Back to Back: BioLumix Attends Nutracon, Engredea and will be Featured in the Innovation Station during Engredea

February 14th, 2012

Where & When?

March 7th-8th, BioLumix will be attending Nutracon at the Anaheim Hilton hotel for the first time ever in 2012, due to overwhelmingly positive feedback from both our customers and prospective customers about the show. Shortly after the Nutracon show, BioLumix will take its place in Booth #321 for the three day show, Engredea, March 9th – 11th. During this time, BioLumix will be featured at the Innovation Station located within the Engredea show floor.

Are cGMP Regulations Driving Up Your Costs?

Learn how we can save you time and money! Streamline your microbiological testing, reduce cost, increase efficiency and see rapid return on investment with the BioLumix system. BioLumix is fully automated, validated against US methodology, 21 CFR Part 11 Compliant system that allows for Complete microbiology testing results within 24-48 hours, allowing for faster product release time, shorter sample prep time – saving time, money and other resources. BioLumix was chosen as one of the most significant innovations in Engredea 2012-Don’t miss us at the innovation station

Why Visit us at Booth #321?

Be sure to stop by the BioLumix booth (#321) to view a product demo, meet some of our customers to learn the benefits that the system brought to them and inquire about our show special pricing. Examine our numerous product literature and scientific white papers.

The BioLumix System is completely modular, able to handle the microbiological testing needs of both large and small companies. In most cases a Return-On-Investment can be proved within 6 months. We truly believe the BioLumix System will make your company more efficient and add profits to your bottom line! Don’t just take our word for it, speak to our customers directly.

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Confirmation Testing of Presumptive Positive Assays Using the BioLumix System

January 27th, 2012

In Microbiology, the initial test result using selective or differential media is called Presumptive Test. Most presumptive tests require confirmation. Confirmation can be accomplished using specific reagents and materials. However, due to the critical importance of testing for pathogens and/or objectionable organisms as contaminants; it may be necessary to perform identification of any organisms isolated from samples. Identification measures microorganisms to the species level.

Initial Testing

For testing of any sample for the presence of microorganisms it is critical to perform a measure of total organism counts (viable organisms). BioLumix provides testing for both Total Aerobic Counts (Bacteria) and for Total Yeast and Mold Counts (Fungi). The BioLumix system in this regard mimics testing for both bacteria and fungi using USP or BAM plate methodology. In these initial tests for total counts there isn’t any discrimination of objectionable organisms from common organisms and common flora. Objectionable organisms for Nutraceutical Samples as an example may include E coli, Staphylococcus aureus, Salmonella or Pseudomonas aeruginosa.

Use of Selective Media

For most samples, it will be necessary to test for at least some objectionable organisms. In order to perform tests for each specific objectionable organism it is necessary to use selective media specifically designed to select for the target organisms. For example, for E coli testing, it is necessary to use selective media that contains both inhibitors that prevent the growth of non-E coli organisms and substrates that can utilized by E coli and not by most other microorganisms. BioLumix make use of such a media, referred to as the EC vial.

Confirmation Test

Unique confirmation tests that can be performed directly from the vials are described for the various objectionable organisms.

E. Coli- Indole Test

For samples that grow and detect in the BioLumix system, a series of Confirmation Tests can be utilized to begin the process of understanding whether the organism(s) are genuine E coli or not. For E coli testing a common initial confirmation test is the Indole Test using the Kovacs reagent. The Indole Test measures the presence of any indole in the growth media as a by-product of tryptophan metabolism by E. coli. Figure 1 depicts a negative (yellow ring) and positive Kovacs Reaction (Red ring) at the top of the media in the test vial.

Staphylococcus aureus – Coagulase Test

The BioLumix vial for testing for the presence of Staphylococcus aureus contains inhibitors of non-Staphylococcus organisms and substrates, such as mannitol as the sole carbon source used by S aureus. If growth is found in the BioLumix STA vial, the analyst can begin to confirm the presence or absence of S. aureus, directly from the vial, using the classic coagulase tests. The coagulase test that has been used for decades uses a known antisera specific for S. aureus epitopes. When S aureus is present, the antiserum reacts with the specific epitopes and forms a lattice of antibody-antigen, and the material coagulates within hours. Figure 2 illustrates the coagulase positive (upper tube) and negative (lower tube) reaction.

