International Dairy Show 2013

November 3–6, 2013 | McCormick Place | Chicago, Illinois
www.dairyshow.com
BioLumix will exhibit in the International Dairy Show in Chicago, IL, showing how BioLumix can make the microbiological testing simpler, faster, and automated – saving your company time, labor and money and offering a comprehensive range of microbiological tests for raw ingredients and finished products, as well as processing water and environmental testing.

BioLumix Exhibits @ SupplySide West 2013 – Stop by Booth # 30038!

SupplySide WestSupplySide West brings together the suppliers and buyers that drive the dietary supplement, food, beverage, animal nutrition, personal care and cosmetic marketplace. Key professionals and thought leaders from executive management, R&D, QA/QC and marketing teams will meet in Las Vegas November 12-16.  The 2013 show floor is the largest yet, featuring over 1,700 booths, please make sure that you visit BioLumix at Booth #30038.

Rapid automated methods, such as the BioLumix System, can speed up time to results from 7-10 days to 1-2 days.  The time saved has a direct impact on many operational profits drivers. . . and is The reason over 450 BioLumix Systems are actively being used by many of the largest manufacturers in the industry.

Here are just a few of the many benefits of the BioLumix Partnership Program:

Ready-to-use vials  with specialized media which do not require QC on your end

Very Fast Results—C of A within 48 hours  for expedited product releases

Simplified, automated microbiology testing

    • Paperless laboratory
    • 60% savings in labor
    • Operated by non-microbiologist

ALL assays available within one automated system

Validated Method in compliance with USP <2021>, <2022>, <2023> and USP <61>   and <62>

Remote access/support for your system via internet and interactive phone calls to facilitate optimal instrument performance

Product reports tailored to specific applications

Dedicated microbiologist assigned to support your    facility

Real-time continuous support for reviewing microbiology assays. . .  and more

BioLumix takes pride in delivering the highest level of customer support for our BioLumix Partners.  Did you know that in a recent customer satisfaction survey, ALL of our customers would recommend us to their vendors, suppliers and customers?

With the BioLumix System, we can help your company internalize microbiology testing.  If you already have an internal laboratory, we can help you save time and money by automating your testing!  Many of our customers have gone through audits and we have received great feedback from them.

biolumix automation drives profitsWe welcome all of our customers to stop by and say hello!  If you are not yet a customer, we welcome the opportunity to work with you.  Our jobs center around satisfying our customers and providing unparalleled support.  We would be happy to give you a demonstration of the system including testing your samples for free.  After all, we wouldn’t want to sell you a product that doesn’t work for you.  Still not convinced?  We would be more than happy to provide you a long list of customer referrals.  Allow us the opportunity to demonstrate the many benefits of the BioLumix Partnership Program.

Dealing with difficult to read plates or manual data transfer is a thing of the past. With automated monitoring of ready-to-use assay vials and automated data processing and archiving (paperless), the microbiologist‘s job got a lot easier with the same accurate results in less than half the time.  Real-time data communication: Early warning of contaminated samples as well as sample release information could be automatically communicated through your intranet, significantly improving your company’s efficiencies.  BioLumix system can be used to test powders, oils, enzymes, botanical material, tablets, capsules, powders and liquids easily and without product interference.

BioLumix trainers will provide each customer with a full and customized Validation book, during the two and a half days of on-site training and installation of the system, including installation qualification, Operation Qualification and Performance qualification.

With this internal automated microbiological system, customers have control over their testing, leading to accurate results and accelerated product release while reducing costs.

The BioLumix Rapid Microbiology System can save multiple days versus current USP testing methods, and dramatically impact key profit drivers, such as elimination of idle time with raw materials, work in progress, and finished goods.

2013 PDA’s 8th Annual Global Conference on Pharmaceutical Microbiology

October 21st – 23rd, 2013 | Bethesda North Marriott Hotel | Bethesda, Maryland
www.pda.org
October 21-23, 2013 in Bethesda, Maryland at the Bethesda North Marriott Hotel. The event will bring together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that our industry faces on a daily basis. The comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.

