The BioLumix system will deliver efficiencies and add profit to your bottom line with labor savings. Shorter sample preparation and automation with real-time communication will allow you to release product faster and give you early warning of contamination.
A Real Technological Difference
The BioLumix System integrates the Instrument, Test Vials and Software with expandability that can be scaled to meet your needs and flexibility to fit any lab's requirements.
Service that is Second to None
Our goal is to provide every customer with high quality products, superior usability and reliable customer service to ensure your success. Our services include:
Easy to Use and Understand
Based upon state-of-the-art knowledge of the microbial metabolic process, the ready-to-use vials are designed to rapidly detect color or fluorescent change as a result of metabolic activity in a liquid medium.
Often one of the first questions we receive about the BioLumix system is “how much does it cost?” While this blog post won’t be able to cover specifics on the costs of the BioLumix system or the individual tests, it will outline some of the considerations and areas for savings as it relates to preservative efficacy testing according to the United States Pharmacopeia <51>. In our example analysis, we are able to reduce the cost of doing PET by nearly 40%.
USP <51> helps show the effectiveness of a preservative, or a preservative system. This testing is done according to the procedures outlined in USP Chapter <51> Antimicrobial Effectiveness Testing. This chapter describes in detail which organisms to use, the appropriate inoculum based on a product, and the necessary log reductions that the preservative system needs to achieve.
Before a side-by-side comparison is done, a validation is required of any alternative method. Using the protocol outlines in USP chapter <1223> Validation of Alternative Microbiological Methods we can see that the BioLumix system meets the following requirements: Specificity, Limit of detection, precision and repeatability, robustness ruggedness, false negative rate, and false positive rate. A more in-depth discussion around USP validations and Neogen’s Validation book can be found here: http://www.mybiolumix.com/biolumix-validation-book-for-dietary-supplements/
An overview of USP <51> can be found here: http://www.mybiolumix.com/guidelines-simplified-automated-microbiology-testing-system. The two methods can be broken down into two approaches; materials and labor. Comparing the materials is straight forward. Reviewing the protocol shows that each time point requires an analysis of 3 bacteria, 1 yeast and 1 mold. Each organism requires a neutralization, and multiple dilutions when using traditional microbiology. Each organism also requires a total of 5 plates! Each plate requires a dilution blank, as well as a pipette tip.
There are several points of parity between the USP <51> traditional plate count methodology and the BioLumix system. First, the BioLumix system also requires 3 bacteria, 1 yeast, and 1 mold to comply with USP <51>. Each method will also test the preservative system at multiple time points over the course of 28 days. However, the BioLumix system is able to provide a microbiological count without 5 plates, without multiple dilution blanks, and without multiple pipette tips. The picture below helps illustrate how a nearly 40% reduction is achieved with Neogen’s BioLumix system methodology.
The second comparison is to determine the amount of labor required to run a USP <51> protocol with traditional methods. With the automation of the BioLumix system eliminates plate reading. The vials in the BioLumix system are automatically read, and the result is recorded in the database. Report writing is simplified with the Certificate of Analysis generated automatically. Time study estimates performed by Neogen estimate the labor reduction using BioLumix for PET is greater than 60%!
Neogen invites you to visit them at booth #674 at the American Society of Microbiology (ASM) General Meeting coming up next month from May 30 — June 2.
Held at the Ernest North Morial Convention Center in New Orleans, ASM2015 is
one of the largest microbiology conferences and Neogen will be exhibiting their leading microbiological testing products.
Neogen has a suite of microbiological testing products, including dehydrated culture media – Acumedia. Neogen also has pathogen detection methodologies for food matrices. These tests are often used in conjunction with Neogen’s line of Acumedia product. More information on Neogen’s Food Safety division and foodborne pathogen detection systems can be found here.
In addition to the traditional and pathogen detection methodologies, Noegen also has the BioLumix system. The BioLumix system helps customers rapidly test finished goods, raw materials, or in-process commodities for bacteria, yeasts and molds, and other objectionable organisms. One of the key features of the BioLumix system is the 48 hour certificate of analysis. Dietary supplement and nutraceutical companies are able to maintain compliance with certain aspects of 21 CFR part 111 using the BioLumix system. Also, the validation book helps our customers easily survive audits and come as a package deal with the BioLumix system from Neogen.
