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.
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
To those people who still honor the tradition of sending out hard copy holiday cards, it has become quite popular for families to include a “year in review update,” which updates children’s ages, significant family events and, for those that are retired, travel destinations which have been checked off the bucket list. Electronically, this is our company update and we’ll send out the electronic holiday cards later this month.
As the year comes to a close and we review input from our customers, our market data indicates that in test method evaluation our customers are looking for higher specificity, faster time to results, and a reasonable cost-per test. They also want flexibility so that the testing platform can adapt to a number of matrices. Other factors include ease of use, robustness, and a test that is approved or can be approved. These factors above must be compelling enough for a company to switch from their existing method and adopt new technology, and it’s not just the QC or QA staff who are in the evaluation loop.
I recently went on a sales call to a company which was evaluating one of our rapid micro systems for the detection of spoilage organisms, and the conversation between the QA manager and the plant manager was enlightening. While the test would involve more work and cost for the QA department, the direct benefit would be realized for the plant manager since the product could be shipped with a much shorter quarantine period, resulting in increased throughput, and significant cost saving by compressing the sales cycle. Summary: Cost for QA, benefit for Operations.
That being said, automated rapid detection of microorganisms is a proven process which meets the customer criteria on several levels. It is sensitive and rapid, it can be used on almost all matrices, it involves less touch-time, takes up less space than plating or film methods, and offers a good value on a cost-per test basis. When one considers that it is essentially a “load and leave” test when interfaced to a LIMS system, the benefits are clear.
Suren Zatikyan from Wepackitall commented “When we discovered the BioLumix system, we found 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 confirmed by us, proved that the system is compatible with 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.”
Kristopher Flores from Wepackitall added “If the BioLumix system wasn’t in place, it would be tougher to support our needs for testing and throughput. 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 saves time, money, and makes an impact on the big picture for our customers.”
Neogen now offers two platforms for rapid micro detection of spoilage organisms, the BioLumix System and the Soleris System. The BioLumix system is geared toward applications which follow USP protocols including dietary supplements, cosmetics and toiletry, while the Soleris System facilitates testing in food matrices requiring AOAC approved methods.
With hundreds of BioLumix and Soleris systems in use, Neogen is the clear leader in rapid microbiology testing in dietary supplements and nutraceutical products and very strong in many market segments in the food industry with Soleris AOAC approved tests. From initial contact to the completion of the installation and beyond, our commitment is to provide unparalleled support and total customer satisfaction.
Other advantages include:
you can count on our sales teams to respond quickly, with the focus on your needs and goals. In addition, we can quickly and easily show you the value and the ROI.
• Expertise– Knowing how the BioLumix or Soleris systems will work withyourproducts gives you peace of mind. That’s why we test samples – your samples – for you. • Compliance validation for BioLumix systems – If you are concerned about validation, here is more good news. We provide complete SOPs along with a customized validation book which includes Installation Qualification (IQ), Operations Qualification (OQ) and Performance Qualification (PQ).
• Simplicity and Ease-of-Use – These easy to master systems offers a new level of productivity. Sample preparation takes less than 2 minutes. The BioLumix System offers certificate of analysis generation in as little as 24-48 hours.• Support – We are committed to satisfying our customers and providing unparalleled support.
The future looks bright for Neogen and the field of rapid microbiology as we continue our ongoing commitment to the evolution to our BioLumix and Soleris platforms based on customer feedback and technology gains. That being said, I would like to take this opportunity to express my appreciation to all of our valued customers with whom we have grown significantly with through the years. With your support will continue to evolve and offer you even more valuable products.
Today’s microbiology laboratories can generate an extensive amount of data across a variety of technologies. Labs are tasked with providing test results and information that is vital to the success of the organization and the safety of its products. Of course, businesses and consumers demand efficiency – the goal is not only to provide safe products, but to provide them as quickly as possible. As labs are updated and become more modern, better methods of data management and record keeping may be necessary in order to maintain or improve efficiency. Luckily, there is a means to achieve this: Laboratory Information Management Systems, or LIMS. 
LIMS are software-based information systems that allows labs to track and share data within their environment. There are numerous LIMS software applications, both open-source and proprietary. But all have the same general goal – to help streamline data management to improve efficiency while reducing overhead costs. LIMS can provide significant time savings for all people involved in a project by improving data access. 
Example diagram showing the concept behind a Laboratory Information Management System and how data & information can be shared within a laboratory environment.