Pseudomonas aeruginosa- Oxidase Test

The BioLumix vial for testing for the presence or absence of Pseudomonas aeruginosa contains inhibitors such as Centrimide to prevent the growth of non-pseudomonads and substrates for use by P. aeruginosa. If growth is found in the BioLumix PSE vial, the analyst can begin to confirm the presence or absence of P. aeruginosa using the classic oxidase test. When P. aeruginosa is present, the oxidase test strip reacts with the centrifuged precipitate material (bacterium) and yields a rapid dark blue reaction. This reaction is based on the presence of certain cytochrome oxidase that are found intracellularly in the P. aeruginosa.Figure 3 illustrates the positive oxidase color test ( + ) from the negative reaction ( – ).

Salmonella- Immunoassay Strip

The BioLumix vial for testing for the presence of Salmonella contains inhibitors of non-salmonella bacteria and substrates utilized by Salmonella. If growth is found in the BioLumix SAL vial; the analyst can begin to confirm the presence of absence of Salmonella using commercially available test kits that typically make use of Immunological reactive endpoints. One such kit is shown in the cartoon (Figure 4) and depicts immuno-reactive bands on a test strip.

Identification

Any negative confirmation assay indicates that the target organism is absent and the result is negative. However, in the rare occasions that the vial shows growth and the confirmation assay is positive, it does not necessarily mean that an objectionable organism is present. In these situations further identification of the growing organism might be required. The growing organism could be isolated on selective or non-selective medium and identified by any appropriate identification system.

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Testing Nutraceutical Products in the cGMP Era: Questions and Answers

January 11th, 2012

Questions to Dr. Ruth Eden

With the full implementation of cGMP’s for dietary supplements, what are the changes that you have seen in microbiology testing and inquiries regarding how to comply with the regulations?

The 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. The products need to be tested in accordance with the methods described in USP <2021> and <2022>. Products need to be tested for Total Aerobic Microbial Count, Total Combined Mold and Yeast, 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. Many outside laboratories utilize BAM and AOAC methods that were never validated against the USP methodology for Dietary supplement products.

Any method that is different from the USP methodology (manual or equipment) used for microbiology testing needs to be validated prior to its use. The validation assures equivalency of the new method to the reference method. This means the new technique or device is giving us equivalent results to the USP methodology, the results are reproducible and can be trusted. USP <1223> Validation of Alternative Microbiological Methods describes the tests that need to be conducted.

Some manufactures were slow to implement the new regulations and the new methodology required for dietary supplement product testing. Others adopted methodologies from the food industry, without proper understanding of the difference between these methodologies and the USP methodologies. We get many inquiries from manufacturers that would like to save money, speed up time to microbiological results by internalizing their microbiological testing, while complying with the regulations.

What are some of the key issues surrounding microbiology testing that a manufacturer should consider when determining equipment and personnel needs for their laboratory?

Internal testing of products for microbiology gives the manufacturer much more control over the operation offering faster time to results, faster product release, and is more cost effective. Some manufacturers are hesitant to bring the microbiology testing in house for fear of the complexity of testing, the need for trained microbiologist, etc.

However, manufacturer share some common concerns when considering the internalization of microbiology testing: 1. Am I going to comply with FDA cGMP regulations? 2. How am I going to validate my testing? 3. Do I need to hire a microbiologist to internalize the testing? 4. Will this offer a return on my investment?

Also daunting is the need for a full validation package which is required for any method that deviates from the USP methodology. The validation package must properly document that the Installation Qualification (IQ) and Operational Qualification (OQ) were completed, to verify that the equipment was properly installed, calibrated and operational and that its performance are qualified. The Performance Qualification includes performance criteria such as: side-by-side comparison to the USP methodology, accuracy and precision, specificity, and range, limits of detection and quantification, along with ruggedness and robustness, reproducibility of the results, false positivity rate and false negative rate. Generating such data requires many resources.

BioLumix brings along a system that is fully validated during the system installation. With a simplified method such as the BioLumix System we can alleviate these fears and provide a simple cost effective method to test products for microbiology.

How does BioLumix plan to meet the changing requirements of dietary supplement manufacturers in implementing more precise, faster and cheaper microbiological testing in their laboratories?

BioLumix has developed a Rapid Microbiological Method that has been validated according to the FDA requirements. The validated BioLumix system is an alternative to the classic USP methodology. It is a streamlined testing system which is far less time consuming and requires less skilled technical personnel to operate. The BioLumix system offers a Certificate of Analysis for all relevant USP assays within just 48 hours. These include the FDA required tests such as total aerobic count, yeast and mold count, Bile-Tolerant-Gram -negative count, and objectionable organisms such as E. coli, S. aureus, and Salmonella. This means quarantine time for microbial testing is cut from 5-6 days to 24-48 hours for finished products, in-process and raw materials and environmental work surfaces.

Our system is fully validated during installation we perform the IQ, OQ and PQ required to fully validate the system in the customer location. We help write the appropriate SOPs, help generate the training records, and do not leave our customers until they are fully compliant.