If you aren’t familiar with the type of information that’s presented at ASM, the agenda can be found at: http://gm.asm.org/. The opening session of the meeting provides a scope of the 2014 program, which can be viewed in its entirety here.
To help solidify your knowledge and keep you up-to-date in the evolving world of microbiology, there are also several educational sessions at ASM2015. These included everything from overviews on pathogenic organisms, to detection and characterization developments. Additional interesting topics include transmission of pathogens, evolution of microbes, and even natural food trends as they relate to microbiology. Posters and sessions related to food microbiology can be found at: ASM2015.
Whether you are a manufacture, a researcher or a student, Neogen would love for you to stop by their booth to talk more about microbiology and discuss the food safety solutions we have available. ASM2015 is shaping up to be another great conference and Neogen is looking forward to hearing what exciting things you’re learning while you’re there.
The implementation of cGMP for all manufacturers (large and small) of dietary supplements andNutraceutical productsmeans that all manufacturers must test their products for microbiology quality assurance and generate a Certificate of Analysis for each batch. Products must be tested in accordance with the methods described in USP <2021> and <2022>. This includes testing for Total Aerobic Microbial Count, Total Combined Yeast and Mold, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organisms such as Salmonella, E. coli, and sometimes S. aureus). To do these tests companies either send product samples to contract laboratories for microbiological testing or test them internally.
Internal testing of products for microbiology gives the manufacturer much more control over the operation, but some manufacturers are hesitant to bring the microbiology testing in-house for fear of the complexity of testing or the need for trained microbiologist(s). Also daunting is the need for a full validation package which is required for any method that deviates from the USP methodology. Here’s the good news – BioLumix offers a solution that gives faster time to results, quicker product release, cost effective operation, and strengthens key profit drivers. This is all achieved on a single platform that is easy to use, validated to USP requirements, and doesn’t require additional skilled personnel.
What is the Complete BioLumix Experience? It’s having, from initial contact to the completion of the installation and beyond, our commitment to providing unparalleled support and total customer satisfaction.
In 2006, Ruth & Gideon Eden established BioLumix, Inc. Today, because of their extensive backgrounds in science and technology combined with customer-oriented sales and support staff, we have raised the simplification, automation and speed of microbiology testing to a new level.
Needs Assessment - Whether you contact us direct or through our website you can count on our sales team to respond quickly. The focus is on your needs and goals. Our BioLumix Technology Presentation provides an in depth look into how and why our system will work for you. In addition, we can quickly and easily show you the value and the ROI the system will bring to your company.
Expertise – Knowing how the BioLumix system will work withyoursamples gives you peace of mind. That’s why we test samples – YOUR samples – for you at our laboratory in Ann Arbor, MI. We do this for you at no cost and at no obligation! Once completed, expect a comprehensive report from one of our expert microbiologists. That same microbiologist spends two and a half days on-site for training and installation of the system.
Validation – If you are concerned about validation, here is more good news. We provide complete SOPs along with a customizedValidation book which includes Installation Qualification (IQ), Operations Qualification (OQ) and Performance Qualification (PQ).
Simplicity and Ease-of-Use- The easy to master BioLumix system offers a new level of productivity. Sample preparation takes less than 2 minutes; just add the sample to the diluent and mix. Pipette the appropriate amount into the vial and place it into the instrument and record the sample and assay information into the computer. The rest is totally automated. The Certificates of Analysis will automatically be generated in as little as 24-48 hours!
Support – Our jobs center on satisfying our customers and providing unparalleled support. At BioLumix you receive 24/7 support plus a microbiologist dedicated to service you and answer your questions. What happens if you encounter a problem? Troubleshooting can be done via the internet and in most cases problems are resolved. If needed we provide a loaner instrument while your instrument is being fixed to minimize downtime. Our website provides instant access to information and resources about our technology, instruments, assays, and more. It’s also mobile-enabled to format to your handheld devices. Links to social media, white papers, blogs, videos, and other informative contact information puts everything you need at your fingertips.
Continuous Product Improvement – At BioLumix we have an ongoing commitment to evolving and adding to our platform. One way this is achieved is through our partnership with our customers. Customer feedback, along with a desire to increase the breadth and depth of our offerings, helps us to make improvements to our media and our assays. We have recently introduced two new assays – Listeria and Bacillus cereus.