There are many advantages that the incorporation of a Laboratory Information Management System has over a more manual, traditional laboratory. Some of these include improved efficiency, the ability to go paperless, cost reduction, and compliance. Keep in mind, there are quite a few options when it comes to implementing a LIMS system, and whether it was initially an open-source application or a purchased program, a great deal of customization is usually implemented. So when we talk about advantages, some may be more often utilized than others. But any of these features can be of great benefit, depending on the wants and needs of the individual lab.
Improved efficiency is easily recognized when you eliminate the potential for errors from manual data entry. The greater the amount of samples being processed and the total workload, the greater the chance for an error. On the other hand, LIMS streamlines data entry by automating the process. This results in less downtime, faster access to data, and the ability for the LIMS to grow with the increasing needs of the lab.
Some LIMS programs will authorize users to either modify existing reports or create new ones. Also, web-based applications can interface with the LIMS so users don’t need to work directly with the LIMS itself but rather can work with just the reporting modules that in turn query the database  . QC Management can use LIMS for scheduling and Certificates of Analysis. Another great ‘paperless’ feature of LIMS is the ability of some programs to hold all pricing information for tests, which allows invoices to be produced for online access or as PDF documents  . There are many examples of projects for implementing a paperless lab and how they benefited their labs, and one example showed a 30-40% gain in resources as a result of going paperless  .
When it comes to management at an executive level, the proof is in the bottom line. Successful businesses rely on effective cost management. Total costs of operations come in many forms, including labor, resources, downtime, time-to-market, and more. LIMS can impact many of these costs of doing business. For example, one laboratory that implemented a LIMS system reduced its capital investment by 50%, while productivity rose at multiple laboratories  . Another lab saw a 50% increase in throughput two years after implementing their LIMS  . When you consider the time savings, efficiency, and the resulting improvements in time-to-market, LIMS can significantly contribute to overall improvements in cost management.
Product safety continues to be scrutinized in every market – including Food & Beverage, Nutraceutical, Cosmetics, and Pharmaceuticals. Regulatory requirements are implemented to help reduce the risk of contamination, and different products and ingredients require different requirements. This makes LIMS very essential. LIMS can assist in real-time monitoring and Quality Control. Workflows can be managed, samples logged, and tests can be checked against protocols and procedures to ensure compliance. Out-of-spec samples can be reported automatically and flagged. Reports can be automatically generated, and access to this information can be quickly gained by QC. The overall increase in a structured approach via LIMS ensures compliance as business grows and throughput needs increase.
Neogen Corporation provides Rapid Microbiology Method (RMM) platforms such as BioLumix and Soleris. Both systems can interface and exist within a LIMS environment. For more information, visit http://www.mybiolumix.com or go to www.neogen.com.
The BioLumix system provides a single platform for all microbiology assays available for that system, allowing a large variety of tests without the need of additional equipment. And its versatile – the modular design allows it to grow to meet throughput needs. Results of tests for assays such as Total Aerobic Count, Yeast & Mold, Salmonella, and many more can be obtained within 24-48 hours. Tests are be monitored in real time, and a Certificate of Analysis is automatically generated. The system validates to USP <51>, <61>, <62>, <2021>, <2022>, and <2023>  . In addition, Environmental Monitoring and Water Testing can be performed on the same platform.
Other advantages of the BioLumix System:
• Fully automated, easy to use. • Faster sample preparation • Faster turnaround time
• Fully Validated - the system comes complete with IQ, OQ, PQ and all SOP documentation
• Outstanding support
As mentioned before, there are too many LIMS vendors to mention in this document. Some applications will be better suited than others for your specific needs. http://www.Limswiki.org has an extensive list of vendors that provide LIMS systems, and they even break out the vendors by industry. So if you are looking for something more suited for Cosmetics, or for Food & Beverage, you can find those subcategories within that site. It’s not the end-all be-all of resources, but it might be a good place to start.
Routine microbiological testing carried out by the Nutraceutical,
dietary supplements, cosmetics and toiletry manufacturing industries is determined by regulatory requirements. This applies not only to what should be tested and when, but also to the methods that should be used. Whether the final product is sterile or non-sterile, the bioburden exists from the raw materials, throughout the process and/or within the product’s environment (e.g. water) to the final product. A critical review of the overall microbiological process will determine whether the final product will meet its acceptance criteria. In addition, any “objectionable” or “specified” microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.
