Join Neogen at ASM2015

Neogen invites you to visit them at booth #674 at the American Society of Microbiology (ASM) General Meeting coming up next month from May 30 — June 2.

Held at the Ernest North Morial Convention Center in New Orleans, ASM2015 is
one of the largest microbiology conferences and Neogen will be exhibiting their leading microbiological testing products.

Neogen has a suite of microbiological testing products, including dehydrated culture media – Acumedia.  Neogen also has pathogen detection methodologies for food matrices. These tests are often used in conjunction with Neogen’s line of Acumedia product. More information on Neogen’s Food Safety division and foodborne pathogen detection systems can be found here.

In addition to the traditional and pathogen detection methodologies, Noegen also has the BioLumix system. The BioLumix system helps customers rapidly test finished goods, raw materials, or in-process commodities for bacteria, yeasts and molds, and other objectionable organisms. One of the key features of the BioLumix system is the 48 hour certificate of analysis. Dietary supplement and nutraceutical companies are able to maintain compliance with certain aspects of 21 CFR part 111 using the BioLumix system. Also, the validation book helps our customers easily survive audits and come as a package deal with the BioLumix system from Neogen.

If you aren’t familiar with the type of information that’s presented at ASM, the agenda can be found at: http://gm.asm.org/. The opening session of the meeting provides a scope of the 2014 program, which can be viewed in its entirety here.

To help solidify your knowledge and keep you up-to-date in the evolving world of microbiology, there are also several educational sessions at ASM2015. These included everything from overviews on pathogenic organisms, to detection and characterization developments. Additional interesting topics include transmission of pathogens, evolution of microbes, and even natural food trends as they relate to microbiology. Posters and sessions related to food microbiology can be found at: ASM2015.

Whether you are a manufacture, a researcher or a student, Neogen would love for you to stop by their booth to talk more about microbiology and discuss the food safety solutions we have available. ASM2015 is shaping up to be another great conference and Neogen is looking forward to hearing what exciting things you’re learning while you’re there.

Join Neogen at Ingredient Marketplace 2015

By Joe Heinzelmann

Join Neogen at booth #528 from April 7th – 9th for Ingredient Marketplace 2015 at the Orlando World Center Marriott.

Ingredient Marketplace brings together experts in the community of nutrition,
health, food and beauty products and provides opportunities for networking, purchasing and business development. Additional insights from educational programs include global insights, and categorical trends.

Neogen is a world leader in food safety, and excited to showcase new solutions to facilitate cGMPs, quality assurance programs, and verification systems at Ingredient Marketplace. Neogen will be presenting new, key products that have been validated specifically for nutritional, health food, beauty and other related products and include the BioLumix System, allergen control tests and plans, as well as hygiene monitoring equipment.

The BioLumix Rapid Microbiology System saves time, reduces staff involvement, and leads to faster product release. The validated BioLumix system also allows for easy compliance with cGMP, streamlining your microbiological testing and once again saving you time, labor and money. BioLumix delivers shorter sample preparation, automated real-time communication, fast product release and early warning of contamination. The system is also paperless and efficient, saving on disposables, time and space, while eliminating product interference, and delivering accurate results.

The BioLumix system is also fully automated, validated against USP
methodology
and supports 21 CFR Part 11 Compliant. The system delivers complete microbiology testing results within 24-48 hours, allowing for faster product release time and shorter sample prep time.

In addition, Neogen’s allergen testing solutions help companies put together best practices for allergen control. Neogen’s industry supported Supplier verification document starts with raw materials. Using testing and best practices, companies can have confidence that ingredients, sanitation teams and their products all comply with allergen label claims.

Please also visit Neogen at booth #528 to hear more about AccuPoint Advanced, Neogen’s newest and most complete hygiene monitoring system and to see a demonstration as to why the AccuPoint Advance is the right tool for the job.

The value of raw material screening for dietary supplement and nutraceutical companies

By Joe Heinzelmann

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.

Key questions:

  • 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.

References:
http://www.ahpa.org/Portals/0/pdfs/14_0923_MMcGuffin_Neogen_GMP_Overview.pdf
http://www.nsf.org/newsroom_pdf/preview_ds_sourcebook.pdf

 

Year-end wrap up: Rapid microbiology in 2014

By Gerry Broski and Ruth Eden

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 with your products 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.

 

Laboratory Information Management System (LIMS) in the Microbiology Lab

By: Paul Dudley

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. [1]

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.  [3]

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.

Efficiency

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.

Paperless

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 [5] .  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 [5] .  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 [6] .

Cost Reduction

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 [3] .  Another lab saw a 50% increase in throughput two years after implementing their LIMS [7] .  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.

Compliance

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> [9] .  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.

SOURCES:
1. http://www.thermoscientific.com/content/tfs/en/products/lab-information-management-systems-lims.html
2. http://www0.cs.ucl.ac.uk/staff/B.Tagger/LimsPaper.pdf
3. http://khemia.com/clients/case-studies/
4. Ruth Eden, Ph. D., Neogen Corp.
5. Food Quality Magazine (http://www.foodquality.com/details/article/5621151/The_Paperless_Microbiology_Laboratory.html?tzcheck=1)
6. http://www.labmanager.com/laboratory-technology/2010/01/the-paperless-lab?fw1pk=2#.VIISO8mRJtY
7. http://www.labnews.co.uk/features/taking-lims-to-a-hire-level/
8. http://www.scientific-computing.com/features/feature.php?feature_id=246
9. http://www.mybiolumix.com/BioLumix-System-rapid-microbiological-methods

 

The Relevance of USP Methodology in Microbiology for dietary supplements and cosmetic products – Part 2

By: Jennifer Johnson

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).

For more information click here.

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 Relevance of USP Methodology in Microbiology in Pharmaceuticals

Microbiology in Social Media

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

microbiology newsNews 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:

American Society for Microbiology

ScienceDaily – Microbiology News

The Scientist

The Independent

microbiology newsBioLumix News and Information:

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

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:

Small Things Considered

Microbiology Network Blog

Pharmaceutical Microbiology

The RMM Blog

MicrobiologyBytes

microbiology blogBioLumix Blog:

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.

microbiology emailE 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.

Social Channels

microbiology linkedinLinkedIn:

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.

Examples of relevant discussion groups:

Rapid Microbiology Testing and Methods

Rapid Microbiology

Microbiology Professionals

Food Microbiology- HACCP

Pharmaceutical Microbiology

BioLumix on LinkedIn:

BioLumix at LinkedinBioLumix 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 linkedin group

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

BioLumix on facebook
Facebook:

BioLumix at facebookFacebook defines social media today and is more of a pure social media, than it is used for personal purposes. However, in recent years it started serving also in the promotion of companies and services.  Many companies have Company Pages that can promote their service or products with information and special offers.

BioLumix on Facebook: To view the BioLumix Facebook page click on the icon.

BioLumix at TwitterTwitter:

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.

A few examples:

MicrobeWorld

Microbiologybites

SfaMicrobiology

MicrobiologyNet

BioLumix at TwitterBioLumix on Twitter:

To view the BioLumix Twitter page click on the icon.