With a simplified method such as the BioLumix System we can provide a simple cost effective method to test products for microbiology.
Join Neogen at booth #528 from April 7th – 9th for Ingredient Marketplace 2015 at the Orlando World Center Marriott.
Ingredient Marketplace brings together experts in the community of nutrition,
health, food and beauty products and provides opportunities for networking, purchasing and business development. Additional insights from educational programs include global insights, and categorical trends.
Neogen is a world leader in food safety, and excited to showcase new solutions to facilitate cGMPs, quality assurance programs, and verification systems at Ingredient Marketplace. Neogen will be presenting new, key products that have been validated specifically for nutritional, health food, beauty and other related products and include the BioLumix System, allergen control tests and plans, as well as hygiene monitoring equipment.
The BioLumix Rapid Microbiology System saves time, reduces staff involvement, and leads to faster product release. The validated BioLumix system also allows for easy compliance with cGMP, streamlining your microbiological testing and once again saving you time, labor and money. BioLumix delivers shorter sample preparation, automated real-time communication, fast product release and early warning of contamination. The system is also paperless and efficient, saving on disposables, time and space, while eliminating product interference, and delivering accurate results.
The BioLumix system is also fully automated, validated against USP
methodology and supports 21 CFR Part 11 Compliant. The system delivers complete microbiology testing results within 24-48 hours, allowing for faster product release time and shorter sample prep time.
In addition, Neogen’s allergen testing solutions help companies put together best practices for allergen control. Neogen’s industry supported Supplier verification document starts with raw materials. Using testing and best practices, companies can have confidence that ingredients, sanitation teams and their products all comply with allergen label claims.
Please also visit Neogen at booth #528 to hear more about AccuPoint Advanced, Neogen’s newest and most complete hygiene monitoring system and to see a demonstration as to why the AccuPoint Advance is the right tool for the job.
What was once an obscure foreign dairy product, Greek yogurt has exploded into a billion dollar business, and it is still growing! Greek yogurt sales are 50% higher than at this time last year and represent more than one-third of all yogurt sold in the U.S. By comparison, in 2007 Greek yogurt accounted for only 1% of the total yogurt market.
As with regular yogurt, Greek yogurt is made from fermented milk that is soured and thickened by adding specific lactic acid-producing cultures. However, Greek yogurt is strained more times than traditional yogurt to remove more whey. As a result, Greek yogurt is thicker and has more protein than regular yogurt. The basic cultures or probiotics used to make yogurt are Lactobacillus bulgaricus and Streptococcus thermophilus and many additional probiotic organisms are often added which include Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium species, all of which may help to maintain the balance of bacteria needed to boost the immune system and promote a healthy digestive tract. According to the Obesity Action Coalition, yogurt is the number 1 natural source of probiotics eaten by Americans. The live microorganisms in Greek yogurt can help improve your digestive system, help your body absorb nutrients, and improve your health. Greek yogurt may also help ease gastrointestinal conditions like constipation, inflammatory bowel disease, lactose intolerance, and diarrhea.
It is this overabundance of helpful bacteria that can interfere with the detection of yeast and molds in Greek yogurt.
Yeast and Mold Testing in Yogurt
Undesirable microorganisms constitute the primary hazard to safety, quality, and wholesomeness of milk and dairy foods. Yogurt is susceptible to microbial contamination, especially by fungi which grow and reproduce in acidic environments containing oxygen. In a study by Montagna et.al. (1998), a variety of differently manufactured yogurts from a variety of manufactures tested positive for fungi, of which 75% of the 7.2% positives were yeasts and 25% were molds with counts between 200 and >106 cfu/ml. Yogurts contaminated by fungi can have modified organoleptic characteristics. The most common molds found were Aspergillus and Penicillium and the most common yeast belonged to Candida, Cryptococcus, Rhodotorula species.
Traditional methods are slow, tedious, labor intensive, and often not suitable for assessing the quality and shelf-life of perishable dairy products. The emphasis on the programs based on HACCP (Hazard Analysis and Critical Control Points) for total quality management in the dairy industry and increased demand for microbiological surveillance of products, process, and environment, have led to increased interest in rapid methods and automation in microbiology. In the past few years rapid automated methods such as BioLumix and Soleris have been adopted to speed up time to results and automate and simplify the microbiologist tasks.
