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.
Many companies use in house laboratories and perform using USP methodology. In these cases, when it comes to preparing their own media and reagents, the lab needs to pay special attention to USP because 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. However, a major issue with microbiological testing is the hidden costs in labor and inventory hold time.
The BioLumix system simplifies the testing due to the pre-made vials that do not require a technician to run quality control on the vial.
Sample preparation for the USP to BioLumix is very similar, so the transition for most laboratories is very simple. The benefit that is gained is the time it takes to get results and the ease of processing samples.
One example for sample processing is Yeast and Mold, which shows the advantage of the BioLumix system. Both the USP and BioLumix sample preparations start with a 10 gram sample into 90ml of either Butterfields Buffer or Fluid Soybean-Casein Digest Medium (TSB). The sample is then tested for pH to make sure it is the optimal range (6.0-8.0). From this point the BioLumix system shows how much easier and efficient an automated system is over the traditional methodology.
For the BioLumix system, the sample is then added to the vial, the information is added to the system, the sample starts running and 48 hours later, the data is archived and completed.
Now, compare that to the traditional USP methodology. First is the need to melt the agar used to pour the plates, and the time it takes to allow the media to temper down to an appropriate temperature that does not damage any possible organisms in the product. Then you must take the sample and pipette it onto the plate, and then pour the tempered media on the plate. Next, comes swirling the media and sample to evenly distribute it throughout the plate. Finally, then use must allow it to solidify and then place in the incubator for 5-7 days. Once the incubation is complete, read the plate and record the results.
The BioLumix system gives the result in 48 hours and automatically tells the customer if it is above or below the specification level. While the traditional USP methodology needs to wait 5-7 days before results are complete.
Many other assays that use the BioLumix system reduce the time to get results much quicker than USP. For example, total aerobic count which instead of 2-3 days using traditional USP methodology, is less than 24 hours on the BioLumix system. E. coli testing takes three days using USP methodology but only two days using the BioLumix system.
The BioLumix System is a system that fits the needs of the 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.
Join Neogen at booth #175 on March 6– 8, 2015 for Engredea 2015 at the Anaheim Convention Center.
Engredea brings together a community of leading suppliers and manufacturers of new
ingredients, packaging, technologies, equipment, and services in the global nutrition industry. Engredea, co-located with Natural Products Expo West, is the only trade show that brings together the full food chain of supply to shelf.
Neogen, a world leader in food safety, is excited to showcase new solutions to facilitate cGMPs, quality assurance programs and verification systems at Engredea. Neogen will be presenting new products that have been validated specifically for natural products, dietary supplements, and other nutritional products.
The BioLumix System
Allergen control tests and plans
Hygiene monitoring equipment
The BioLumix Rapid Microbiology System delivers significant reduction in time to results, reduced staff involvement, and faster product release. BioLumix can save multiple days versus current testing methods and dramatically impact key profit drivers. The validated BioLumix system allows for easy compliance with cGMP. BioLumix will streamline your microbiological testing saving significant time labor and money. 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 BioLumix Rapid, Automated Microbiologyyou can view microbiology product testing from a position of company strength and competitive advantage! Streamline your microbiological testing, reduce cost, increase efficiency and show rapid return on investment. The BioLumix system is FDA compliant, 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.
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.
AccuPoint Advanced is Neogen’s the newest hygiene monitoring system. It gives users the most complete system, from accurately capturing samples, to generating useful information to drive improvements. Visit Neogen’s booth #125 to hear more about the new system, and see a demonstration to see why the AccuPoint Advance is the right tool for the job.
As the need for rapid microbiological testing in various industries continues to grow, Neogen’s recent acquisition of BioLumix helps provide new resources to an already successful rapid microbiological testing product. Specifically in the nutraceutical, dietary supplement, cosmetic and pharmaceutical markets, the BioLumix system serves customers with a system supported by validation datasets, ready to use microbial tests, and Neogen’s excellent customer service. In fact, the value of the system from the perspective of some of our customer’s can be found in their testimonials and feedback. Along with great customer service, some of the key aspects that customers are able to take advantage of include 48-hour certificate of analysis and ready to use assays.