Google +

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.

BioLumix at Google+BioLumix on Google+:

To view the BioLumix Google+ page click on the icon.

BioLumix at YouTubeYouTube:

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.

A few examples are:

Microbiology video library

Microbeworld Video

BioLumix at YouTubeBioLumix on YouTube:

BioLumix has posted many videos on-line explaining the technology and dealing with a variety of topics of interest to microbiologist. To view the BioLumix YouTube videos click on the icon.

Usage Survey

A year ago Scott Sutton and the Microbiology Network conducted a survey of the use of social media by microbiologists in a few regulated industries.  There has been a significant increase in the use of social media by scientists and microbiologists as these sources provide an opportunities to keep current with the latest in news and developments in virtually any area of interest to the microbiologist.

Social Media Survey ResultsThis 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.

Conclusions

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

The Complete BioLumix Experience! Simplified, Rapid, Automated BioLumix System: Microbiology Testing Simplified

Come to Booth #16091 @ Supply Side West 2014 and Learn More
SupplySide West ExpoThe implementation of cGMP for all manufacturers (large and small) of dietary supplements and Nutraceutical products means that all manufacturers must test their products for microbiology quality assurance and generate a Certificate of Analysis for each batch. Products must be tested in accordance with the methods described in USP <2021> and <2022>.  This includes testing for Total Aerobic Microbial Count, Total Combined Yeast and Mold, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organisms such as Salmonella, E. coli, and sometimes S. aureus). To do these tests companies either send product samples to contract laboratories for microbiological testing or test them internally.

Internal testing of products for microbiology gives the manufacturer much more control over the operation, but some manufacturers are hesitant to bring the microbiology testing in-house for fear of the complexity of testing or the need for trained microbiologist(s).  Also daunting is the need for a full validation package which is required for any method that deviates from the USP methodology. Here’s the good news – BioLumix offers a solution that gives faster time to results, quicker product release, cost effective operation, and strengthens key profit drivers.   This is all achieved on a single platform that is easy to use, validated to USP requirements, and doesn’t require additional skilled personnel.

At BioLumix, we don’t just offer you a simplified, rapid, automated microbiology system… we provide the Complete BioLumix Experience!

What is the Complete BioLumix Experience?  It’s having, from initial contact to the completion of the installation and beyond, our commitment to providing unparalleled support and total customer satisfaction.
SupplySide West Expo show floor

 

In 2006, Ruth & Gideon Eden established BioLumix, Inc.  Today, because of their extensive backgrounds in science and technology combined with customer-oriented sales and support staff, we have raised the simplification, automation and speed of microbiology testing to a new level.

  • Needs Assessment - Whether you contact us direct or through our website you can count on our sales team to respond quickly.  The focus is on your needs and goals.  Our BioLumix Technology Presentation provides an in depth look into how and why our system will work for you.  In addition, we can quickly and easily show you the value and the ROI the system will bring to your company.

 

  • Expertise – Knowing how the BioLumix system will work with your samples gives you peace of mind.  That’s why we test samples – YOUR samples – for you at our laboratory in Ann Arbor, MI.  We do this for you at no cost and at no obligation!  Once completed, expect a comprehensive report from one of our expert microbiologists. That same microbiologist spends two and a half days on-site for training and installation of the system.

 

  • Validation – If you are concerned about validation, here is more good news.  We provide complete SOPs along with a customized Validation book which includes Installation Qualification (IQ), Operations Qualification (OQ) and Performance Qualification (PQ).

 

  • Simplicity and Ease-of-Use-  The easy to master BioLumix system offers a new level of productivity.  Sample preparation takes less than 2 minutes; just add the sample to the diluent and mix.  Pipette the appropriate amount into the vial and place it into the instrument and record the sample and assay information into the computer.  The rest is totally automated.  The Certificates of Analysis will automatically be generated in as little as 24-48 hours!

 

  • Support – Our jobs center on satisfying our customers and providing unparalleled support.  At BioLumix you receive 24/7 support plus a microbiologist dedicated to service you and answer your questions.  What happens if you encounter a problem? Troubleshooting can be done via the internet and in most cases problems are resolved.   If needed we provide a loaner instrument while your instrument is being fixed to minimize downtime.  Our website provides instant access to information and resources about our technology, instruments, assays, and more.  It’s also mobile-enabled to format to your handheld devices.  Links to social media, white papers, blogs, videos, and other informative contact information puts everything you need at your fingertips.

 

  • Continuous Product Improvement – At BioLumix we have an ongoing commitment to evolving and adding to our platform.   One way this is achieved is through our partnership with our customers.  Customer feedback, along with a desire to increase the breadth and depth of our offerings, helps us to make improvements to our media and our assays.  We have recently introduced two new assays – Listeria and Bacillus cereus.

 

With a simplified method such as the BioLumix System we can provide a simple cost effective method to test products for microbiology. Come visit our booth (# 16091) and take the first step into your own personal BioLumix Experience.  This year the show is being held at the beautiful Mandalay Bay Convention Resort, in Las Vegas, October 8th and 9th.

RAPID MICROBIOLOGY METHOD BENEFIT BOTH LAB SERVICE PROVIDER AND MANUFACTURERS

 

 

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.

Lab Quality Assurance“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?

BioLumix VialsSUREN: 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.”  Validation BookWe 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. 

Water testing- Heterotrophic bacteria, coliforms and E. coli- Why and how to test

Water Quality

Water QualityWater is used in a variety of different industries as well as products within various industries, including Nutraceutical and Dietary Supplement, Pharmaceutical, cosmetics, toiletry industries.  Water can be used as a product ingredient, for example, to create the capsules that contain the supplement.  In the manufacture of the capsules many companies use their own water to create and encapsulate their products.   Water is also used for the cleaning of certain equipment and contact surfaces.

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.

Control of the microbiological quality of water is important for many of its uses. All packaged forms of water are required to be sterile because some of their intended uses require this for health and safety reasons. The needed microbial specification for a given bulk water depends upon its use. Some applications may require even more careful microbial control to avoid the proliferation of microorganisms ubiquitous to water during the purification, storage, and distribution.

To ensure adherence to certain minimal microbiological quality standards, water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141) issued by the U.S. Environmental Protection Agency (EPA) or the drinking water regulations of the European Union or Japan, or the WHO drinking water guidelines. Microbiological requirements of drinking water ensure the absence of coliforms, which, if determined to be of fecal origin, may indicate the potential presence of other potentially pathogenic microorganisms and viruses of fecal origin. Meeting these microbiological requirements does not rule out the presence of other microorganisms, which could be considered undesirable if found in a drug substance or formulated product.

USP<1115> deals with bioburden of non-sterile drug substances and products, and the chapter states that the biggest manufacturing risk is water as an ingredient.  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.

Water TestingThe FDA also covers a wide range of different types of water that can be used for pharmaceutical uses and describes different sources for water contamination.  The FDA even states that microbial contamination of oral liquids and topical drug products are a significant problem that is usually caused by contaminated water.  Due to the potential health risks involved with the use of contaminated water, particular attention should be paid to the deionized (DI) water systems, especially at smaller manufacturers.

