Happy Holidays

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.

Microbiological testing of OILS

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.

A Novel Rapid Automated Method for Suitability Testing

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

Rapid Yeast and Mold Testing yielding Results in 48 hours

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) and Nutritional and Dietary supplement products (USP).

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

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


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!

Social Media: The Future

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.

For More Information, Check Out:

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

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.

BioLumix to Exhibit its Rapid Automated Microbiology System for Pharmaceutical Testing

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!

Are cGMP Regulations driving up your Costs? Find out how to reduce your Microbiological testing Costs

For answers Visit BioLumix at booth 21017 @ SupplySide West 2011 in Las Vegas

Since the completion of implementation of the cGMP’s for Nutraceutical Companies, 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 organism such as Salmonella, E. coli, and sometimes S. aureus).  The state of the art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP. The System is designed to accelerate product release with a simplified, automated approach. This yields fast, accurate, real-time results while reducing costs.  No more waiting days for completed assays. 

The streamlined all-in-one system is capable of testing raw materials, finished product, environmental swabs and processing water, all on a single platform.  Additionally, the system offers simplified sample preparation, real-time communication and a complete automated Certificate of Analysis, including the completion of all assays in 48 hours.   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.  A sample Validation book will be available for viewing while visiting the BioLumix booth during SupplySide West 2011.

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 Advantage: 

-          All assays can be performed on one Automated Microbial testing system

-          Automated Certificate of Analysis within 48 hours including results of all assays

-          Can be operated by non-Microbiologist

-          Complies with FDA cGMP Regulations

-          System is fully Validated during system installation

-          Designed to accelerate product release

-          Fully automated data archiving

You can find BioLumix on social media pages Linked In, Twitter and Facebook.  Follow us, become a Fan or join a discussion on one of our pages.

October 2011 marks the 5th year of BioLumix to exhibit at SupplySide West in Las Vegas, NV.  This yearly convention is held at the Sands Expo Center in The Venetian Hotel & Casino.  The Exhibit show hall will open beginning Wednesday, October 12th from 10am – 5:30pm, and Thursday, October 13th from 10am – 5pm.  BioLumix will be exhibiting in booth #21017.  Be sure to stop by booth #21017 to inquire about our free product trial and current Show Special! Pick up literature or leave your contact information to find out more about how the system can help your company save.

Come and See us at the Natural Products Expo East in Baltimore September 22nd – 24th

This marks our first year exhibiting at the Natural Products Expo East trade show located this year at the Baltimore Convention Center September 22nd – 24th; and thanks to the growing BioLumix customer base we are rapidly becoming a recognizable solution to today’s cGMP microbial requirements.  I wanted to take this opportunity to invite you to our exhibit (booth #4627) at the show and express what’s new at BioLumix.

We have 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. 

Currently, the majority of our clients are manufacturers of Nutraceutical and Dietary Supplements. In the past year we have doubled our customer base, many of which are recognizable names in the industry who will also be exhibiting at this year’s Natural Products Expo East. 

In addition to the Nutraceutical Industry, we offer microbial testing solutions to the Pharma – OTC, Cosmetic, and Dairy Industries.  Come to our booth (#4627) or contact us directly (734-984-3100) to learn more about the exciting new developments at BioLumix; such as:  our environmental monitoring and water testing solutions, as well as our labor and material saving Preservative Efficacy Test (PET).   

Fast Return On Investment

An automated Certificate of Analysis is generated in just 48 hours!  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 most 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.

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

Come and See Us at the International Dairy Show 2011 in Atlanta, GA September 19th – 21st

For the first time BioLumix will be exhibiting at this year’s International Dairy Show in Atlanta, GA.  In the last three of years, BioLumix has established itself as a leader of innovation in Rapid Microbiological Methods.  With our breakthrough technology we have found tremendous success in rapid microbiological testing, selling over 200 instruments.  We would like to invite you to our booth (#1816) to demonstrate our instrument, ready-to-use vials and discuss how the system may benefit you.

Traditional methods are slow, tedious, labor intensive, and often not suitable for assessing the quality and shelf-life of perishable dairy products.  BioLumix can make the microbiological testing simpler, faster, and automated – saving your company time, labor and money. We offer a comprehensive range of microbiological tests for raw ingredients and finished products, as well as processing water and environmental testing.

The BioLumix system is designed to accelerate product release with a simplified, automated approach. This yields fast, accurate, real-time results while reducing costs. No more waiting for days for completed assays.  We offer real-time results of contaminated samples saving hours, possibly days. Completed Coliform or Enterobacteriaceae results are available within 8-12 hours; Yeast and Mold results within 48 hours. BioLumix will streamline and simplify the microbiological procedures, save labor and create a paperless laboratory, while generating results that correlate well with plate count methodology.

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, the microbiologist’s job got a lot easier with the same accurate results in less than half the time.  See our innovative vial design which prevents product interference even when directly testing products such as yogurt and other cultured dairy.  Come to our booth (#1816) or contact us directly (734-984-3100) to learn more about our 12 hour Coliform assay, our 48 Yeast and Mold assay, and direct sample introduction = no dilutions.  

The BioLumix Advantage

• Vial design prevents product interference

• Automation and connectivity allows faster product release

• Real-time communication for immediate action

• Expedited results: coliform and Enterobacteriaceae results within 12 hours; Yeast and mold assay in 48 hours

• Early warning of contaminated samples

• No decimal dilutions required – direct sample introduction to vials

• Reduced risk of microbial contamination

• Automated data archiving and audit trail

• Streamlined testing increases laboratory efficiencies

• Paperless laboratory: centralized test data automatically stored and protected

• Barcode capability for automated sample entry

• Environmental testing made easy

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 that 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. Please 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 your current manual methodology.  The data generated is strictly confidential and is only used to show the high correlation of results should your company decide to purchase.