The BioLumix technology can make the microbiological testing simpler, faster, and automated, saving time, labor and money.
The BioLumix test method for detection of yeast & molds involves a direct addition of the sample into ready to use vials and automated monitoring of the samples in the instrument. This simple method saves labor and disposables. The yeast & mold assay is completed in 48 hours as compared to the 5 days required for the standard assay.
The ready–to-use vial comes with media that is pre-adjusted for pH, such that after the addition of the sample the appropriate pH for the growth of the microorganisms is attained. BioLumix has developed such a media that is custom made with a higher pH to accommodate the low pH of yogurt while still maintaining the capability to test as much as 1.0 gram of product directly in the vials. The addition of the supplement to the vial results in the elimination of background growth from lactic bacteria resulting in flat curves.
The initial work with yogurts containing high levels of probiotics showed that the probiotics caused false detection in the instrument due to the CO2 production by the Probiotic bacteria. As shown in the picture below, the addition of a supplement containing inhibitors to prevented the growth of the probiotics in the vials and resulted in a clear detection of fungi, when present, and a clean flat curve when organisms are not present.
This newly developed assay has a high sensitivity, being able to detect a few yeast or molds in a gram of sample, is easy to perform (less than one minute hands on time), and result in quick time to results. Many different flavors of various brands of yogurt were tested and none created a false positive result. Store bought contaminated yogurt detected in the system as did all the samples inoculated with low levels of yeast or mold.
The BioLumix System is designed to accelerate product release with a simplified, automated approach. The system 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.
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.
If you are interested in participating a field trial with Neogen’s new test, please contact firstname.lastname@example.org
Reference: M.T. Montagna, R. Erroi, S. Sanapo, G. Caggiano, F. Bagordo, A. De Donno, Food products and fungal contamination. Note I. Preliminary investigation in commercial yoghurt. Journal of Preventative Medicine and Hygiene 39: 68-70. 1998
Web-related information about microbiology is plentiful. There are a variety of social media resources available to a microbiologist, from scientific information, to opportunities to benchmark practices, obtain training opportunities, and to keep current with the latest news and developments in virtually any area of interest .All it takes is a little research and an open mind.
Available Information Sources
News and Company Sites
In recent years, there have been more and more websites dedicated to microbiology on the Internet. There are also sites dedicated to providing news, as well as, websites dedicated to providing microbiology supplies.
A few examples of major sites containing information and news related specifically to microbiology are:
The BioLumix website is updated frequently with information about the technology, new development and current events. Click on the icon to connect to BioLumix website
Blogs can be viewed as online journals that are created by individuals, groups, or companies. Blogs has exploded in recent years due to the ease of blogging and the multitude of hosting services available. The growth of the blogosphere has become so pervasive that some question the viability of print magazines.
Many blogs, of interest to a microbiologist, are published frequently and may well serve to replace printed publications in terms of timely information. Below are a few examples:
BioLumix posts bi-weekly blogs on a variety of topics in rapid microbiology, about regulations, and about the BioLumix technology. To stay current on our new developments click on the icon to connect to BioLumix blog.
E Mail discussion Groups
Email discussion groups are created to encourage discussion around a unifying topic. Users subscribe to the group. The basic mechanism is to have a central Email address to which all mails are sent. If a subscriber has a question or comment it is sent by Email to that address. The email is then resent to all of the participants. If one (or more) participant wishes to comment on the Email, that reply is then sent to the central address for redistribution and the cycle repeats.
The Email discussion group is the oldest form of social media participation. There are two Email discussion groups of use to the microbiologist – the PMFList and the PSDGList. Both focus on Pharmaceutical production and validation.
LinkedIn is a business-oriented social network and it provides a variety of opportunities to connect with other microbiologists and join discussions. LinkedIn also supports the formation of interest groups, and many people use the groups on LinkedIn as a kind of think tank or open brainstorming session. Others use it to disseminate information. It is an essential business resource of information, LinkedIn can help you stay up-to-date with industry trends and share information with others who do similar work to you. Many companies have a company page on LinkedIn.