The BioLumix testing system allows for faster sample preparation plus provides automated real-time communication, fast product release and early warning of contamination via USP microbiological testing. Because the BioLumix system is automated and its software generates the results, it is not necessary to have an employee dedicated solely to running the microbiology quality assurance tests. This makes the BioLumix system a cost-effective way for dietary supplement manufacturers to meet the new FDA cGMP requirements for microbiological testing.

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Happy Holidays

December 27th, 2011

Thanks for your continued trust in BioLumix


As we approach the end of another successful year, we would like to take this opportunity to express our appreciation to our valued customer. 2011 was a great year for us at BioLumix thanks to your continued support. As more companies are adopting our technology we have witnessed substantial increase of our customer base. As with most companies that enjoy this rapid growth, there is always the chance for the service to slide. In order to maintain excellent customer support we conducted a customer satisfaction survey to objectively measure our performance. It was gratifying to learn that all our customers indicated that they would recommend the BioLumix system to their vendors, suppliers and customers. Thank you for choosing BioLumix for your microbiological testing!

For all of you that did not yet make the leap into our Rapid Microbiology System, we hope that in the coming year we will get the opportunity to show you what BioLumix can do for you.

Our entire organization joins me in wishing you a wonderful holiday season, a prosperous New Year and we look forward to grow your business and our business relationship in the coming year. Happy Holidays and Best Wishes for a bright and successful year ahead, filled with joy and treasured moments.

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Microbiological testing of OILS

December 13th, 2011

Edible oils are an important part of the dietary supplement industry. Oils are also used extensively in cosmetics and of course, hydrocarbon based oils, are used in heavy machinery.

Oil is any substance that is liquid at ambient temperatures and does not mix with water but may mix with other oils and organic solvents. This general definition includes plant (vegetable) oils, fish or animal derived oils, volatile essential oils, petrochemical oils, and synthetic oils. Plant derived oils are used frequently in the Dietary Supplement industry and may include examples such as Flax and Sunflower oils. Fish derived oils may include the infamous Cod Liver Oil and Krill (omega 3) oils. Essential oils are generally aromatic oils and are extracted by distillation. They are used in perfumes, cosmetics, soaps and other personal care products, and occasionally for flavoring food and drink. Petrochemical oils include crude oils as an example and are naturally occurring, flammable liquids consisting of a complex mixture of hydrocarbons of various molecular weights, and other liquid organic compounds. Synthetic oils are lubricants consisting of chemical compounds that are artificially made (synthesized). Many are very similar in function to hydrocarbon based motor oils.

Plant and fish-derived oil based products are common in the dietary supplement industry and are most commonly tested in the form of liquids, soft-gels, and capsules. Cosmetic oil based-products may be in the form of creams, lotions, washes, to name a few. Oils used in products for the dietary supplement industry and in cosmetics will require testing for the presence of microorganisms.

Problems Associated with Microbial Testing of Oils


Oils can be difficult to handle due to their hydrophobic composition. An example of an oil micelle (oil present in aqueous solutions) is represented in the cartoon shown in Figure 1.

For sampling of oils for the presence of microorganisms (microbial content), it is generally necessary to first dilute the oil material 1/10 into an aqueous buffer. The material can then be mixed thoroughly (mechanically or by hand) followed by a series of decimal dilutions. Due to the lack of mixing of oil and water it is difficult to remove the organisms from micelles and transfer them to the diluent prior to making the decimal dilution and to disperse them evenly in the agar medium, all steps required for the plate count method.

The BioLumix Advantage

The BioLumix system is based upon detection of color or fluorescence variations due to microbial metabolism in liquid medium within a novel two-zone test vial. An optical sensor monitors changes in color and fluorescence within the vial’s reading zone, which is physically separated from the incubation zone. This two-zone approach prevents masking of the optical pathway by product or microbial turbidity and therefore, eliminates product interference. Separate test vials are also used to automatically detect the presence of viable microorganisms and/or to estimate the concentration of viable counts by monitoring changes in CO2 production during cellular growth.

For the BioLumix assay, oil materials diluted into TSB (1/10) and can either be used directly or pre-enriched overnight to gain sensitivity. The diluted sample is added into BioLumix vials containing broth media. A variety of vials are available to conduct any necessary assay. After the inoculation of the vials, they are inserted into the instrument that serves as an incubator and a reader. The inoculated vials are analyzed every 6 minutes and the end results are reported in an automated certificate of analysis. Most assays are completed overnight and all the results are available in 48 hours.

Results Obtained Using The BioLumix System

Table 1 includes examples of oil-containing products successfully tested using the BioLumix method including plant derived, fish derived, cosmetic oils, essential oils, industrial and synthetic oils.

