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.
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.
Routine microbiological testing carried out by the pharmaceutical, 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 mandatory chapters and numbers >1000 are considered informational chapters.
Pharmaceutical USP Chapters
USP offers some standardized test methodologies and material specifications relating to microbiological quality and control so as to ensure product quality and safety.
<1111> Microbiological Examination of Nonsterile Products:Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use – It is suggested that certain categories of products should be tested routinely for total microbial count and for specified indicator microbial contamination. The relevant tests for determining the total count of viable aerobic microorganisms and the total combined yeast and mold count and for detection and identification of designated species are given under Microbial Limit Tests <61>.
<1115> – Bioburden Control of Nonsterile Drug Substances and Products – This chapter deals with the bioburden of non-sterile drug substances and products. The chapter states that the biggest manufacturing risk for these products is the ingredient water. Process water is the single most important risk factor contributing to the contamination of nonsterile products. The purified waters that are used in manufacturing are deionized and do not contain chlorine that helps control microbial growth. Purified water is capable of supporting growth of gram negative rod shaped bacteria and many different molds.
<1116> Microbiological Control and Monitoring of Aseptic Processing Environments – The purpose of this chapter is to review the various issues that relate to aseptic processing of bulk drug substances, dosage forms, and to the establishment, maintenance, and control of the microbiological quality of controlled environments.
<1117> Microbiological Best Laboratory Practices - This general information chapter outlines what is needed to improve the effectiveness, efficiency and inspection-readiness of a Microbiology Laboratory in respect to media preparation, microbiological cultures, lab equipment, laboratory layout, lab records, interpretation of results, training, and documentation.
<1223> Validation of Alternative Microbial Methods – The purpose of this chapter is to provide guidance for validating methods for use as alternatives to the official compendial microbiological methods. Validation of microbiological methods is the process by which it is experimentally established that the performance characteristics of the method meet the requirements for the intended application, in comparison to the traditional method. Traditional plate methods for microbiological testing require long time to results, highly trained microbiologists, is labor intensive, and creates a bottleneck for product release. Rapid microbiological methods (RMMs) offer a high degree of automation, significant reduction in time to results, reduced staff training, faster product release, and improved process control.
<1227> Validation of Microbial Recovery from Pharmacopeial Articles – This chapter
provides guidelines for the validation of methods for the estimation of the number of viable microorganisms, for the detection of indicators or objectionable microorganisms, for the validation of microbiological methods used in antimicrobial effectiveness testing, and for the sterility testing of Pharmacopeial articles. It is generally understood that if a product possesses antimicrobial properties because of the presence of a specific preservative or because of its formulation, this antimicrobial property must be neutralized to recover viable microorganisms. This neutralization may be achieved by the use of a specific neutralizer, by dilution, by a combination of washing and dilution, or by any combination of these methods.
<1231> Water for Pharmaceutical Purposes – According to USP <1231>, although there are no absolute microbial standards for water (other than water intended to be sterile), the cGMP regulations require the establishment of appropriate specifications. The specification must take into account the intended use of the water; i.e., water used to formulate a product should contain no organisms capable of growing in the product. Action or alert limits should be established based upon validation data and must be set low enough to signal significant changes from normal operating conditions.
BioLumix Rapid Microbiology Methods offer innovative new testing solutions that are designed specifically for the challenges of the pharmaceutical industry, including a multitude of microbial tests for raw materials, in-process and finished products, as well as, the capacity to perform environmental and water testing. This simplifies, expedites, and reduces the cost of performing microbiological assays.
The BioLumix Drug Master File (DMF) entitled “Microbiological Rapid Method for the Detection and Enumeration of Microorganisms in Pharmaceutical Products” has been accepted by the US Food and Drug Administration (FDA). The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs. The DMF can be referenced by drug manufacturers, reducing FDA review times and accelerating the regulatory approval process for use of the BioLumix System. In addition, Over the Counter (OTC) products can be tested in conjunction with the BioLumix Validation Package.
Many pharmaceutical, cosmetic, and toiletry products contain preservatives that help extend the product’s shelf life, keeping spoilage at bay for a certain period of time, and also act with antimicrobial properties if microbes are introduced. A consumer dipping a finger into a jar of facial cream has introduced microbes into the cream, and the preservative should effectively kill or reduce the number of microorganisms (for more information on preservative effectiveness, please read the blog “Preservative Efficacy Testing: Guidelines to an Automated Simplified Testing System”).
Why we need suitability testing? The measurement of preservative test requires the ability to count the number of surviving microorganisms after exposure to the antimicrobial agent in the product. Bioburden (also called microbial content) testing has the same requirement because the assay depends on the ability to recover viable microorganisms in the presence of potentially antimicrobial in the product or raw materials. Carryover of residual inhibitors from the product could inhibit growth in the recovery medium, leading to poor microbial recovery. This potential residual activity must be neutralized and it is necessary to demonstrate the adequacy of neutralization for the test. This demonstration of neutralization in compendial microbiological tests is known as demonstration of method suitability.