Chlorinated water may be appropriate for early stage cleaning and sanitization activities, but the uses are risky and should only be used on a case by case basis.  Microbial enumeration is an integral component of a water monitoring system to assess the microbial quality of the water.  Some systems use both high-nutrient (PCA) and low-nutrient (R2A) media to allow the isolation of both heterotrophic organisms and slower growing oligotrophic bacteria.

Water testing is also important when dealing with well water, tap water and even bottled water.  The EPA uses coliform as an indicator of possible fecal contamination.  Coliforms naturally found in the environment, and are usually non-pathogenic, but their presence may indicate fecal coliforms.

The Rapid Automated BioLumix System

BioLumix SystemBioLumix automated; all-in-one microbial testing system is an ideal system for in plant water testing.  The system is fast, simple and cost-effective.  A novel optical system sensing color and fluorescence in ready-to-use vials provides faster results, labor savings, automation, and connectivity. The BioLumix system is capable of testing water for heterotrophic bacteria, total aerobic bacteria, E. coli, coliforms, fecal coliforms and yeast and molds. Using the BioLumix system will quickly determine the microbial quality of the water.

Heterotrophic Vial: This vial can detect organisms requiring low-nutrient media (similar to (R2A) to allow the isolation of both heterotrophic organisms and slower growing oligotrophic bacteria. In a study, over 50 samples of multiple different water types were tested by the BioLumix method and the plate count method side-by-side.  The BioLumix vials were directly inoculated with 0.1 mL of the water sample, or a 1.0 mL of a 1:100 dilution, and a few samples were inoculated with heterotrophic bacteria.  The samples were monitored in the BioLumix instrument for 35 hours.  The results showed that the BioLumix system was roughly 13 hours faster than the plate count method using Stand Methods Agar.  These particular samples were tested at specified levels <10 cfu/ml and <100cfu/ml, but the BioLumix method can detect organisms at levels of <1 cfu/ml of water.

Bottled water for human consumption also needs to be tested for coliforms, which are indicators of possible contamination. The FDA requires either MPN or membrane filtration to check 100 ml of water for any contamination. The MPN method which requires at least nine tubes to perform the test and up to 96 hours of testing; while BioLumix can do the same analysis using just one vial in less than quarter of the time.  The filter method can also be applied using the BioLumix system by filtering the 100ml onto a membrane filter and placing the filter directly into the vial.

What are the advantages of the BioLumix system?

The system serves, as a platform to perform all required assays- using the BioLumix system will allow the users to test for coliforms, heterotrophic bacteria, E. coli and Yeast/Mold. The system can be used for water testing as well as for testing raw materials, in process and finished products.

Saving time- The BioLumix system can save time when testing water for Heterotrophic bacteria instead of taking three days using traditional plates, the BioLumix system will give the same results in 35 hours.

Economical cost of assays: Instead of running an MPN assay, which will require up to 5 days of testing as well as 9 tubes of LTB and up to 9 tubes of EC Media to wait for confirmation of a positive fecal coliform, the BioLumix system requires less than 24 hours and a single vial.

References:

http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072925.htm -Water for Pharmaceutical Use

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm064948.htm  Enumeration of Escherichia coli and the Coliform Bacteria

USP <1115> Bioburden Control of Nonsterile Drug Substances and Products

USP <1231> Water Treatment Systems For Industrial & Commercial Use.

TIPS FOR SUCCESSFUL ENVIRONMENTAL MONITORING

Putting together an environmental monitoring plan requires a thoughtful, scientific approach establishing and considering the risks of contamination from each location along the manufacturing process.
environment monitor
WHY MONITOR THE ENVIRONMENT?

Environmental monitoring (EM) is a basic requirement across many regulated industries such as food, cosmetics, Nutraceutical, dietary supplements, and pharmaceuticals. It measures the degree of maintaining environmental control and, therefore, the safety of the manufactured products. Maintaining environmental control can prevent product contamination.

The FDA evaluates the environment of manufacturing facilities against the regulatory code, and the potential of the product allowing for growth of organisms. They expect manufacturers to be in control of the environmental conditions in their facility. There is evidence that a relationship exists between the level of environmental control and the final quality of the product. In product safety, the EM program serves a critical role that the environment is under appropriate control.

In manufacturing facilities, there is a need to demonstrate that production equipment is sufficiently clean thereby the next production lots are not contaminated from the material of the previous lot.

An effective sampling plan needs to be established, the purpose of a microbial EM program is to:
• Provide crucial information on the quality of the work process environment during manufacturing
• Prevent future microbial contamination by detecting and reacting to adverse trends
• Prevent the release of a potentially contaminated batch if the appropriate standards are not met
• Prevent the risk of contamination of the product
• Ensure there are environmental controls in the production areas
• Provide a profile of of the microbial cleanliness of the manufacturing environment.

SITE SELECTION FOR DATA COLLECTION

The site’s selection for data collection should show the effectiveness of cleaning. Such as:
• Site where the product is exposed to people and equipment
• Critical sites that can change product integrity if compromised
• Areas and processes steps where microbial contamination must not happen, such as the final filling of the product into its containers.

In establishing an EM plan, the number and location for sampling sites should be established. When choosing the sampling sites, there needs to be a good representation of risk-based sites where the environment can affect the product quality. Examples of such location include areas that are difficult to clean, or areas close to critical operations.

For sterile products, the manufacturer needs to keep the bioburden of the pre-sterilization as low as possible. There is a need to monitor the air, water, personnel, and surfaces as they all can contribute to the bioburden.
For non-sterile, low bioburden products, there are two main reasons for monitoring the environment:
1. To keep product bioburden under control
2. To know if the environmental isolates could contain objectionable organisms.

Other important questions to consider include:
? What is the antimicrobial effectiveness of the product?
? Will the product promote microbial growth?
? If so, which organisms can grow and get around the inhibitors build into the products?

ESTABLISH A BASELINE

Before initiating an EM program, it is recommended to get a baseline of total aerobic count, Yeast and mold count, perhaps coliform or Enterobacteriaceae, and in some instances lack of objectionable organisms on surfaces and the air. Establishing a baseline also allows for assessments of the types of organisms present, and helps in developing a scientifically sound disinfection program to address chemical kill and physical removal of such contaminants. The data subsequently collected during microbiological performance qualification, and routine monitoring helps to validate the efficacy of disinfection and cleaning procedures.

CHOOSE SUITABLE METHOD FOR EM

method for monitoring - swabsMost EM is done by plate counting of colonies on agar media, which is simple and inexpensive. However, plate count methods are slow, requiring two to seven days to complete, thereby causing a delay in the detection of contamination, which can lead to an increase in product loss, plant downtime and expensive cleanup. Delays can cause increasing inventory holding cost. The delay in obtaining results impacts reaction to contamination issues and can make investigations very difficult. The plate count methodology is also labor-intensive and requires manual data entry and documentation. Such documentation is prone to human errors and compliance issues.
Methods are available to measure total particles in the air, including Total Organic Carbon (TOC), and Adenosine Tri-phosphate (ATP).These methods are very fast to perform but do not correlate well with total bacterial count or any specific group of organisms, and do not measure viable organisms (Carricket al., 2001; Easter, 2010). Therefore, these results do not measure viable organisms in the environment or on production lines.