Upon reviewing both the BioLumix system and Soleris, it is apparent that both of these systems offer advantages over other methods and products. These include:
Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours
Automation and connectivity allows faster product release
Paperless laboratory: centralized test data automatically stored and protected
Ready to use test vials
Excellent customer support
The differences lie in the application and validation information supporting both systems. For example, the BioLumix system has submitted a DMF to help aid companies on technical and regulatory information on approvals for prescription drugs. The BioLumix system has an established protocol for preservative efficacy testing, adhering to USP Chapter <51>. Neogen also has the capability to provide services on the BioLumix system, such as suitability testing, USP Chapter <61>. The BioLumix system comes with uniquely designed validation books for nutraceutical and dietary supplements, cosmetics and toiletry, and for over the counter medication.
Similarly, the Soleris system has been for various food matrices. For
example Soleris has been validated for use in aseptically packed UHT products, dressings and sauces, and many other matrices as supported by the AOAC approvals. Because of the focus over the last few years of Soleris in food matrices, Neogen has developed various tests and applications specifically for food. For example, the 48 hours direct lactic acid vial for dressings and sauces, the orange serum broth vial for low pH and beverage applications, and the alicyclobacillus vial for beverages.
Validation strategies for both systems also varied because of market requirements. For example, in the food industry, companies seeking certain SQF level certifications require an AOAC approval on all methods used. Meaning that food testing validations were done according to the outlines and recommendations provided by AOAC International.
In addition, Neogen’s industry leading customer and technical service are now supported by the microbiological excellence of the staff from BioLumix. Both systems come with packages and programs for installation qualification, operational qualification and performance qualification. Furthermore, both systems have packages available to maintain the system through preventative maintenance programs.
Which system is right for you? It depends on the type of products manufactured, and the requirements. Neogen would be happy to help you understand the advantages of both systems and provide more information that can help you make the correct decision. You can contact Neogen by calling 800-234-5333 or emailing email@example.com.
Raw material screening is an important part of 21 CFR 111. The current aspects of 21 CFR 111 do not put the burden of raw materials on the raw material manufacturer. The burden of the products from a compliance stand point lies within the manufacture of the product, and the brand holder. They do however have to follow 21 CFR 110, food processing cGMPs and are less stringent.
The testing requirements for dietary supplements and nutraceutical companies for raw materials under 21 CFR 111 is in sup part E, 111.75. Sup part E, section 75 states that one test must be completed to verify the identity of the compound before use. Before testing raw materials for microbial content, there are a few important considerations.
Does the process using this raw material undergo a microbial reduction step?
Does the screening cost (including holding time costs), outweigh the possibility of a rejected lot?
Does the manufacture have a long standing record of providing materials within your critical limits?
Are there antimicrobial properties of the ingredient? And will it be diluted when used in the final product formulation?
Setting specifications for raw materials will help determine if microbial testing should be completed before use. For example, if a product contains antimicrobial properties, and is diluted in a final product, the dilution of the anti-microbial properties could allow for microorganisms to grow. In this example, a lower specification could be used to screen out raw materials that would create problems to the final product when the antimicrobial properties are diluted.
Once limits and testing regimes have been determined for raw materials, another critical aspect to consider are the implications on the manufacturing process and the supply chain. If adding new testing points for total aerobic count (TAC), and yeast and mold (TYM), considerable time can be added to the entirety of the process.
When considering the supply chain of raw materials, and the manufacturing process, the total test time for total aerobic count, and total yeast and molds is critical. Adding 5-7 days of testing time on raw materials can be detrimental for manufacturing, and ruin just-in-time inventory practices. The BioLumix system allows for additional microbial testing controls, without the burden of long wait times.