International Dairy Show 2013

International Dairy Show 2013
November 3–6, 2013, McCormick Place • Chicago, Illinois

International Dairy Show 2013The International Dairy Show is back in Chicago and is bigger, and better than ever. Dairy, food and beverage processors will see technology and innovations in formulation, processing, packaging, distribution, food safety, and more. Operations, research, and sales and marketing teams will attend to learn trends, cost-cutting innovations, and ways to deliver more value to your customers. We at BioLumix wanted to take this opportunity to invite you to our exhibit (booth #452) and show you what’s new at BioLumix. We continue to innovate, growing our assay repertoire and capabilities.
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 you 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.
Dairy product Testing for Yeast and Mold and Coliform
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.

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.

Rapid Detection of Pseudomonads in Dairy Products as an Indicator of Product Shelf-Life The data presented in this study suggested that the BioLumix Pseudomonas vials are capable of early detection of Pseudomonads in dairy products and in process water. The system offered a reduction in time to results as compared to the plate methodology and eliminates any product interference. It allows for rapid assessment of any post processing associated problems.

The BioLumix Advantage
• Vial design prevents product interference
• Automation and connectivity allows faster product release
• Real-time communication for immediate action
• Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours
• Automated data archiving and audit trail
• Streamlined testing increases laboratory efficiencies
• Paperless laboratory: centralized test data automatically stored and protected
• Barcode capability for automated sample entry
• Environmental testing made easy

Free Product Trial
Give us your most difficult samples and we will test them for free. We will provide you with a detailed report which includes a side-by-side comparison to your current manual methodology. The data generated is strictly confidential and is only used to show the high correlation of results should your company decide to purchase.

We look forward to working with you and earning another satisfied customer!

PDA’s 8th Annual Global Conference on Pharmaceutical Microbiology

October 21-24, 2013 | Bethesda North Marriott Hotel | Bethesda, Maryland; Exhibition: October 21-22

PDA’s 8th Annual Global Conference on Pharmaceutical Microbiology brings together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that the Pharmaceutical industry faces on a daily basis. During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies, providing invaluable sessions dedicated to pharmaceutical microbiology.  Visit the BioLumix booth (#13) to learn about the most advanced rapid microbiological testing system.

advanced rapid microbiological testing system
Rapid Automated USP <61> and <62> on a single Platform
BioLumix Rapid Microbiological System is capable of performing testing equivalent to both USP <61>and <62> simultaneously on a single platform. The novel automated growth-based system simultaneously detects microbial growth, provides an estimation of viable cell counts, and identifies the presence of specified micro-organisms. By encompassing both USP types of testing, the BioLumix is a complete screening solution making the existing microbial testing simpler, faster, and automated – saving your company significant time, labor and money. BioLumix has a DMF on file with the FDA, and the system is easy to validate due to growth based format using traditional USP media.

Adding Speed and Automation to Microbiological Testing – The Automated BioLumix System will accelerate your microbiological testing resulting in faster product release and decreased costs. The streamlined testing design reduces labor, time and supplies. The BioLumix software is 21 CFR Part 11 compliant with log-in, log-out and audit trail. The BioLumix Rapid Microbiology System can save multiple days versus current USP testing methods, and dramatically impact key profit drivers, such as elimination of idle time with raw materials, work in progress, and finished goods. The time saved has a direct impact on many operational profits drivers. . . and is The reason over 400 BioLumix Systems are actively being used by many manufacturers.

Here are just a few of the many benefits of the BioLumix System:

  •  Simplified, automated microbiology testing
  •   Paperless laboratory
  •   60% savings in labor
  •   Real-time continuous support for reviewing microbiology assays.

We welcome all of our customers to stop by and say hello!  If you are not yet a customer, we welcome the opportunity to work with you.  Our jobs center on satisfying our customers and providing unparalleled support.  We would be happy to give you a demonstration of the system including testing your samples for free.  After all, we wouldn’t want to sell you a product that doesn’t work for you.  Still not convinced?  We would be more than happy to provide you a long list of customer referrals.