Whether you are testing a raw material, an in-process sample, final product, or the environment, you should be aware of the critical role that microorganisms play throughout the process. You should also be familiar with the various microbiological related documents needed to determine whether the SOPs, validations, and regulatory body documents are being maintained to assure the control required to permit the final product to enter the marketplace as safe.
The Unites States Pharmacopeia (USP) is a non-governmental organization. Their documents are recognized as an official compendia book of methods and standards for Pharmaceutical, nutraceutical, dietary supplements, cosmetics, and toiletries. The USP offers a variety of documents such as monographs (published standards) and general chapters. General chapters with numbers 1000 are considered informational chapters.
Nutritional and Dietary Supplement USP Chapters
Since June 25, 2010, all dietary supplement manufacturers have been required to comply with the Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP’s) according to the guidance outlined in USP chapters,, and.
<2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements – This chapter provides tests for the estimation of the number of viable aerobic microorganisms present in nutritional supplements, from raw materials to the finished products.
<2022> Microbiological Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements- Good manufacturing practices require that objectionable organisms be absent from non-sterile nutritional and dietary products. A microorganism can be considered objectionable if it represents a potential health hazard to the user who is using the product as directed, or if it is capable of growing in the product.
<2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements - The development of the formulation of nutritional or dietary supplements includes an evaluation of raw materials and their suppliers and the contribution made to the products by each ingredient and the manufacturing processes. Guidelines to help determine the appropriate tests to establish the microbial content of each ingredient are found in chapter.
The BioLumix system can perform all of the microbiological assays needed to get the finished product to the marketplace faster than traditional methods.
1. Microbial results can be generated in 24-48 hours in assays such as Total Aerobic Count, Yeast and Mold, Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa while utilizing one system.
2. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference.
3. The BioLumix system has software that is 21 CFR Part 111 compliant and BioLumix generates a customized validation book for each of its customers that include: Installation qualification (IQ), Operational qualification (OQ), and Performance qualification (PQ).
Cosmetic and Toiletry USP Chapters There are three USP chapters that are most important to the cosmetics and toiletry industries, <51>, <61> and <62>:
<51> Antimicrobial Effectiveness Testing - The ultimate purpose of the Preservative Efficacy Test (PET) is to determine the effectiveness of the preservative(s) present in a cosmetic or toiletry product. USP Chapter describes the type of products to be tested (categories), the specified microorganisms to be used for testing, and the inoculum and log reduction amounts required per category of product. The product to be tested is inoculated with a high number of bacteria, yeast, and mold, and the reduction in the initial inoculum amount is calculated over a 28 day period.
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests - Suitability testing is performed in order to verify that the method utilized eliminates the effect of any antimicrobial properties of the product. Therefore, the media diluent combination does not inhibit the recovery and growth of microorganisms, if present in the sample. The goal of the suitability testing is to establish the ability of the test to detect microorganisms in the presence of product. The suitability described in USP verifies the validity of the testing method by showing the recovery of microorganisms in presence of the product.
Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms – Suitability testing using USP is performed by using selective media to detect various organisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, bile-tolerant gram-negative bacteria, Clostridia, Salmonella and Candida albicans in the presence of the product. The samples are first enriched by incubating in Trypticase Soy Broth (TSB) or another appropriate neutralizing media, and then streaked onto selective agars for the determination of presence of specified or the objectionable microorganisms.
The BioLumix Advantage for Suitability and Preservative Efficacy Testing (PET)
BioLumix offers innovative microbiological testing solutions designed specifically for the cosmetic and toiletry industries, including Microbial Limits (microbial enumeration of total aerobic counts and yeast and molds, and objectionable organisms), Suitability Testing and PET, all inclusive in one system.
• Offers a rapid automated method for determining the suitability of the product to grow microorganisms and determine the effectiveness of the product’s preservative(s).
Time Saving: You can see results an entire day early if the product is exhibiting any sort of inhibition.
• Preservative Efficacy Testing or Challenge Testing (USP), Microbial Enumeration Testing (USP), and Testing for Specified Microorganisms (USP) can be easily performed without the hassle of preparing and counting multiple plates that would be expected using the standard methodology yielding faster results and being more cost effective.
• Labor Saving: The setup of the assay can be done much faster using the BioLumix system as opposed to traditional plating methods, saving significant hands-on labor due to its automation and simplicity of use.
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