TABLE 1- Types of oil tested

Plant Derived Fish Oil Cosmetic/Essential Oils Industrial/Synthetic
Flax Krill Oil Facial soaps/lotions Motor Oil
Safflower Cod Liver Oil Body (massage) VITE (dl-alpha-tocopherol)
Sunflower Omega 3 Oil Suppositories
Soybean Vitamin E Lotions
Sesame Primrose Oil

Figure 2

The clean product yields a flat curve whereas products that contain bacteria show an increase in the optical curves allowing the system to detect the presence of the microorganisms.

Similar results were obtained with motor oil (Figure 3).

The data indicates that the system works very well in distinguishing between contaminated and clean samples. It can be also used to determine the level of contamination.

High precision or repeatability was obtained for all samples tested. The BioLumix system can be used to detect the presence or absence of organisms. Assays include Total Aerobic Count, Yeast and Mold, Enterobacterial count and absence of objectionable organisms in 10 grams of product, such as E. coli, S. aureus, and Salmonella. The system is designed to speed up product release and simplify the microbiological testing of oil containing products, generating an automated certificate of analysis for all assays in 48 hours.

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A Novel Rapid Automated Method for Suitability Testing

November 29th, 2011

Suitability Testing by USP Methodology

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 <61> verifies the
validity of the testing method by showing the
recovery of microorganisms in presence of the
product. Total Aerobic Microbial Count and Total
combined Yeast and Mold can be carried out by
membrane filtration, pour plating or spread plate
method.

Suitability using USP <62> can use selective media to
detect various organisms such as: Staphylococcus
aureus, Pseudomonas aeruginosa, Escherichia coli,
bile-tolerant gram-negative bacteria, Clostridia,
Salmonella and Candida albicans. 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 new USP <61> and USP <62> tests also provide harmonization to existing European Pharmacopeia
methods for testing non-sterile pharmaceutical products. Additional in order to verify the testing
conditions, a negative control is performed using the chosen diluent that shows no growth of
the microorganisms. While conducting the suitability testing precautions must be taken to avoid
contamination so they do not affect the microorganisms that are being tested. The procedure involves
the inoculation of the neutralized sample with low (not more than 100 cfu) and detecting the organisms
by the prescribed method.

Even though USP uses traditional microbiology methods, from the USP <61> and <62> states
that “Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated” and “any validated method,
including, Rapid Methods can be used”.

The New BioLumix Method

A study was recently conducted to show the utilization of BioLumix system (see figure below) in
suitability tests using a variety of products from both the pharmaceutical and cosmetic industries.

Sampling was conducted by taking ten gram of the product
and placing it into 90ml of M Letheen broth (or another
appropriate neutralizing broth) for a final dilution of 1/10.
An overnight culture of the target organism was diluted to
not exceed 100 cfu and the inoculum not exceeds 1% of the
volume of the diluted product. Then 1.0 mL of the
neutralized sample containing organism was placed into the
appropriate vial and a side by side comparison was done
with the appropriate USP method.

The products tested included Aloe, Hand Sanitizer, Lip Balm, Flavored Lip Balm, Medicated Lip Balm,
Breath Spray, Medicated ointment, and Sun Screen. A variety of different types of each product were
tested.

32 product samples were tested for suitability. Four bacteria (Staphylococcus aureus ATCC 6538;
Pseudomonas aeruginosa ATCC 9027; Bacillus subtilis ATCC 6633 and Escherichia coli ATCC 8739; a
yeast (Candida albicans ATCC 10231), and a mold (Aspergillus niger ATCC 16404) were used to show the
effectiveness of the neutralization step. Thirty one
products were properly neutralized by the M Letheen
Broth as evidenced by detection time in the vials and
colonies on the plates. Only one product tested contained
a high level of ethanol, which required a 1:100 dilution in
M Letheen Broth to obtain neutralization. There was 100%
correlation between the two methods.

Typical data obtained by the system is shown in the figure:

The product was inoculated with ~ 100 cfu/g of three organisms: Staphylococcus aureus ATCC 6538 (light blue); Bacillus subtilis ATCC 6633 (Dark blue) and Escherichia coli ATCC 8739 (green). The Detection times obtained (shown as triangles on the curves) are comparable to data obtained without product.

What are the advantages of the BioLumix system?