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.  

RMM Implementation – BioLumix Case Study

With modern labs requiring higher levels of efficiency and lower investment of working capital, many microbiologists recognize the tremendous benefits of rapid microbiology methods (RMM).

Faster contamination response times, quicker product releases, and automated data capture will bolster the key profit drivers of any organization. The BioLumix platform conducts the tedious tasks for you, allowing microbiologists to focus on higher value tasks and saving money in the process.

On September 12th, Dr. Michael J. Miller, President of Microbiology Consultants, LLC, hosted a web seminar entitled: Implementation of New RMM – BioLumix Case Study. Miller is an internationally recognized expert in pharmaceutical microbiology, contamination control, GMPs, pharmacopoeia compliance, and rapid microbiological methods, among others. The presentation is a rare chance to engage with industry information at no cost, and is streamed by the American Pharmaceutical Review and is available on demand. To listen to the presentation, fill out the form below.

Pharmaceutical Microbiology

Pharmaceutical Microbiology

BioLumix offers innovative microbiological testing solutions designed specifically for the Pharmaceutical industry. We offer a comprehensive range of microbiological tests for raw materials, in process and finished products as well as environmental testing. 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) 365-7500

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) 365-7500

 

3928 Varsity Dr.
Ann Arbor, MI 48108

Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com

http://www.mybiolumix.com/
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2013 IAFP Annual Meeting

July 28-31, 2013 | Charlotte Convention Center | Charlotte, North Carolina
www.foodprotection.org/annualmeeting
The IAFP Annual Meeting is attended by more than 2,500 of the top industry, academic and governmental food safety professionals from six continents. This renowned event owes its reputation and success to the quantity, quality and diversity of each year’s program; the quality and relevance of exhibits sharing the latest in available technologies; leading experts speaking on a variety of timely topics; and special recognition of outstanding professionals and students for their contributions in the food safety field.

Automated Microbiology Testing is the Key to Laboratory Growth in the 21st Century

Modern microbiology laboratories demand efficiency, and that means constantly improving data quality and lab productivity while simultaneously shortening time to results, and lowering the manufacturing cycle. This works by lowering the required working capital investment through faster release of inventory. As microbiologists become swamped with higher and higher volumes of work, traditional paper-intensive manual plate methodologies are becoming a thing of the past, and automated technology now holds the key to future growth. 

Manual systems are tedious and labor intensive; they are susceptible to transcription errors, and require skilled lab technicians to spend excessive amounts of time performing simple, monotonous tasks. Twenty years ago, when automated microbiological testing systems were not available, this elongated time to results and plodding flow of information was a necessary evil; with the rapidity of technological advancement in the 21st century, this is no longer the case. Automated microbiological testing systems are equipped with flexible electronic designs, allowing lab personnel to more efficiently manage, review, store, and report the high volume of analytical information needed for microbiology quality assurance. Repetition of the same task again and again is often the source of inconsistent results, but automation significantly reduces the chances of human error as well as the risk of lost data, resulting in huge productivity gains for manufacturers and laboratories. In this way, automation can provide companies with a higher level of quality assurance while requiring far less labor, and this equates to a greater profit margin.

In today’s economic climate, automation is essential in order to streamline workflows and ensure a quality product. Expedition of lab work through automation is changing the way that modern microbiology labs function, and the companies that utilize these new microbiology instruments are becoming more productive than ever before. The BioLumix system brings automation to current microbiological testing, providing a new generation of microbiology labs with the tools they need to excel and overcome their challenges. The system operates by using optical sensors, which detect color and fluorescent changes in ready to use carbon dioxide sensing vials, eliminating the need to make, prepare, or quality control traditional media. Automated sample tracking and data management also allows for the safe and immediate transfer of information in a paperless format.