WHY BIOLUMIX

why BioLumixThe BioLumix system is useful for rapid and simple monitoring of the manufacturing environment. A large validation study was performed (Eden and Brideau 2012) to show that is correlates well with the plate count method. The BioLumix system was validated as an alternative to the plate count method for EM. The study involved 549 surface coupons representing five diverse types of material. These five surfaces represent those encountered in manufacturing, including metal, plastics and rubber. Some of the coupons were inoculated with bacteria, yeast, or mold. There was 100% agreement between BioLumix assay and the plate count assay for the 260 coupons that were determined to be below the specified level by the plate count method. There was an overall agreement of 97.2%between the two methods when swabs containing counts above the specified level were used. In general, discrepancies in swab results between the BioLumix vial method and the traditional plate count method reflected marginal samples that were very close to the specified testing level, and thus were variable.

REFERENCES

Carrick, K, Barney M, Navarro, A. and Ryder D. (2001). The Comparison of Four Bioluminometers and Their Swab Kits for Instant Hygiene Monitoring and Detection of Microorganisms in the Brewery. J. Institute of Brewing 107, 32-37
Easter M. (2010) A comparison of commercial ATP hygiene monitoring systems. Next Generation Food issue 9, 2010.
Eden, R. and Brideau, R. (2012). Validation of a Rapid System for Environmental Monitoring and Water Testing. In Environmental Monitoring Volume 6, Jeanne Moldenhauer, Ed

The versatility of the BioLumix System – One system for all your microbial needs.

Why go to an automated system?

There has been a growing awareness over the years that utilizing the current methodology for determining microbial contamination is not cost effective due to the slow turnaround.  Internalizing the microbiology testing and especially adopting rapid microbiological methods (RMM’s) can speed up significantly the time to results from 7-10 days to 15-48 hours.  An automated detection system provides contamination information earlier than the conventional method, products can be released faster, manufacturing at risk is minimized, and investigations can be conducted and concluded closer to the time of the actual contamination.  The obvious benefit of an automated system is the quicker release of finished products, where the shorter ‘time to result’ may generate considerable cost savings. Some of the other advantages of RMM can include greater accuracy, better sensitivity, increased sample throughput, and automated data capture allowing easier data handling and paperless laboratory.

Why You Should Invest in the BioLumix System?

BioLumix SystemTime is money.  For a nominal investment in automation, the BioLumix Rapid Microbiology System will save valuable days in the QC process: optimize operations; increase throughput; and directly impact company profitability!  The BioLumix system allows for all of your microbiology needs to be met with one automated system.  It can be used to test Raw, In-process, and Finished Materials along with environmental and water samples.  The BioLumix system allows the user to test as frequently and as broadly as desired without significant cost or delays. The results are increased capacity along with cost reduction, improvement of logistics, and overall better efficiencies! With shorter sample preparation time and automated data entry, data archiving, report generation, and product release, the BioLumix system simplifies and automates your laboratory procedures. Tests can be also be performed by non-microbiologists, providing significant savings in laboratory labor.

Advantages of the BioLumix System

1)      All assays performed on a single system.  This allows laboratories to purchase one system but offer and perform many different tests, thus eliminating the problem of finding space for multiple systems in the lab and training personnel on multiple instruments.

a)      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.  The system is unaffected by product interference and delivers accurate results. BioLumix is dedicated to producing affordable and easily performable assays that laboratories of all sizes can integrate into their daily work flow and yearly budget.

b)      BioLumix has improved the way microbiology can be performed in the cosmetic, toiletry and pharmaceutical industries.BioLumix has improved the way microbiology can be performed in the cosmetic, toiletry and pharmaceutical industries.  BioLumix offers the first automated PET and Microbial Limits system on a single platform, without any product interference! Preservative Efficacy Testing or Challenge Testing (USP<51>), Microbial Enumeration Testing (USP<61>), and Testing for Specified Microorganisms (USP<62>) 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.

c)      Environmental Monitoring.  In manufacturing facilities there is a need to demonstrate that the production equipment and environment are sufficiently clean so that the next production lot will not be contaminated by the material from the previous lot, removing the potential of cross contamination. One needs to prove with high degree of certainty that the cleaning process was effective. To do so an effective sampling plan needs to be established.  The BioLumix system can be utilized for rapid and simple monitoring of the manufacturing environment.

d)    Water Testing. Water is widely used as a raw material, ingredient, and a solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients and intermediates.Water Testing As such, all water purification systems must be monitored regularly to verify the quality of the water produced. Monitoring of water for microbiological quality may include testing for total heterotrophic plate count, coliforms/E. coli, or by checking for the presence of other organisms suspected to be present in a water sample. The relevant standards relating to pharmaceutical grade water are USP <1231> Water for Pharmaceutical purposes.

2)      Scarcity of skilled personnel: Microbiology laboratories face major challenges such as the growing scarcity of skilled laboratory workers and the burden of the ever-increasing workload.  The BioLumix system requires limited training to successfully set up the tests.  The system is fully automated including archiving of data, data maintenance and report generation, and it can be used to create a paperless laboratory.

3)      In house testing allows a laboratory to be more cost effective.  Increased turnaround time may be one of the most appealing features of an automated system.  Contamination can be caught quicker and actions can be taken immediately so that products can be released faster into the marketplace.

4)      The Validated BioLumix System.  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 <2021>, <2022>, and <2023>.  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:

a)      Installation qualification (IQ):  Identification and validation of the system components; validation of the environmental conditions; electrical requirements; computer qualification; verifying that all installation steps were followed; and documentation of instrument calibration.

b)     Operational qualification (OQ):  Verifying that the equipment is properly installed calibrated and is operational.  It includes a unique SOP for all products and assay combinations to be performed on the instrument; software characteristics and the verification that the software is 21 CFR part 11 compliant; verification that all the instrument functions operate as expected; Verification of the instrument temperature accuracy; and training records.

c)      Performance qualification (PQ): is the most extensive part of the BioLumix validation book. It shows equivalency with USP methodology when following USP <1223> “Validation of alternative microbiological methods”.

 

 

References:

1)       United States Pharmacopeia Chapter  <51> Antimicrobial Effectiveness Testing

2)       United States Pharmacopeia Chapter  <61> Microbiological Examination of Nonsterile Products:  Microbial Enumeration Tests

3)       United States Pharmacopeia Chapter  <62> Microbiological Examination of Nonsterile Products:  Tests for Specified Microorganisms

4)       United States Pharmacopeia Chapter <1231> Water for Pharmaceutical Purpose

5)       United States Pharmacopeia Chapter <2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements

6)       United States Pharmacopeia Chapter <2022> Microbial Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements

7)       United States Pharmacopeia Chapter <2023> Microbial Attributes of Non-Sterile Nutritional and Dietary Supplements

8)       United States Pharmacopeia Chapter <1223> Validation of Alternative Microbiological Methods

Growth Promotion and Negative Controls – Does Shipping Affect the Results?