Therefore, before conducting any microbiological test, it is important to find the most effective neutralizing agent or dilution that will create a suitable environment for growth, allowing for accurate results during microbial content and preservative efficacy testing.
How to test for Suitability- Suitability in the presence of product is the ability of microorganisms to grow when introduced in low numbers. Following the plate count method for suitability in USP Chapter <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS, the appropriate growth media alone (control) and the product (test) are inoculated with 10-100 cfu. The inoculated product is then diluted 1 to 10. If growth occurs on control plates, but does not grow on test plates, or counts are half that of the control plates, neutralization or further dilution may be necessary to show suitability of product.
How to Neutralize Inhibitors- Depending upon the type of product and the inhibitory system being tested, different diluents should be used as some products may require neutralization of a strong preservative that would suppress growth of naturally occurring microbes. Table 1 below summarizes some neutralizing agents used in common neutralizing broths such as Modified Letheen Tween (MLT) broth, D/E Neutralizer, and Tryptone Azolectin Tween (TAT) broth among others.
Sometimes, even the use of a neutralizing agent may not be enough, and dilution further than 1 to 10 may be necessary. It is important to keep in mind that five different organisms are being tested in one product, and what allows one organism to grow might not work as well for another. Essentially, it is important to find any and all different parameters that make a product suitable for inoculation.
Once a proper neutralizer or dilution is found for each product and organism, microbial content testing and PET testing can proceed. Without performing suitability testing first, microbial content testing and PET may yield false negative results; bacteria, yeast or mold may be present, but simply remain dormant until the optimal growth conditions are introduced.
The suitability test can be performed very simply and quickly with the BioLumix system.
Use of BioLumix System for suitability testing- The BioLumix system is capable of determining whether a product meets suitability standards. Products and controls are inoculated, then 1.0 mL is added to the BioLumix vials, entered into the instruments, and initial results may be observed within 18-24 hours. The figure shows examples of curves obtained from the BioLumix system using Staphylococcus aureus with various preservative systems. The top picture shows a product that is properly neutralized. While as the bottom picture demonstrates that without proper neutralization, product can hinder the growth of organisms.
In the BioLumix instrument, if the detection time (DT) of the media without product is within a couple of hours of the product containing media it means that enough neutralization is achieved. If there is a DT without the product in the positive control; but the sample containing vial does not have a DT it means that the product prevents the growth of bacteria and a different neutralization scheme needs to be employed.
What are the advantages of the BioLumix system? Time Saving: The results are available much faster, for example, the results of the Yeast and Mold vials occurred in less than 48 hours, instead of five days for countable colonies. All products tested with bacteria using the automated BioLumix assay yielded results typically within 10-18 hours, instead of 48 hours for the plate count methodology. The advantage using the BioLumix system is that you can see results an entire day earlier if the product is exhibiting any sort of inhibition.
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.
High Correlation with USP: The BioLumix System showed a high correlation between the instrument results and the USP methodology.
Neogen Corporation (NASDAQ: NEOG) announced today that, effective Sept. 30, it has acquired all the outstanding stock of BioLumix, Inc., an Ann Arbor, Mich.-based manufacturer and marketer of automated systems for the detection of microbial contaminants.
The BioLumix business will be consolidated with Neogen’s closely related Soleris® technology, which is widely used for the detection of spoilage organisms in several food industries, as well as the nutraceutical market. The Soleris system was the first in the industry used for the detection of microbial contamination based upon an innovative application of well-accepted classical microbiology.
“Combining of the Soleris and BioLumix technologies, market bases, and outstanding technical staffs will greatly enhance both businesses and offer significant labor saving rapid solutions for the food, pharmaceutical, and personal care businesses,” said James Herbert, Neogen’s chief executive officer and chairman. “The combination also settles litigation of seven years between the two companies, and benefits existing customers of both companies moving forward.”
The BioLumix test platform includes an instrument where test vials are incubated and automatically read for results, and an automatic system to alert users to sample results. The basic unit accommodates 32 different test vials at a time and can be combined in modules to accommodate up to 1,000 different samples simultaneously.
Test vials are the consumable portion of the platform and contain growth media and indicators for a number of different microorganisms. A sample is simply added to the vial, and the vial inserted into the instrument. BioLumix currently has 19 different microorganism tests. Specialized software shows test results as soon as detections occur, and avoids the need for involvement from a hands-on operator. The software also creates and maintains all the necessary audit trails to comply with various government regulations.
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