With many labs bereft of a large number of qualified technicians, and subject to a great deal of pressure to analyze a higher volume of samples and deliver rapid results, the BioLumix automated microbiological testing system does the tedious work for you, and can be easily operated by a non-microbiologist. All in all, this equates to a 60% savings in labor, and this newfound time can be utilized by laboratory personnel to perform higher value tasks, such as the interpretation of results and diagnoses of potential problems as early as possible. We have all heard the old adage “time is money,” and that is where the BioLumix rapid testing system truly shines. Simply put, faster detection of microbial contamination results in faster corrective action, and that saves money. A nominal investment in an automated testing system will save your lab valuable days in their quality control process, and can reduce time to results from 7-10 days to 1-2 days. If contaminants are found, products can be recalled much earlier, and manufacturers can quickly take action to substitute raw materials that do not meet specifications. They can also resume production of a high quality product much earlier, which means that a single incident of faster intervention can save more than the cost of an automated rapid testing system.  Speeding up microbiology testing results in the speeding up of production and the reduction of inventory. By implementing a rapid micro method, you can re-allocate new found floor space to increase manufacturing capacity, add more SKU’s to inventory, or reduce distribution center costs.

The BioLumix automated microbiology testing system is easy to use, and can be utilized by modern laboratories to ensure quality products, speed up production, reduce labor, and increase manufacturing capacity by enabling a rapid release of inventory. With a lower working capital investment, and a more efficacious use of microbiologists’ skills, automating with BioLumix will have a profound affect on any organization’s key profit drivers, and may very well be the key to their growth in the 21st century marketplace.

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

Biolumix Microbiology experts at IAFP in Charlotte NC July 28– 31

The 2013 Annual International Association of Food Protection— Provides attendees with information on current and emerging food safety issues. Participants will be introduced to the latest science, and have a chance to become versed in innovative solutions to new and recurring problems in the food industry. In addition, they will have the opportunity to network with thousands of food safety professionals from around the globe. The IAFP Annual Meeting is attended by more than 2,500 of the top industry, academic and governmental food safety professionals, hailing from six continents. IAFP is famous for their quality and relevance of exhibits, sharing the latest in available technologies; leading experts speaking on a variety of timely topics; and special recognition of outstanding professionals for their contributions in the food safety field.
All of us here at BioLumix want to take this opportunity to invite you to our exhibit (booth #308) and show you what’s new at BioLumix. We continue to innovate, growing our assay repertoire and capabilities – allowing you to perform all required assays on raw ingredients and finished products, as well as test environmental samples and process water.

During the IAFP show we will feature our poster:  Rapid Detection of Pseudomonads in Dairy Products as an Indicator of Product Shelf-Life. The data presented in this study suggests that the BioLumix Pseudomonas vials are capable of early detection of Pseudomonads in dairy products and in processed water. The system offers a reduction in time to results as compared to the plate methodology and eliminates any product interference. In this way, it allows for rapid assessment of any post processing associated problems.

With automated monitoring of ready-to-use assay vials, along with automated data processing and archiving, the microbiologist’s job gets a lot easier with the same accurate results in less than half the time.  Our innovative vial design prevents product interference even when directly testing products, such as yogurt and salad dressing.  Come to our booth (#308) or contact us directly (734-984-3100) to learn more about the exciting new developments we are featuring at this year’s IAFP.

 

 

The BioLumix Advantage

• Vial design prevents product interference

• Automation and connectivity allows faster product release

• Real-time communication for immediate action

• Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours

• Automated data archiving and audit trail

• Streamlined testing increases laboratory efficiencies

• Paperless laboratory: centralized test data automatically stored and protected

• Barcode capability for automated sample entry

• Environmental testing made easy

 

Free Product Trial

Give us your most difficult samples and we will test them for free.  We will provide you with a detailed report which includes a side-by-side comparison to your current manual methodology.  The data generated is strictly confidential and is only used to show the high correlation of results should your company decide to purchase.

 

We look forward to working with you and earning another satisfied customer!

