to expedite shipping of a safe product. Our fully automated system can also be operated by a non-microbiologist, reducing labor by up to 60%, and allowing skilled scientists to spend their time in the lab more efficaciously. With less tedious work, microbiologists can turn their attention to higher value tasks, such as interpretation of data and product safety analysis, making your lab far more efficient.

With the BioLumix rapid microbiology system, labs can revolutionize the way that one conducts their quality control process. Our platform makes production times shorter, products safer, and recalls less frequent and far less costly. Adding value and increasing lab productivity with BioLumix will allow your organization to thrive, and will put you in a position to be successful for years to come.  

Simplified, Rapid, Automated Microbiology

Simplified, Rapid, Automated Microbiology – mybiolumix.com

Customer support and innovation are the cornerstones of the BioLumix business. Our mission is to assist our customers in their quality assurance by offering simplified, rapid, automated, reliable solutions for microbiological quality control and assurance. We’re always available to answer any inquiries regarding the system specifications, installation, validation, performance, benefits and cost savings. If you would like to speak with one of our experienced microbiologists or engineers, please contact us directly: (734) 984-3100

We are committed to delivering high value products, with a real technological difference, to satisfy our customer’s needs and help improve their quality assurance. We’re always available to answer any inquiries regarding the system specifications, installation, validation, performance, benefits and cost savings. If you would like to speak with one of our experienced microbiologists or engineers, please contact us directly: (734) 984-3100