Time Saving: The results are available much faster, for example, the results of the Yeast and Mold vialsoccurred in less than 48 hours, while the Aspergillus took nearly five days for countable colonies. All
products tested with bacteria using the automated BioLumix assay yielded results typically 10-13 hours,
instead of 48 hours for the plate count methodology. The advantage is that you can see results an
entire day early if the product is exhibiting any sort of inhibition. Data generation is slower using classic
microbiology so it can also slow down production improvements as well.
Labor Saving: The setup of the assay can be done much faster using the BioLumix system as opposed
to traditional plating methods, saving significant hands-on labor due to its automation and simplicity of
use. BioLumix can make the microbiological testing simpler, faster, and automated- saving significant
time and labor. It is paperless, increasing efficiency and saving on disposables, time and space, and best
of all the system is unaffected by product interference. The System is extremely easy to operate, with
its straightforward, streamlined testing design it offers accurate results leading to reduced material-
holding time for faster product release.

High Correlation with USP: The BioLumix System showed a high correlation between the instrument
results and the USP methodology. The system is fully automated with automated data archiving,
data maintenance in databases, and automated report generation. Regulators encourage rapid
microbiology methods for improved process control and product release. The BioLumix system
is validated as being at least equivalent to the compendial method. Under general notices of the
USP states that “Automated procedures employing the same basic chemistry as those assay and
test procedures given in the monograph are recognized as being equivalent in their suitability for
determining compliance.”

References:

USP <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS

USP <62>: MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TEST FOR SPECIFICIED
MICROORGANISMS

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Rapid Yeast and Mold Testing yielding Results in 48 hours

November 15th, 2011

Why test for Yeast and Molds?

Molds are agents which can be responsible for the contamination and spoilage of a variety of products. Some molds develop mycotoxins which diffuse into the product and may, if present in sufficient quantity, cause acute or chronic poisoning. The presence of yeasts may produce changes affecting product quality and salability, leading to significant financial implications for food producers.

Both yeast and mold can cause various degrees of deterioration and decomposition of products such as cosmetics, and foods. Products containing yeast and mold cells do not usually cause human illness, but high levels of these organisms can cause products to look, smell, or taste bad. This not only diminishes the appeal of the product and brand, but can also result in substantial economic losses to the producer, processor and consumer.

Yeasts are facultative anaerobe, mono-cellular fungi, fermenting sugar substrate to CO2 and H2O. Under anaerobic conditions yeasts ferment sugar to alcohol and CO2. The term “mold” is commonly used for the visible part of the fungi present on the surface of contaminated products. Fungal spoilage of food remains a serious problem, one that has been estimated to account for between 5% and 10% of all losses in global food production.

Plate Count Method for Yeast and Molds

Most industrial products are required to be tested for yeast and mold. The pate count methodology for testing yeast and molds are described in various reference publications, including Foods (Bacteriological Analytical Manual, 8th Edition, 1998. Chapter 18); Cosmetic and non-sterile Pharmaceutical products (USP <61>) and Nutritional and Dietary supplement products (USP <2021>).

The methods involve mixing the sample with a diluent followed by decimal dilutions and the addition of the diluted sample into duplicate Petri dishes, the addition of selective culture media (such as Potato Dextrose Agar, Sabouraud Dextrose Agar). The plates are incubated for 5-7 days at 20-250C, after which plates with 25-250 colonies are counted. Due to the ability of some molds to spread rapidly on the plates, the interpretation of conventional colony counts can be difficult, requiring considerable staff input. Automated methods can help reduce the possibility of human error and free up skilled technicians for other tasks.

BioLumix Rapid Simplified Assay

Principle of Operation

The BioLumix Yeast and mold vial (YM) includes a CO2 Sensor. Carbon dioxide (CO2) is a universal metabolite produced by all microorganisms. For yeast and molds, the Krebs cycle is part of a metabolic pathway involved in the chemical conversion of carbohydrates, fats, and proteins into CO2, water and energy, and as a result all aerobic organisms generate CO2. The sensor is located at the bottom of the vial. The sensor vial contains a transparent solid sensor that changes color whenever CO2 diffuses into it. The color of the sensor is dark in sterile vials. As microorganisms grow the sensor turns yellow, indicating CO2 production and metabolic growth.

A crucial element of the technology is the creation of two zones in each vial:

  • An incubation zone (upper part) for the sample and microorganisms. This zone tends to contain product debris and turbidity due to microbial growth. A reading zone (bottom part) that remains optically clear.
  • This two-zone vial eliminates interference of the optical pathway by the product and microbial turbidity. Since changes of color are monitored in the reading zone, results are not influenced by the presence of the sample or the growing microorganisms. Only gases can penetrate into the sensor that blocks liquids, microorganisms and particulate matter. The user introduces the sample by simply opening the screw cap and dropping the sample into the incubation zone.

Typical Results

The typical procedure involves the addition of the sample to a diluent followed by the addition of the sample to the ready-to-use vial. The vials are introduced into the BioLumix instrument and the rest of the operation is fully automated, including report generation.