BioLumix has a company page on LinkedIn that contains relevant information about the products as well as corporate news. To view our LinkedIn page click on the icon. BioLumix Linked In page:
BioLumix also sponsors the discussion group Rapid Microbiology Testing and Methods. To join the group and read the content of this informative group click on the icon. Rapid Microbiology Testing and Methods
Twitter is a messaging service that allows users to post short (140 character) “Tweets” to their followers. Its main use is not in science, but it can offer a good way to rapidly disseminate information. Many Companies and organizations are using this service to get information out quickly and to direct people to web-based information sources. The very brevity of the tweet format can encourage concise expression of ideas and concepts.
To view the BioLumix Twitter page click on the icon.
Google Plus was established in the beginning of 2013 and is currently the second largest social network in the world. It was launched by Google, in order to evolve the way we relate to one another, and how we communicate with the world. At the moment its presence in the microbiology world is limited, but with the Google power behind it is expected to be a major source of information in the near future. Some companies have Google+ pages.
YouTube is a video sharing service. Video provides an excellent opportunity to explain and teach scientific concepts. In the current impatient, busy world, many people would prefer to watch a video instead of trying to digest massive pieces of written information. Since more consumers are spending time online instead of watching TV, the popularity of watching videos online is growing exponentially.
This survey was conducted online, with a group that is part of an internet email group. It must therefore be assumed that the respondents are more technologically sophisticated than is the norm, and had familiarity with social media on its side.
The survey looked at two main questions – What social media are being used and what is it used for?
As shown in the figure, LinkedIn was the most popular social media used by microbiologists, followed by Facebook. The main reason for using the social media was for personal interest, followed by Benchmarking. This survey also shows that once a technology matures (for example the PMFList and the PSDGList Email discussion groups) participation becomes enthusiastic.
The internet and social media offer a wealth of information and capabilities to the microbiologist; it seems as if more microbiologists can take advantage of the opportunities presented. BioLumix participates in many of the forms of social media and offers a wealth of information to microbiologists
Manufacturers of Nutraceutical, Pharmaceuticals, Cosmetics, Dairy, and other products are often faced with the challenge of putting their products in the hands of consumers as quickly and efficiently as possible, while at the same time ensuring the quality and safety of their products. Many of these companies rely on the services of third party laboratories or contract packaging companies to provide timely, accurate microbiology testing of their products and their ingredients. As a result, organizations who provide these types of services may wish to update their labs with Rapid Microbiology Method (RMM) equipment. By adding the BioLumix RMM to their laboratories, lab service providers can significantly reduce the amount of time it takes to provide their customers the quality results they need to move forward with their products.
Internalizing microbiology testing: offering speed and automation
WePackItAll®(WPIA) is a leading contract packaging and service company, combining their customers’ products with their packaging technology and resources to provide customized and affordable solutions.
WPIA are experts in all types of packaging, including: Packets, Gummies, Multi-Packs, Tubes, Stick-Packs, Blisters, Powders, Liquids, Tablets, High-Speed Bottling and more.
“WPIA is honored to be celebrating our 40th year in business, serving the dietary supplement, nutrition, food and health/beauty industries, and we are so thankful for the many people and business partners that have contributed to our success over the years. I have the great pleasure of working with an amazing group of professionals every day and without a doubt, they are the biggest reason WPIA has been so successful over the years.” says Dave Hoover, COO.
In the beginning of 2013 WPIA launched its in?house laboratory, offering microbiological testing services to meet testing requirements and serve the needs of their partners. WPIA chose the validated BioLumix system for their microbiological testing.
We recently interviewed Suren Zatikyan, Quality Assurance Lab Analyst, and Kristopher Flores, Quality Manager.
BIOLUMIX: Why did you decide to add the BioLumix system to your lab?
SUREN: The reason we decided to get this system is that it helps us provide our customers with the best service. Because we are a contract packaging company, we need a finished product testing schedule and quick microbiology results that will prove that we have a clean operating environment in our facility and ensure product safety when the product reaches the consumer. That was our primary goal when looking at microbiology instruments.
BIOLUMIX: What were some of the things that impressed you the most about the BioLumix system?
SUREN: When we found out about BioLumix, we discovered it gave us the opportunity to generate results in a very short period of time. In addition, validation studies that were performed by BioLumix, and later on by us, proved that the system itself is compatible with all the standard methods used by USP and other standard methods developed for microbiology labs. We use the BioLumix system to perform some of our environmental testing and monitoring programs, which is very helpful to us.