Microbiology of Dietary Supplements

Official Methods for Dietary Supplements

The USP methods for dietary supplements include:

USP <2750> Manufacturing Practices for Dietary Supplements: Contains the official FDA ruling on dietary supplement cGMPs (21 CFR Part 111).

USP <2021> Microbial Enumeration Tests-Nutritional and Dietary Supplements: Enumeration of the total number of aerobic bacteria, enumeration of the total number of combined yeast and molds, and the presence of bile-tolerant gram negative bacteria present in all nutritional supplements, from raw materials to the finished product.

USP <2022> Microbiological Procedures for Absence of Specified Microorganisms-Nutritional and Dietary Supplements: Procedure for determining the absence of specified objectionable organisms. Good manufacturing practices require that objectionable organisms be absent from non-sterile nutritional and dietary products. Objectionable organisms are defined as microorganisms that may cause potential health hazards to the user of the product and would adversely affect the product safety.

USP <2023> Microbiological Attributes of Non-sterile Nutritional and Dietary Supplements: contains information about frequency of microbiological sampling and testing, recommended microbial limits for botanical ingredients and products, and finally, recommended microbial limits for dietary supplement ingredients and products. However, specifications are typically are developed by the manufacturer with guidance from USP <2023>.

USP <1223> Validation of Alternative Microbiological Methods:  Any alternative method must be validated against these UPS methods using the methodology described in USP <1223> including side-by-side testing, determination of the accuracy, specificity, limit of detection, robustness, ruggedness, etc.

Many methods validated for food products, are not necessarily validated or appropriate for dietary supplements. For example, many methods have been written for very specific products such as eggs, meat, milk, nuts, etc. These methods were not written with dietary supplements in mind. And “dietary supplements” encompass such a large scope and variety of products therefore, it is risky to simply assume that a method written for example for eggs will also work for supplements.  Therefore, a method having AOAC certification is not necessarily appropriate for dietary supplements.  AOAC had not certified any microbiological method for dietary supplements, all their methods are certified for food only.

Often, one method will work for one product but not for a different product. Petrifilm methodologies are excellent methodology for many food products. However, Petrifilm should not be used on dietary supplement samples without thorough validation. For instance, samples that are dark in color and many common dietary ingredients might make it difficult to see growth on the Petrifilm. Viscous products such as Psyllium begins to harden before an appropriate spread on a Petrifilm can be obtained.

Product Interference or Matrix Effect

Spirulina, turmeric, Psyllium, honey, Calcium carbonate, dyes, and oils: these are just a few of the many products that the Nutraceutical industry works with, and struggles with. Many botanicals, herbals, enzymes or protein powders create challenges for microbiological testing (Tackling those challenging Nutraceutical Products with Rapid Automated Microbiology Testing!, C. Ockerman 2013). Granules (which can often be mistaken for a bacterial colony), extreme pH, viscous products can all interfere with the plate count methodology.

Microbial Testing of Dietary Supplement

Microbiological testing in the dietary supplement industry consists according to the USP chapters, of monitoring levels of naturally occurring indicator organisms and spoilage organisms, as well as the absence of objectionable organisms (e.g., Salmonella, Staphylococcus aureus, and E. coli) in finished products.

The typical battery of microbiological tests for a dietary supplement includes:

• Total Plate Count

• Yeast and Molds

• Enterobacteriaceae (gram negative bile tolerant bacteria)
• E. coli
• S. aureus

• Salmonella

• Pseudomonas (for liquid products or products with high water activity, or topical/cosmetic products)

How to Test for Microbiology

Many companies outsource the microbiology testing to third party commercial testing labs instead of performing it in house.  Some companies fell that whenever products are sent out for testing quality results cannot be questioned, but time is sacrificed and a premium price is paid for the service. Therefore, companies tend to only bring their microbiological testing in-house when they reach a critical mass such that the cost of sending out is equal to or more than starting up a laboratory.