Variety of yeast and molds where tested with the YM vial. High numbers of yeast can detect in a few hours where as single numbers detect normally in 30 hours. Mold grow a little slower, while high numbers can detect in 6-8 hours, low numbers might take up to 48 hours to detect.

variety of products were tested for yeast and molds including: Nutraceutical and Dietary supplements (multi vitamins, amino acids, enzymes, Psyllium, Spirulina, fish oil, and numerous other supplements); Over-the-Counter Pharmaceutical (soft and liquid capsules, cold remedies, vitamins and minerals, eye care products, oral hygiene products, laxatives, antacids, pain relives, to name a few); Cosmetics and toiletry products ( hand cream, Aloe concentrate, hair dye, shampoos and conditioners, tooth pastes and rinses, soaps, mascara, lipstick, foundation, and many more); Foods (cheese, yogurt, ice-cream, salad dressing, fruit pulp, etc.)

Advantages

The first noticeable advantage is that BioLumix provides results in 48 hours, compared to traditional methods, which take 5-7 days. The rapid results provided enables manufacturers to release their products into the supply chain much earlier than when testing with traditional methods.

BioLumix can make the microbiological testing simpler, faster, and automated- saving significant time, labor and money. The YM vial accelerates product release with a simplified, automated approach. This yields fast, accurate results while reducing costs.

  • Vial design prevents product interference
  • Automation and connectivity allows faster product release
  • Real-time communication for immediate action
  • Expedite results: Yeast and mold assay in 48 hours
  • Early warning of contaminated samples
  • No decimal dilutions required- direct sample introduction to vials
  • Automated data archiving and audit trail
  • Streamline testing increases laboratory efficiencies
  • 21 CFR Part 11 Compliant Software
  • Paperless laboratory: centralized test date automatically stored and protected
  • Barcode capability for automated sample entry
  • Environmental made easy

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cGMP Compliant, Rapid BioLumix System Exhibited at the Direct Sell Expo November 17th – 18th

November 2nd, 2011


BioLumix will exhibit at the second annual nutritional and cosmetic Direct Selling Expo located in the South Towne Expo Center in Sandy UT, November 17th – 18th. We invite you to come by our booth (#29) and see how our cGMP compliant Rapid Microbiological Method can streamline your microbial testing while saving you time and money. The automated BioLumix System is simple enough to be run by non-microbiologists and offers a Certificate of Analysis within 48 hours for all USP assays, including yeast and mold and all objectionable organisms!

Validated Microbiology

Dietary supplement cGMP’s require all manufacturers take steps to ensure that products are free of microbial contamination. BioLumix can help internalize microbiological testing or make the existing testing simpler, faster, and automated.

The BioLumix System is designed to accelerate product release with an easy-to-understand, reliable, cGMP compliant approach. This yields fast, accurate, real-time results while saving you time and money. During the Direct Selling Expo we will demonstrate the system, display our validation book, and show you how it can save space, time, labor and cost. Additional applications of the system such as environmental monitoring and water testing solutions will also be demonstrated.

Fast Return on Investment

In most cases a very quick return on investment can be shown. Stop by and request a free Return on Investment calculation. We have shown in most cases the BioLumix System will pay for itself within the first 6 months of ownership.

Hear What Our Customers Are Saying

“It was gratifying to learn that all our customers said that they would recommend the BioLumix System to their vendors, suppliers, and customers!” – Dr. Ruth Eden, President.

During a recent show many of our customers visited us to tell us how happy they are with their system and the only regret they have is that they did not purchase sooner.

Don’t just take our word for it, talk to our customers. We have recently conducted a customer survey and are proud to share we have 100% customer satisfaction and that all of our customers would recommend the BioLumix. Unanimously, our customers agree – the main features of the BioLumix system are: Speed to results, simplicity of use, accuracy and clarity of data presentation. You are free to contact our customers to discuss their first hand experience.

Free Product Trial

Give us your most difficult samples and we will test them for free. We will provide you with a detailed report which includes a side-by-side comparison to USP methodology along with a sample of the BioLumix 48 hour automated Certificate of Analysis. The data generated is strictly confidential and is only used to help validate the system for your company should you decide to purchase.

Follow this link to get your Free attendee badge use promo code: BioLumix.

We look forward to working with you and earning another satisfied customer!

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Social Media: The Future

October 20th, 2011

Social Media is a growing trend for both individuals and companies to facilitate communication using online vehicles. Every day, both individuals and companies are joining the Social Media circle by participating in sites such as: Facebook, Twitter and Linked In. This new platform is not only trendy; it is the communication level of society into the future.