BIOLUMIX: What has been your experience while working with BioLumix?
SUREN: We were very pleased with the explanation given to us on how the system works, both in terms of capabilities and which tests can be performed. The tests available were the most important assays that we needed such as Salmonella, E. coli, Staph, Yeast & Mold, and Total Aerobic Count. These are tests used on a daily basis. Jason Kircos, a BioLumix microbiologist, was very helpful during the initial 2 1/2 days of training and later on – whenever we needed any information regarding specification values and the use of the software. We had an issue with the computer hard drive, and the technical team was very helpful. Not only did they provide good technical support, but they also sent us brand new replacement computer.
BIOLUMIX: What else would you like to add?
SUREN: We occasionally have some false positive results, due to the sample we are working with, such as samples with high counts because of their botanical nature. Some organisms can be closely related to what we test for. We have our own protocols in place when we see positives and have confirmation tests. We can also use third party labs for identification, as needed. There haven’t been any real issues with the system that we were not able to resolve quickly. There’s never been any major issue which caused us to stop processing and troubleshoot because the system was unreliable.
BIOLUMIX: Were there any marketing strategies for promoting your services with the BioLumix system?
Absolutely. Because BioLumix is more or less an all-in-one package, and given the timeframe it takes to package a product, we really do not have to increase lead times for micro testing. That is definitely a selling point. We placed some information about BioLumix on our website, and also created brochures to promote rapid microbiology in conjunction with some of the other quality systems at WPIA. This is a value-add for our customers.
BIOLUMIX: Did you see any measurable increase in your overall business?
KRISTOPHER: While it is difficult to quantify the impact in that manner, it certainly plays a part in our overall offering to our customers and with our compliance requirements. I deal with all of the customer audits and having finished-product testing capabilities as it relates to microbiology is a selling point. To measure it would be a little tougher to do.
SUREN: Whenever you can add into the conversation that we can perform these tests, it’s a selling point.
KRISTOPHER: Our larger customers require it as part of their day-to-day release process. If the BioLumix system wasn’t in place, it would be tougher to support their needs. In some instances, based on our testing and our customers’ testing, we’ve been able to validate our processes in-house and eliminate third party validation. That makes an impact on the bigger picture for our customers.
SUREN: Sometimes our customers ask if specific counts (CFU) can be generated whenever specifications are given. However, once we explain the method used most of them are satisfied that BioLumix is not a number-specific CFU “count.” We create the specification based on specific values and if the test result is below spec then it passes. If it’s above, then it fails.
BIOLUMIX: Audits – how has the BioLumix system held up under scrutiny during any audits you may have had?
KRISTOPHER: It has certainly been under scrutiny, but the validation package that was prepared at the start definitely goes a long way and satisfies any curiosity when it relates to our customers. We have also had the local California Food & Drug branch here a few times and they checked the system,finding no inconsistencies.
SUREN: The Validation Book is very thoroughly prepared. IQ, OQ, PQ validations, the prior testing by BioLumix, and our own validation shows equivalence with the USP methodology. Everything was very well done and documented.
KRISTOPHER: When I get larger more experienced customers that come to WPIA with very developed systems and very experienced personnel, they take a look and they are thoroughly impressed. In some instances there are some questions, but they’re resolved on the spot.
BIOLUMIX: Would you say your customers are satisfied?
KRISTOPHER: Absolutely. Continuously, our customers tend to move more toward this type of testing compared to what they have been accustomed to in the past. The reductionin time to get results with this system makes the difference.
SUREN: In general, I would say we are quite satisfied with the BioLumix system. The duration of the tests are very short compared to other methods. We are capable of delivering products that are safe and we have peace of mind when we perform our tests. Overall, we have a very successful operation and a cost-efficient system when compared to other options.
Kristopher Flores has been the Quality Manager at WePackItAll since 2012. Prior to that, he was with various other contract manufacturing facilities in aerospace and nutraceutical. Kristopher has extensive knowledge in Quality Assurance, Regulatory Affairs, and Project Management.
Suren Zatikyan has been a Quality Assurance Analyst at WePackItAll since 2012. Graduated from Cal. State University of Northridge (CSUN) with B.A. in Biology. At CSUN was part of undergraduate cancer research program. Prior to WePackItAll, worked in Michelson Laboratories.