The BioLumix system comes with a validation book, which helps provide users and auditors the needed data to show that the system is compliant and validated. Additionally, the BioLumix system can be validated against USP standards following the USP <1223> requirements.
For additional references, Michael McGuffin, President of the American Herbal Products Association, provided a useful overview of 111 compliance at a recent seminar. NSF provides training resources and support through their Dietary Supplement and Sports Nutrition groups.
A couple of recent incidents have brought Bacillus cereus back into focus. In the UK for example, liquid baby formula contaminated with the bacteria killed one premature baby and was responsible for sickening 14 others in six different hospitals. Then, in China, 139 people become sick after consuming fermented
black beans (douchi) in Yunan. After studies were done on vomit samples and the unprepared douchi, three Bacillus cereus strains were isolated.
Bacillus cereus is an aerobic and facultatively anaerobic, motile, spore-forming gram-positive rod. B. cereus exists in two forms: spores and vegetative cells. Because B. cereus is found in soil, so raw plant foods such as rice, potatoes, peas, beans and spices, are common sources of the organism. The presence of the organismin processed foods results from the contamination of the raw materials and the subsequent resistance of the spores to thermal and other manufacturing processes. During food’s cooling process, spores may germinate, enabling B. cereus to multiply and produce high levels of the emetic toxin cereulide.
After consumption of contaminated foods, B. cereus causes two types of gastroenteritis. One is an emetic syndrome with a relatively short incubation period of 1-6 hours that results in nausea and vomiting. The other is a diarrheal syndrome with an incubation period of 6-24 hours causing watery diarrhea, abdominal cramps, and pain.
This quick onset of symptoms can pose a serious problem for passengers on an
international flight for example, where many people can become sick in a short period of time. While foodborne illness associated with air travel is quite uncommon, foodborne outbreaks have been recorded by the airline industry as a result of improper testing or handling of food. When this does occur, it can have serious implications for passengers and crew members and means quality, safe, in-flight catering must rely on high standards of food preparation and storage; this applies at the airport kitchens (or at subcontractors’ facilities) and on the aircraft.
Bacillus cereus has also been recognized as a cause of potentially fatal systemic infections outside the GI tract, particularly in high-risk patients, such as infants, immune-compromised individuals, and chronically debilitated or elderly patients. These infections include bacteremia, septicemia, meningitis, cerebral abscess, pneumonia, and endocarditis.
The risk of illness after ingestion of vegetative B. cereus cells is influenced by the strain, composition of the food, the liquid nature of the food and the age of the individual. Young children are particularly susceptible and may be more severely affected by a B. cereus contamination resulting in severe complications and even death. Because liquid foods, such as infant formula, are transported faster to the small intestine they are protected from the influence of gastric conditions, providing more opportunity for the survival of the pathogen.
BioLumix B. cereus Vial:
Detecting B. cereus as quickly and easily as possible is of paramount importance when corrective action(s) can minimize public exposure. BioLumix has an assay that detects B. cereus in 24 hours. The B. cereus vial’s sensor detects production of CO2. The disposable vial contains a transparent solid sensor located at the bottom which changes its optical properties whenever CO2 diffuses into it. Only gases can penetrate the sensor; blocking liquids, microorganisms, and particulate matter. Consequently, the optical readings are not masked by the sample. CO2 generated by B. cereus metabolism in the liquid medium placed above the sensor, diffuses into the sensor and interacts with an indicator reagent to provide an indication of the presence of the carbon dioxide. The medium contains growth promoting ingredients and inhibitors to gram-negative and non-Bacillus cereus gram-positive organisms. The method used is very simple; just pipette the diluted sample into the vial and your results can be obtained in 24 hours or less.
Advantages of BioLumix Vials:
Vials can be stored at room temperature
Prefilled ready-to-use vials come with a Certificate of Analysis
Automated same day test results
Vials are available for a variety of tests, each with organism-specific enrichment medium
A single organism can be detected in a vial, if capable of growth in the medium
Liquid culture from a vial can be used to perform further tests
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