Why Growth Promotion?

USP Chapter <61>, Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests ,there is a requirement for the testing of Growth Promotion (GP) for each batch of medium as well as testing for Negative Controls (NC).  Growth Promotion must be tested for each new batch of nutritive broth.  The purpose of the GP Test is to determine the suitability of the culture media for the growth of target organisms.  The medium is challenged with a small number (not more than 100 cfu) of microorganisms to assure its nutritive properties.

USP Chapter 61USP Chapter <61> lists the following acceptance criteria for liquid medium: “Liquid media are suitable if clearly visible growth of the microorganisms comparable to that previously obtained with a previously tested and approved batch of medium occurs.” It is recommended to use parallel testing; in parallel testing the new medium and the previously approved medium are inoculated with the same microorganism suspension, by the same technician, using the same method and same environmental conditions.  The only variable is the medium. GPT is performed by inoculating the product with ? 100 CFU of microorganisms, defined by the pharmacopoeia.

BioLumix Quality Assurance and Certificate of Analysis

For every batch of vials prepared by BioLumix a thorough testing, including growth promotion and negative controls, is done.  Growth promotion is tested performed, for each organism, by inoculating 4 vials of the new lot and comparing the detection time (DT), and amplitude of the curve to a lot that previously passed the PG. At least 2 different strains of organisms are used in each media.  Additionally at least one negative control organisms is tested and compared to the reference.  In the growth control assay the DT of the new lot has to be within a range of 50-200% from the reference vial.  A certificate of analysis is issued with each lot of vials.

Is there a need to redo GP and NC after shipping the vials to the end users?

In other words, does the shipping of the vials to the end users influence the GP and NC of the vials? The study described below was undertaken to answer this question.  BioLumix vials are always shipped UPS second day air.  The furthest destination in the USA is California.  The study was conducted by double shipping second day air to California and back.

Summary of Validation Data

Methodology-Quadruplicate vials that were shipped to California and were returned from there where compared to vials that stayed in the lab. This test was performed on three different lots of media, using three different media types (Total Aerobic Count, Enterobacteriaceae, and Yeast and Mold Vials).

Results-The data shows that the shipped vials and the vials that stayed in the laboratory results of the test show identical growth curveshad identical growth curves, falling close to each other.   There is no difference in growth promotion or negative control between vials that were shipped (actually double shipped) and vials that stayed on the shelf for any of these lots, as can be seen from the attached example.  The example compares the curves of total aerobic count vials (TAC) inoculated with Bacillus spizizenii var subtilis ATCC 6633, shipped to vials that remained in the laboratory (Key: Shipped vials: Purple, Yellow, Beige and Dark Green; vials that remained in the lab: Dark Blue, light Green, Light Blue and Red lines). As can be seen from this example the Curves are indistinguishable

Similar results were obtained for all three lots of TAC inoculated with Bacillus spizizenii var subtilis ATCC 6633; Escherichia coli ATCC 8739; and Staphylococcus aureus ATCC 6538;

A buffer was used as a negative control for the TAC vials, and no difference was seen for all three lots between shipped and vials that remained in the lab.

Similar results were obtained with combined yeast and mold vials (YM) inoculated with Aspergillus brasiliensis ATCC 16404; Candida albicans ATCC 10231; Saccharomyces cerevisiae ATCC 9763; and Staphylococcus aureus ATCC 6538 (SAT1) as negative control.  There is no difference in growth promotion or negative control between vials that were shipped and vials that stayed.

The shipping experiment was also conducted with Bile-Tolerant Gram-Negative Bacteria vials (ENT) inoculated with Escherichia coli ATCC 8739; Salmonella enteritidis subsp. enterica serovar enteritidis ATCC 13076; Citrobacter freundii ATCC 8090; and Staphylococcus aureus ATCC 6538 as a negative control. There was no difference between the data generated by the system for shipped vials, as compared to vials that remained in the laboratory.

 Conclusion

The data shows that the shipped vials and the vials that stayed in the laboratory had identical growth curves, falling on top of each other.   There is no impact of shipping on growth promotion or negative control.  The results validate that there is no reason to perform again the growth promotion and negative controls after shipping to the end user. The C of A supplied with the BioLumix vials is indicative of Growth Promotion and Negative Control followed the shipping.

BioLumix Simplified, Rapid, Automated Microbiology on Display at Ingredient Marketplace 2014 in New York

BioLumix Simplified, Rapid, Automated Microbiology on Display at Ingredient Marketplace 2014 in New York

May 5, 2014 by Linda Schmaler & Paul Dudley
Since its beginnings in 2006, BioLumix, Inc. has been on the leading edge of technology in the world of microbiology.  On June 2 – 3, 2014, that technology will be on display at Ingredient Marketplace 2014 at the Jacob Javits Center in New York City.  This year, BioLumix has added a new assay to its already robust line of test vials: Listeria

Ingredient MarketplaceSupplySide Marketplace has changed its name to Ingredient Marketplace, and is built upon the theme, “What’s Inside Matters.”  With consumers seeking safer, healthier products, manufacturers today are more focused than ever on providing their products to satisfy their demands while at the same time coming up with effective ways to improve both their products and the means by which they are brought to market.  This is where BioLumix can make a difference!

The BioLumix System monitors changes in broth medium in which target organisms grow.  Microbial metabolism causes the reagents on the proprietary vial to change their color or fluorescence, and real-time monitoring of these changes by optical sensors provide immediate feedback.  This means that a sample that tests above spec is known right away.  The optical sensor monitors vials in the testing unit 10 times per hour.

BioLumix provides test vials for a wide range of assays:

  • Total Aerobic Count
  • Coliform
  • Enterobacteriaceae
  • Yeast and mold count
  • Gram negative bacteria
  • Heterotrophic bacteria
  • Sterility testing
  • Preservative efficacy test
  • Microbial limits
  • Suitability testing
  • Pseudomonas aeruginosa
  • Staphylococcus aureus
  • Escherichia coli
  • Listeria
  • Bacillus cereus
  • Lactic acid bacteria

Listeria VialThe impact of the BioLumix automated rapid microbiology system can be realized in a wide variety of benefits:

  • Ready-to-use vials come with a Certificate of Analysis
  • All confirmation steps are done directly from the vial
  • Certificate of Analysis (C of A) for all assays produced within 48 hours
  • Customized Validation Package in compliance with USP <2021>, <2022>, <2023>, or USP <61> and <62>
  • Automated real-time monitoring for rapid results
  • Ease-of-use – the system can be operated by non-microbiologists, which can allow microbiologists to perform other tasks
  • Centralized data processing and archiving for easy management of results
  • Same-day Total Aerobic Counts and Coliform results
  • Yeast and Mold results within 48 hours
  • Objectionable organisms can be tested on the same platform

These benefits translate into significant business advantages, such as early detection of problems, faster product release, product validation, improvements in factory and lab capacity, lower cost of inventory, and reduced cost of capital.  In addition, all installations include real-time, 24/7 support by a dedicated BioLumix microbiologist.