As a young and innovative company, we knew that the next step would be to join this movement in order to help set the pace within the continually evolving field of technology. As a pioneer of new technology, BioLumix specializes in Microbiology testing for a variety of industries (Nutraceutical, Pharmaceutical, Personal Care, Cosmetics, Food, Dairy…just name it!). For BioLumix, joining Facebook is just another way that we are connecting with customers, potential customers and others interested in rapid microbiological methods.

Why Facebook? One of the reasons for joining Facebook and other social media sites in general are that since we have established our presence in the microbiology world with a wide range of customers (industry wide and worldwide), we want to be able to openly communicate with our customers and the microbiological community in the best possible way. It will allow us to enhance our relationships with others interested in better ways to test their products for microbiology. We want to spread the word to let individuals and companies know that not only will they be able to visit our website: www.MyBioLumix.com and contact us by email or telephone, anyone can now communicate with us using our new Facebook page. Additionally, pages have been launched for Linked In and Twitter.

If you are interested in learning more the BioLumix technology, feel free to contact us using any of the social media outlets. By using our Facebook page, one can ask questions, find answers, start a discussion, share ideas and connect to others that may already be using the system. Want to sign up for a free product trial? Write on our wall or send us an email for details. Further information is listed on our Facebook Company Page and can be found by clicking on “Free Product Trial.” Feedback can also be left on the Facebook Wall or emailed to us directly at: info@mybiolumix.com.

Remember The BioLumix Advantage:

  • 48 hour automated Certificate of Analysis report!
  • Real-time communication of microbiological results for immediate action – early warning of contaminated samples
  • Simplified testing with ready-to-use assay vials
  • Centralized test data processing and archiving
  • 21 CFR Part 11 compliant software
  • Validated for your product – IQ, OQ, and PQ
  • No product interference
  • Customer support 24/7/365
  • Test instruments take up little counter space and are scalable

We appreciate our customers, and as a gift to them and to those interested in becoming a customer, we will be giving away a free box of vials. In order to participate in receiving a free box of vials, become a Fan and “Like” BioLumix, Inc. on Facebook either by clicking on the link below or by searching for BioLumix, Inc. on the Facebook website. We look forward to connecting with others that are involved or interested in the field of Microbiology.

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Simple, Automated Preservative Test and Microbial Limits Test to be Presented at Cosmetic Science Symposium & Expo

October 11th, 2011

Marriott Newark International Hotel October 26th

Come and see how BioLumix can improve the way of conducting microbiology testing of cosmetic products. We would like to invite you to check out the newest innovative technology for Microbial Limits and Preservative Efficacy Testing (PET). Thanks to the growing BioLumix customer base, we are rapidly becoming a recognizable solution to today’s fast-pace microbial requirements in the Cosmetics
Industry.

BioLumix now offers the first automated PET and Microbial Limits system on a single platform, without any product interference! We have developed a Rapid Microbiological Method that has been validated according to FDA requirements*. The validated BioLumix system is an alternative to the classic USP methodology. It is a streamlined testing system which is far less labor intensive and requires less skilled technical personnel to operate. Saving up to 75% in PET labor, it will also significantly reduce consumables and testing bench-top space.

The BioLumix Optical Technology is based on continuously monitoring changes of color / fluorescence as a result of the microbial metabolism in test vials. The results are presented as soon as detections occur without any involvement from an operator. The technology utilizes a CO2 sensor that is a universal detector of aerobic bacteria and yeast & mold metabolism (Remember the Kreb’s cycle? Part of this metabolic pathway involves the conversion of carbohydrates, fats, and proteins into water, CO2 and energy).

The PET procedure utilized allows for an easy estimate of the initial inoculum with a single ready-to-use vial that can replace multiple plates. After the product interaction with inoculated product, the system automatically calculates if the appropriate reduction in numbers of organisms was achieved.

The system is fully automated including: data archiving, data maintenance in databases, and automatic report generation. Create a paperless laboratory with centralized test data automatically stored and protected, and software that is 21 CFR Part 11 compliant. Increase efficiency and savings on disposables (no need for decimal dilutions), time and space, and best of all the system is unaffected by product interference. BioLumix streamlines microbiological testing delivering a simpler, faster, and automated solution saving your company significant time, labor and money.

BioLumix offers a comprehensive range of tests for raw ingredients and finished products, as well as processing water and environmental testing.

Cosmetic Science Symposium & Expo

The Science Symposium is organized by the Personal Care Product council and attracts more than 300 industry leaders and decision-makers while offering the personal care products industry staff one-stop shopping for information about Microbiology, Quality Assurance, Safety, and Environmental.