In house Laboratories can perform using the USP methodology.  In preparing its own media and reagents the lab needs to pay attention to USP <1117> (Good Microbiological Laboratory Practices).  Because in an internal laboratory the quality of the results depends on the quality of the culture media prepared.  This includes accurate weighing of dehydrated components, the use of high quality (USP Purified) water, completely dissolving the dehydrated media or individual ingredients, and the need to control the heating of the media to avoid damaging heat-labile components of the media. The quality control of each batch of the media is a critical concern.

It is important to take production timelines into consideration when determining what methods fit each company individual needs.  A major issue with microbiological testing is the hidden costs in labor and inventory hold time.  The one assay that often keeps a quality control manager up at night is their yeast and mold testing—which takes five days to obtain a result.

Why Automated Rapid Microbiology?

Internalizing the microbiology testing and especially adopting rapid microbiological methods (RMM) can speed up the time to results from 7-10 days to 24-48 hours. The time saved has a direct and REAL impact on many key operational profit drivers.  The Advantages of RMM can include: Greater accuracy, better sensitivity, and increased sample throughput, automated data capturing and allowing easier data handling, and reduced cost for product release.  Rapid methods allow test results to be obtained faster. More importantly, if a product is above a desired microbiological specification, the results are obtained a lot sooner, and corrective action can be taken days before traditional methodology would allow.

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 rapid microbiological methods (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.

The BioLumix Advantage
The BioLumix System is a system that fits a need in the Dietary supplement industry in terms of speed, working with all product matrices, and automatically documenting the results in real-time, thereby reducing the labor requirement for microbiological testing.

The BioLumix system was extensively validated for dietary products and compared to the methodology described in USP <2021> and <2022>.  The validation methodology followed USP <1223> “Validation of Alternative Microbiological Methods”.  This included performance criteria such as: side-by-side comparison to the USP methodology, accuracy and precision, specificity,  limits of detection and quantification, along with ruggedness and robustness, reproducibility of the results, false positivity rate and false negative rate.

A full validation package including Installation Qualification (IQ), Operational qualifications (OQ) and Performance qualification (PQ) is included with the BioLumix system
The BioLumix Advantages include:

  • The only system with all assays on a single platform
  • Real-time communication – early warning of contamination
  • 48-hour Automated Certificate of Analysis
  • Simplified testing with ready-to-use vials
  • Each vial comes with a certificate of analysis, negating the need for QC of the vials
  • Validated for dietary supplement products – IQ, OQ, PQ
  • No product interference
  • 21 CFR Part 11–compliant software
  • Remote-access customer support 24/7/365

SupplySide MarketPlace 2013

May 2013, Exact Dates TBD | Javits Center New York | New York City
www.MarketPlace.SupplySideShow.com
SupplySide Marketplace will be held for the 2nd year at the Javits Center in New York City. This larger, newer hall has much more room for more buyers and global suppliers to network and connect. BioLumix will be exhibiting for the 6th consecutive year. Stay tuned for more details.

Modern Sterile Product Manufacturing – Exploring Best Practices and Seeking New Approaches

April 15 – 17, 2013 | The Peabody Orlando | Orlando, Florida
www.pdaannualmeeting.org
PDA Annual Meetings have become the most widely attended and essential conferences in the pharmaceutical and biopharmaceutical industry for those interested in increasing job knowledge, performance and effectiveness. The 2013 Annual Meeting will continue this trend by offering formal sessions and informal networking opportunities focused on key areas of interest in sterile product manufacturing, biological technologies, and improved process control, as well as a forum to contribute to and influence the advancement of science and regulation.

Supply Expo West & Engredea 2013: Anaheim, CA

March 8th – 10th, 2013 | Anaheim Convention Center | Anaheim, CA
www.expowest.com
Engredea brings together the community of leading suppliers and manufacturers to source new ingredients, packaging, technologies, equipment, and services in the global nutrition industry. Engredea, co-located with Natural Products Expo West, is the only tradeshow that brings together the full food chain of supply to shelf. Engredea cultivates innovation for tomorrow’s best-selling products across food/ beverage, dietary supplement and nutricosmetic categories by offering hundreds of exhibits, formulation demos, networking events and education opportunities for the industry.