Please join us at Ingredient Marketplace 2014, and be sure to stop by our booth (417).  For more information, visit http://www.mybiolumix.com.

Are You Ready for an FDA Inspection? Surviving the Audit

When it comes to facility audits, tensions run high, even for the most prepared.  When your facility is being audited, the documents used for evaluation come from the Code of Federal Regulations, 21 CFR 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements).  These documents review specifications, responsibilities to meet those specifications, written procedures, and laboratory operations.  Here, we focus on the microbial aspect of these requirements.

Microbiology Lab Ready for FDAWhat specifications must you establish?

For dietary supplements, specification limits must be set on contaminants that may adulterate (change) or lead to adulteration of the in process or finished batch.  Documentation as to why these specifications will help to ensure contaminants will not lead to adulteration should be in place.  It is your responsibility to ensure the established specifications are met and properly documented.

What steps should be taken to make sure specifications are met?

Appropriate testing should be in place to be sure specifications are within compliance.  You may also rely on a certificate of analysis (C of A) from the supplier of the component that you receive provided you first qualify that supplier’s certificate of analysis through testing.  If you rely on the suppliers C of A, it should include a description of the testing performed, specifications, and actual results of the test.  Periodic auditing of C of A results is required, and should be part of the microbial testing.  To ensure the finished product specifications are met, the in-process procedure should be in place to monitored and make sure that  unanticipated contamination does not occur at any stage.

Requirements for Laboratory Operations

Written procedures (Standard operating Procedures-SOP), for laboratory operations for tests and examination of product must be in place.  Lab operations should ensure that all lab material specifications and dietary supplement specifications are met.  Test methods should be well documented and validated, and sample-collecting plans should also be in place and followed.

Out of Specification Operations

If specifications are not met, a procedure (SOP) must be present and followed to correct for any error made during processing or testing.  A modified method of testing may be necessary.

Microbiology Lab RequirementsThe Validated BioLumix System

BioLumix generates a customized validation book for each of its customers that include:

Installation qualification (IQ):  Identification and validation of the system components; validation of the environmental conditions; electrical requirements; computer qualification; verifying that all installation steps were followed;  and documentation of instrument calibration.

Operational qualification (OQ):  Verifying that the equipment is properly installed, calibrated and is operational.  It includes a unique SOP for all products and assay combinations to be performed on the instrument; software characteristics and the verification that the software is 21 CFR part 11 compliant; verification that all the instrument functions operate as expected; Verification of the instrument temperature accuracy; and training records.

Performance qualification (PQ): is the most extensive part of the BioLumix validation book. It shows equivalency with USP methodology when following USP <1223> “Validation of alternative microbiological methods”.

BioLumix has some quick tips to be sure that your BioLumix system passes inspection without any fuss.

How to Use the BioLumix Validation Book?

Your customized validation book is a major component in your system, just like the instruments and vials themselves.  Make sure the person in charge of validation knows exactly where the validation book is.  Also, be sure that all pages of the book requiring signatures, are signed by the appropriate personnel, and the operator has a good grasp on the meaning of each attachment.  The training log of attachment 9 should show that appropriate training was provided to all operators.  All SOPs used in product testing must also be included in the book.

Side-by-Side Testing

Attachment 16 in the validation book shows your company’s own product testing and the data generated not only with the BioLumix system, but with the USP plate count method as well.  It generally starts with the report that was generated when samples were first sent to BioLumix for testing.  Since then, your company should have added to this data to show continuity between the BioLumix and plate count methods.  Attachment 18 is much more in depth, showing a wide variety of products, vial types, and specification limits.  This data verifies the comparability between the two methods on a broad spectrum.

Vials and Reagents

Make sure that the vials and reagents in use are within their expire dates.  Also be sure the Certificate of Analysis matches the vials.  It may seem like common sense, but when days get busy, some things may be overlooked.  Be sure all reagents are stored at the proper temperature conditions as specified by BioLumix.

Optical Calibration

It is important that your instruments be calibrated optically at least every 6 months, and full temperature and optical calibration be performed annually.  These documents should be held in Attachment 8 of your validation book.  This will show that care was taken to keep the instruments performing at optimal levels.

By following these guidelines, you should be ready for your audit.  As always, BioLumix is just a phone call away with any questions or concerns you or the auditor may have.

It is important for all to know that BioLumix customers pass FDA microbiological audits without any problems.

BioLumix Exhibits at Engredea March 2014!

Join BioLumix at booth #616 in Anaheim March 7th – 9th, 2014 for Engredea 2014 at the Anaheim Convention Center.

Engredea 2014: Anaheim, CAEngredea brings together the community of leading suppliers and manufacturers of new ingredients, packaging, technologies, equipment, and services in the global nutrition industry. Engredea, co-located with Natural Products Expo West, is the only trade show that brings together the full food chain of supply to shelf.

The BioLumix Rapid Microbiology System  delivers significant reduction in time to results, reduced staff involvement,  and faster product release.  BioLumix can save multiple days versus current testing methods and dramatically impact key profit drivers. The validated BioLumix system allows for easy compliance with cGMP. BioLumix will streamline your microbiological testing saving significant time labor and money.  BioLumix delivers shorter sample preparation, automated real-time communication, fast product release and early warning of contamination.  It is paperless and efficient, saving on disposables, time and space.  The system eliminates product interference, delivering accurate results. Engredea 2014: Anaheim, CA

Driving Profit Ability!
With BioLumix Rapid, Automated Microbiology you can view microbiology product testing from a position of company strength and competitive advantage!  Streamline your microbiological testing, reduce cost, increase efficiency and show rapid return on investment.  The BioLumix system is 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.

Why Visit us at Booth #616?

Be sure to stop by the BioLumix booth (#616) to view a product demo and inquire about our special show pricing.  Be sure to examine our numerous product literature and scientific white papers.

We would like to show you how the BioLumix System will make your company more efficient and add profits to your bottom line!  For a nominal investment in automation, the BioLumix Rapid Microbiology System will:

Save valuable days in the Microbiology Quality Control Process

Optimize Operations

Increase Throughput    AND…..

Directly Impact Company Profitability!

We look forward to the opportunity to earn another satisfied customer!

BioLumix Validation Book for Dietary Supplements

According to cGMP all dietary supplement products should to be tested in accordance with the methods described in USP <2021> and <2022>. The required assays might include Total Aerobic Microbial Count, Total Combined Mold and Yeast, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organism such as Salmonella, E. coli, and sometimes S. aureus). To do these tests companies either send product samples to contract laboratories for microbiological testing or test their samples internally.  Many outside laboratories utilize BAM and AOAC methods that were never validated against the USP methodology for Dietary Supplement products.