BioLumix has developed a Listeria vial that helps detect Listeria in environmental swabs. The Listeria vial capitalizes on the ability of Listeria to hydrolyze esculin, which in the presence of ferric ions, results in the yellow broth turning black and a reduction of the absorbance. This is due to the complexation of the ferric iron with esculetin (6,7-dihydroxycoumarin), the product of esculin cleavage by ?-D-glucosidase, resulting in a black precipitate. Examples of Listeria vials containing the presence and absence of Listeria is shown in Figure 1.
An environmental swab is broken off into a tube containing 5 ml of sterile preenrichment broth. The tube is incubated for 8-24 hours at 35ºC and then 1 ml is added to the Listeria vial as shown in Figure 2. The vial is inserted into the instrument and incubated at 35°C for 12-28 hours.
BioLumix has tested a variety of product swabs using the Listeria assay. All products were tested both un-inoculated and inoculated. The BioLumix system can detect Listeria without interference from the products, which can be more difficult on traditional plating methods. 81 samples were analyzed for Listeria at a specified level of absent in swab of product after enrichment in pre-enrichment broth for 24 hours at 35ºC. 3 samples were above specified level by the BioLumix method but identified as non-Listeria organisms by plate methodology. A Listeria detection obtained with the BioLumix system can be further verified using a simple and quick Rapid Listeria Immunostrip Test. There was 100% agreement between the BioLumix system and plate methodology when product swabs contained Listeria.
The assay has been validated for inclusivity with 11 Listeria strains and exclusivity against a variety of Gram-positive and Gram-negative bacteria, including Staphylococcus, Bacillus, Micrococcus, Salmonella, E. coli, Pseudomonas, etc.
The BioLumix platform allows for all of your microbiology needs to be met with one automated system. Total Aerobic Count, Yeast and Molds, Enterobacteriaceae, and the objectionable organisms (Salmonella, E. coli, Staphylococcus, and Pseudomonas), as well as, environmental testing can all be done with the BioLumix system. The system is fully automated including archiving of data, data maintenance and report generation, and it can be used to create a paperless laboratory. The system is unaffected by product interference and delivers accurate results. The assays are simpler to perform than the standard method saving time, labor, and money.
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.
The validated BioLumix System for Simplified, Rapid, Automated Microbiology Testing
BioLumix was established in 2006 and has developed a novel, patented system for microbiological testing of nutraceutical, food, meat, dairy, beverage, cosmetics, toiletry, and pharmaceutical products.
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 offer individualized customer and industry specific validation packages with IQ, OQ, and PQ.
BioLumix allows for easy compliance with cGMP, will streamline your microbiological testing saving significant time labor and money, reducing cost, increasing efficiencies and showing a rapid return on investment. BioLumix can save multiple days versus current testing methods and dramatically impact key profit drivers. BioLumix delivers shorter sample preparation, automated real-time communication, fast product release and early warning of contamination. It is paperless and efficient, saving on disposables, time and space. The system eliminates product interference, delivering accurate results.
"With over 500 systems in the field, it was gratifying to learn that all our customers said that they would recommend the BioLumix system to their vendors, suppliers and customers! "- Ruth Eden, President, BioLumix
The BioLumix System Drives Profit Ability!
With BioLumix Rapid, Automated Microbiology you can view microbiology product testing from a position of company strength and competitive advantage! The BioLumix system is fully automated, validated against USP methodology and 21 CFR Part 11 Compliant. The system delivers complete microbiology testing results within 24-48 hours, allowing for faster product release time, shorter sample prep time – saving time, money and other resources.
The BioLumix System Advantage:
Single platform testing for all assays: Total aerobic count, yeast and molds, coliforms, Enterobacteriaceae, E. coli, P. aeruginosa, S. aureus, Salmonella, Listeria, Lactic acid bacteria Probiotic, etc.
Real-time communication – early warning of contamination
Automated Certificate of Analysis in 48 hours
No product interference with ready-to-use vials with organism specific enrichment medium
Stackable compact instruments take up little bench-top space
Technical service available 24/7
Ready-to-use assay vials are easy to use
Vial structure eliminate product interference
Capable of performing: Microbial limits, Suitability testing, and Preservative efficacy testing