Free Product Trial

Give us your most difficult samples and we will test them for free. We will provide you with a detailed
report which includes a side-by-side comparison to USP methodology to the BioLumix method. The data
generated is strictly confidential and is only used to help validate the system for your company should
you decide to purchase.

We look forward to working with you and earning another satisfied customer! Please call us at 734.983.3100

*The BioLumix System has been validated against USP chapters <61> and <62>, using USP <1223> as the guideline for validation. It has not been validated for PET.

Posted in BioLumix Blog, Cosmetic, PET | Comments Off

BioLumix to Exhibit its Rapid Automated Microbiology System for Pharmaceutical Testing

October 4th, 2011

BioLumix will be exhibiting at the PDA’s 6th Annual Global Conference on Pharmaceutical Microbiology held at the Marriott Bethesda North Hotel & Conference Center October 17th and 18th. Please come by the BioLumix exhibit (booth #19) and see how we are innovating and streamlining microbial testing for the Pharmaceutical Industry.  Our Rapid Microbiological Method (RMM) will simplify and accelerate the testing process with all assays completed on a single platform.  The automated BioLumix System provides real-time communication for immediate action; most completed assay results in 12-18 hrs – Yeast and Mold within 48 hrs.

A poster entitled: “Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count“  describing the scientific data behind the BioLumix technology and its validation is being presented.  The poster will show a technology overview and validation case studies for the BioLumix System, the new RMM technology that is capable of simultaneously detecting microbial growth, providing an estimation of viable cell counts, and identifying the presence of specific microorganisms, using a novel and automated growth-based format is presented. The case studies demonstrate the ability of the technology to detect total aerobic microorganisms, total yeast and molds, and the presence of E. coli, Staphylococcus, Pseudomonas, Salmonella, as well as additional microorganisms.  The data shown in the study indicates that the BioLumix system can be used as a RMM with comparable results to USP <61>.   The method has good specificity in detecting target organisms and excluding non-target flora.  The detection limit for the BioLumix system equals or is slightly better that the limit for the plate count method. High precision or repeatability was obtained for all three assays tested.  The system is capable of performing multiple assays in a streamlined protocol

FDA’s Support and Encouragement of New Technologies

Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER stated that “FDA actively encourages use of new technologies including rapid microbiology methods” (RMM).  Drs. David Hussong and Robert Mello (New Drug Microbiology Staff at CDER) published a paper and stated the following: “New microbiology methods can offer advantages of speed and precision for solving microbiological problems associated with materials or environmental influences.  Neither Corporate economics nor regulatory attitudes should be a barrier to the use of new testing technologies or different measurement parameters.  In fact, if we are to increase our understanding of quality-based products and processes, then quality by design principles and risk analysis methods must be extended to the development of new microbiological technologies. This approach will drive process engineering to yield real, measurable gains in microbiological product quality assurance.”

The FDA has accepted the BioLumix Drug Master File (DMF):  The DMF is helpful for all Pharmaceutical companies producing prescription drugs.  The DMF is a technical document that contains support data for specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.  The DMF can be used to streamline the validation of the BioLumix system, saving companies that wish to adopt the technology time and money.  For over the counter drugs the documents can serve as the basis for the validation package.

The current validation package will allow OTC users to utilize the system immediately, since during the system installation all validation elements will be completed by our trainers and your microbiologists.

Fast Return on Investment

Streamlining your microbial testing with our reliable, easy-to-use system will save you time and money.   In most cases a very quick return on investment can be proved.  We invite you to contact us and inquire about our Return on Investment calculation.  We have shown in many cases the BioLumix System will pay for itself within the first 6 months of ownership. 

Hear What Our Customers Are Saying

Don’t just take our word for it, talk to our customers.  We have recently conducted a customer survey and are proud to share we have 100% customer satisfaction and that all of our customers would recommend the BioLumix.  Unanimously, our customers agree – the main features of the BioLumix system are:  Speed to results, simplicity of use, accuracy and clarity of data presentation. You are free to contact our customers to discuss their first hand experience.

Free Product Trial

Give us your most difficult samples and we will test them for free.  We will provide you with a detailed report which includes a side-by-side comparison to USP methodology along with a sample of the BioLumix 48 hour automated Certificate of Analysis.  The data generated is strictly confidential and is only used to help validate the system for your company should you decide to purchase.

Come to our booth #19 and speak to an expert or contact us directly (734-984-3100) to learn more about the exciting new developments at BioLumix; such as:  our space, time, labor and material saving technology, 48hr Certificate of Analysis, as well as our environmental monitoring and water testing solutions.

We look forward to working with you and earning another satisfied customer!

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Posted in BioLumix Blog, Nutraceutical, Pharmaceutical | No Comments »

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