BioLumix Validation BookFDA’s GMP inspection program for dietary supplements has evolved since its debut a few years ago, with the agency increasingly strict in its interpretations of the regulation and requirements.  Validation of any new microbiological method is required prior to entering its use in the commercial arena. The validation assures equivalency of the new method to the reference method. This means that the new technique or device is giving us “real results” that are reproducible and that can be trusted. USP <1223> Validation of alternative microbiological methods and ISO 16140 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis.

BioLumix generates a customized validation book for each of its customers. The book includes:

Installation qualification (IQ):  Identification and validation of the system components; validation of the environmental conditions; electrical requirements; computer qualification; verifying that all installation steps were followed;  and documentation of instrument calibration.

Operational qualification (OQ):  Verifying that the equipment is properly installed, calibrated and is operational.  It includes a unique SOP for all products and assay combinations to be performed on the instrument; software characteristics and the verification that the software is 21 CFR part 11 compliant; verification that all the instrument functions operate as expected; Verification of the instrument temperature accuracy; and training records.

Performance Qualification (PQ):

Performance qualification is the most extensive part of the BioLumix validation book. It shows equivalency with USP methodology when following USP <1223> “Validation of alternative microbiological methods”.

  • Side-by-side comparison: Side-by-side results are comparable between the BioLumix method and the reference method when testing by the BioLumix Dilute-to-Specification Protocol.   A generic study was performed testing all types of Nutraceutical, botanicals and dietary supplements for Total aerobic count. A total of 252 samples with counts in the range of 100 cfu/g to 10,000,000 cfu/g   were analyzed, including   botanical powders, botanical extracts, infusions, alcohol extracts, raw materials, and finished products. There was a 99.6% agreement between the BioLumix method and the SP plate count method. Testing similar products for yeast and mold counts in the range of 10 cfu/g to 100,000 cfu/g there was a 98.1% agreement; and for Gram negative Bile Tolerant bacteria 98.7% agreement.  Similar results are shown for all objectionable groups of organisms such as E. coli, S. aureus, P. aeruginosa, and Salmonella.  Unique customer samples are also tested and compared to USP results.
  • Specificity (Inclusivity and Exclusivity): is the ability of the media in each vial to detect a wide range of organisms belonging to the target group, and not detect using non-target organisms, which demonstrates that the method is fit for its intended purpose.  The inclusivity and exclusivity of each of the media used by the system was extensively studied.  The data shows good inclusivity and exclusivity.
  • Limit of detection (LOD):  are the lowest microbial counts in a sample that can be detected under the conditions used.  The limit of detection was evaluated for Total Aerobic count, Yeast and Mold count and Gram negative Bile Tolerant bacteria.  The data shows that for all 3 media the limit of detection was close to 1-3 cfu/vial.
  • Precision and Repeatability:  is the degree of agreement among individual test results when repeatedly testing multiple samples of suspensions of microorganisms across the range of the test.  It is usually expressed as standard deviation (SD) or coefficient of variation (CV) of a series of measurements. Generally, a %CV of 15%-35% is acceptable. All the results obtained were well within the acceptable range.
  • Robustness: indicates the capacity of the device or technique to absorb small variations such as: incubation conditions, incubation temperature, media and sample volumes, etc.   The data demonstrates the robustness of the system with various media.
  • Ruggedness: is related to the reproducibility of the results considering different equipment (different instrument units), personnel, different lots of reagents, etc.  The BioLumix system has been demonstrated to be very rugged with high precision of test results obtained by analyzing the same microorganisms under a variety of different operating conditions including different analysts, different instrument units, and various  lots of media.
  • False negative rate: A false negative is a test in which samples that are inoculated or naturally contaminated generate a positive result in the reference method (plate count) but are negative in the test method (BioLumix). Naturally contaminated samples were tested at various specification levels, the BioLumix procedure detected the samples as being contaminated in all cases while the plate count method had a false negative result.
  • False positive rate: A false positive is a test in which a sample that does not contain the target organism generates a positive result in the BioLumix system but not in the Plate Count method. A false positive rate of 2.5% was seen in total aerobic count and no false positives were seen in the yeast and mold assay.

Conclusion

There is a need for rapid microbial detection technologies in order to improve the quality of products and their safety and speed up time to results. Their benefit could include significant reductions in time-to-result over conventional methods, improved sensitivity, specificity and accuracy, benefits of automation, reduced requirements for staff training, rapid product release, and lower inventory.  New rapid automated methods in microbiology need to be validated, and the BioLumix system comes with a validation book.

  • Unique validation book created for each customer.
  • Single platform testing for all assays
  • 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
  • Technology based on traditional media
  • Stackable compact instruments take up little bench-top space
  • Technical service available 24/7

References

Food  and  Drug  Administration  (FDA)  (2007),  21  CFR  Part  11,  Guidance  for Industry; Electronic Records; Electronic Signatures – Scope and Application. The National Formulary, Rockville, MD

United States Pharmacopeia (USP) (2008), Chapter <1223>, Validation of Alternative Microbiological Methods. The National Formulary, Rockville, MD

United States Pharmacopeia (USP) (2008), Chapter <2021>, Microbial enumeration tests-Nutritional and dietary supplements. The National Formulary, Rockville, MD

United States Pharmacopeia (USP) (2008), Chapter <2022> Microbiological procedures for Absence of Specified Microorganisms- Nutritional and dietary supplements. The National Formulary, Rockville, MD

Rapid Automated Testing of Probiotic Organisms

Definition and Health benefits of Probiotics: The World Health Organization’s 2001 definition of probiotics is “live micro-organisms which, when administered in adequate amounts, confer health benefits on the host”.[1] This definition, although widely adopted, is not acceptable to the European Food Safety Authority because it embeds a health claim which is not measurable.[2] Etymologically, the term appears to be a composite of the Latin preposition pro (“for”) and the Greek βιωτικος(biotic), the latter deriving from the noun βιος (bios, “life”) [3].

Health benefits: Some digestive disease specialists are recommending the use of probiotic organisms to help in the treatment of disorders that frustrate conventional medicine, such as irritable bowel syndrome. Since the mid-1990s, clinical studies have established that probiotic therapy can help in the treatment of several gastrointestinal ills, may delay the development of allergies in children, and both treat and prevent vaginal and urinary infections in women.

Examples of Probiotic Organisms: There are hundreds of strains of probiotic bacteria. The most commonly used organisms include Lactobacillus sp. (such as L. acidophilus, L. casei, L. fermentum , L. rhamnosus) Bifidobacterium sp, (such as B. Bifidum, B. lactis and B. longum), Streptococcus thermophilus, Bacillus coagulans,and Enterococcus faecium.
Potency Testing: Probiotics offer a broad range of health benefits. As with any supplement, the efficacy of a probiotic depends on dosage. Essentially the titer of live organisms is the critical part in determining potency. Recommending an adequate dose for an individual patient requires clear knowledge of the potency of a product. Probiotic potency is specified as the numbers of viable cells of the beneficiary organism. Confidence in the accuracy of this number is essential for successful and consistent clinical results.
Enumeration of bacteria has been a routine practice in microbiology for over 100 years. The gold-standard method used to determine the titer of organisms is known as the viable plate count that is used to generate a count referred to as colony forming units (CFU). On probiotic product labels, results are expressed in CFU per serving. Since probiotic cells are sensitive to their environment, potency is subject to change. Therefore, potency must be determined after manufacturing, shipping and storage. Thus the supplement industry needs a rapid, accurate, and reliable method for testing of probiotic organisms is therefore needed. BioLumix offers a novel rapid method for enumeration of Probiotic organisms.

BioLumix Methodology for Potency Testing:
A calibration curve is generated to easily relate the number of colony forming units determined using the plate count method to the detection times (DT) in the BioLumix instrument. These calibration curves are embedded into the instrument software and are used to access the number of probiotic organisms present in the product sample for individual organisms. An example is shown in the Graph for the Lactobacillus acidophilus. Currently, individual calibration curves are available for the following organisms: L. casei, L. acidophilus, L. rhamnosus, L. bulgarus, B. coagulans, B. longum, B. bifidum, E. feacalis, and S. thermophilus. The procedure used to test sample cultures involves a single 1:10,000 dilution of the sample followed by the addition of 0.1 ml to the appropriate test vial. Organism growth may occur rapidly, often in less than 24 hr, and the BioLumix instrument generates an estimate of the cfu per gram of sample. This is a much more rapid method than the traditional plate methods that often takes 3-7 days for Lactobacillus species. Using the BioLumix rapid method can be much less expensive than traditional plate methods for Lactobacillus species as these organisms often require specialty media under conditions of low oxygen (candle jars).

Microbial contamination: Good manufacturing Practices must be applied in the manufacture of probiotic containing products. Contamination of probiotic products with undesirable microorganisms is possible in uncontrolled fermentation and during handling. Therefore, most probiotic batches need to be tested for indicator organisms such as coliforms and to also show the absence of potentially harmful organisms such as E. coli, Staphylococcus and Salmonella.

BioLumix Methodology for Microbial Contamination: The BioLumix simplified automated system can detect indicator organisms and objectionable organisms, if present, in a fraction of the time of traditional methods, with significantly less hands-on time. The system offers a wide variety of rapid assays for samples, including assays to detect yeast & molds, coliforms, E. coli, Staphylococcus, Pseudomonas and Salmonella.

References
1. Schlundt, Jorgen. “Health and Nutritional Properties of Probiotics in Food including Powder Milk with Live Lactic Acid Bacteria”. Report of a Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. FAO / WHO.
2. Rijkers, Ger T.; De Vos, Willem M.; Brummer, Robert-Jan; Morelli, Lorenzo; Corthier, Gerard; Marteau, Philippe (2011). “Health benefits and health claims of probiotics: Bridging science and marketing”. British Journal of Nutrition 106 (9): 1291–6.
3. Hamilton-Miller, J. M. T.; Gibson, G. R.; Bruck, W. “Some insights into the derivation and early uses of the word ‘probiotic’”. British Journal of Nutrition 2003 (90): 845.

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

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

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

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

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

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

Simplified, automated microbiology testing

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

ALL assays available within one automated system

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

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

Product reports tailored to specific applications

Dedicated microbiologist assigned to support your    facility

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

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

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

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

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

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

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

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

BioLumix System Saves Valuable Time in Yeast and Mold Testing

Rapid Microbiology Yeast and Mold TestingIf you are a microbiologist, or work in close relation with a laboratory, you probably already know that yeast and mold testing is one of the longest quality control processes. Both the plate count and the membrane filtration techniques used by many microbiology labs often take between 5-7 days to complete, and this ends up costing you and your organization valuable time and money in the mean time. The BioLumix rapid microbiology system is based on cutting edge knowledge of the microbial metabolic process, and is the most versatile method around when it comes to the expedient detection of microorganisms. For the nominal cost of our automated testing systems, your company could shave several days off of their production and distribution time, and secure a catalyst that will increase profits for years to come.

Yeasts and molds constitute a large and diverse group of microscopic foodborne fungi, totaling several hundred different species. One of the main reasons that these organisms are so successful in attacking foods and cosmetics is their versatility, having very broad temperature (5-60 ?C) and acid/alkaline (pH 2-pH 9+) requirements for growth. This means yeast and mold are capable of invading crops, such as those producing grains, nuts, beans, and fruits both before harvesting and during storage, and can also make their way into our processed food. In many cases Yeasts and molds are not immediately visible, however these fungi can cause varying degrees of deterioration and decomposition in products, with the manufacturer only discovering their presence when it’s too late.

Several different kinds of molds and yeasts can be hazardous to humans and animals due to their ability to produce toxic metabolites called mycotoxins. These metabolites are stable compounds, and the performed toxins are usually not destroyed during food processing, or even when cooking at home. Other yeasts and molds can also cause allergic reactions or infections, especially in immunocompromised demographics, such as the elderly, the young, the debilitated, or those undergoing antibiotic and chemotherapy treatment. To make matters worse, yeasts and molds often cause products to spoil after they have left the processing facility, posing potentially a health hazards and product quality issues to the consumers. For this reason, a wide range of industries require that companies test their products for yeast and mold before they go on sale. In a nutshell, the quicker you can produce and quality test products, the quicker you can get your inventory to market, and the more profitable you will be.

This value proposition is the premise upon which our rapid microbiological testing system was founded. The BioLumix system is committed to simplifying, expediting, and reducing the cost of performing microbiological assays so that companies can bolster production with a fraction of their current working capital. Our ready to use vials are capable of detecting yeast and mold in 48 hours, saving 3-5 days when compared to plate count and membrane filtration techniques and keeping more money in your pocket.

optical technology for yeast and mold testingThe keys to our systems celerity are its patented CO­­­2 sensors and optical technology, which continuously monitor growth media in each vial. Because yeasts and molds are obligate aerobes, they must take in oxygen and release Carbon Dioxide (CO­­­2) in order to grow. This cellular respiration is part of the Krebs cycle, and is used by all aerobic organisms to generate energy. When the sensor detects the presence of CO­­­2 it is a sign that microbial growth is present. The optical sensor simultaneously takes readings of the vials at 6 minutes intervals, detecting changes in color, and allowing for rapid detection of growth. Results are easy to interpret and can be automatically transmitted via a multitude of communication channels to its needed location, such as a warehouse or production facility to expedite shipping of a safe product. Our fully automated system can also be operated by a non-microbiologist, reducing labor by up to 60%, and allowing skilled scientists to spend their time in the lab more efficaciously. With less tedious work, microbiologists can turn their attention to higher value tasks, such as interpretation of data and product safety analysis, making your lab far more efficient.

With the BioLumix rapid microbiology system, labs can revolutionize the way that one conducts their quality control process. Our platform makes production times shorter, products safer, and recalls less frequent and far less costly. Adding value and increasing lab productivity with BioLumix will allow your organization to thrive, and will put you in a position to be successful for years to come.