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

Rapid Coliform, Yeast and Mold Testing of Yogurt

Testing of Yogurt and Other Dairy Products

Yogurt is a dairy product, which is made by blending fermented milk with various ingredients that provide flavor and color.  Manufacturers have responded to the growth in the yogurt market by introducing many different types of yogurt including low fat and no-fat, creamy, bio-yogurt, organic, baby, and frozen.  The popularity of yogurt has increased due to its perceived health benefit resulting in significant increase in consumption (Chandan et. al 2006) as shown in Figure.

Recently Reuters reported that Dannon, the world’s largest yogurt maker, announced that it expects annual double digit percentage dairy sales growth in the United States over the long term.

Microbiological Testing of Yogurt

Undesirable microorganisms constitute the primary hazard to safety, quality, and wholesomeness of milk and dairy foods.   The primary assays performed in yogurt are yeast and mold (requiring up to 7 days for results) and the coliform assay that is used as an indication of appropriate processing. Traditional methods are slow, tedious, labor intensive, and often not suitable for assessing the quality and shelf-life of perishable dairy products. 

 The emphasis on the programs based on HACCP (Hazard Analysis and Critical Control Points) for total quality management in the dairy industry and increased demand for microbiological surveillance of products, process, and environment have led to increased interest in rapid methods and automation in microbiology.

BioLumix technology can make the microbiological testing simpler, faster, and automated.  Saving time, labor and money. 

The BioLumix test method for detection of coliform and yeast & molds involves a direct addition of the sample into ready to use vials and automated monitoring of the samples in the instrument.  The coliform assay is completed in 12 hours, while most contaminated samples are flagged within a typical shift.  The yeast & molds assay is completed in 48 hours as compared to the 5 days required for the standard assay.

The ready–to-use vials come with media that is pre-adjusted for pH, such that after the addition of the sample the appropriate pH for the growth of the microorganisms is attained.  BioLumix has developed such a media that is custom made with a higher pH to accommodate the low pH of yogurt while still maintaining the capability to test as much as 1.0 gram of product directly in the vials.    

Coliform Assay:

The curves obtained by the addition of 1.0 gram of yogurt to a high pH vial (pH 8.2) of coliform are shown:

The Dark Blue curve shows the 1.0 gram sample.  All product interference has been eliminated as depicted by the flat part of the curve.  The Green Curve illustrates a yogurt sample inoculated with a coliform.




In North America, BioLumix has tested yogurt samples manufactured by a number of companies.  The Table below includes a series of products from one such company Yoplait, Ontario, Canada.  These samples include low fat and regular varieties. 

Lemon Cream Pie Light Fat Free
Key Lime Pie Original 99% Fat Free
Strawberry Shortcake Light Fat Free
Raspberry Mousse Whips
Strawberry Thick & Creamy Low Fat
Key Lime Pie Original
Delights Parfait Chocolate Raspberry

All un-inoculated products resulted in flat curves as seen in the Figure.  Product interference was not found.

All products tested were shown to be clean (<1 coliform/ gram).  All inoculated products detected in the system in less than 8 hours.

Yeast and Mold Assay:
Similar results were obtained for yeast and molds. The curves show the results obtained with a variety of yogurt products.

Fieldberry Stirred Yogurt Dark blue
Raspberry Stirred Yogurt Green
Raspberry Stirred Yogurt-inoc CAD L- blue
Yoplait Mingo Red
Yoplait Mingo-inoc ASP Purple
Tubes- Raspberry Yellow
Tubes- Grapes Tan
Irresistible Creamy yogurt Vanilla Dark green

The inoculated samples (light blue- inoculated with Candida albicans; purple inoculated with Aspergillus niger) detected in less than 24 hours.  All the un-inoculated samples were clean and did not detect in the vials.  A total of 50 different yogurts were tested using this method and the data showed that all the samples that contained either yeast or mold detected in the system and none of the clean samples detected.  The plate count results agreed 100% with the BioLumix vial results.

Conclusion:

The BioLumix system is designed to accelerate product release with a simplified, automated approach. This yields fast, accurate, real-time results while reducing costs. The BioLumix offers real-time results of contaminated samples saving hours, possibly days. Completed Coliform or Enterobacteriaceae results are obtained within 12 hours; Yeast and Mold results are obtained within 48 hours.

References:

R.C. Chandan, C.H. White, A. Kilara, and Y.H. Hui. 2006. in Manufacturing Yogurt and Fermented Milks. Blackwell Publishing.

Rapid Microbiological Testing of Capsules, Softgels and Pills Encapsulation of Pharmaceuticals

Pharmaceutical products may be encapsulated in a relatively stable shell for oral consumption.  These shells are called capsules and can either be hard-shelled or soft-shelled.  Hard-shell capsules are commonly filled with dry powdered ingredients, pellets, or granules.  Soft-shell capsules (softgels) are made from gelatin and primarily contain oils or active ingredients that are dissolved or suspended in oil.  Both hard and soft-shell capsules may contain colorants, dyes, opaquing, dispersing, or hardening agents, and preservatives.  Tablets are solid doses of medicinal substances and may be soluble effervescent, chewable, molded, or compressed.

Traditional methods for testing

Plate count methodology as described in USP <61> is regularly used to test capsules and tablets.  Using this methodology, it takes two days for Aerobic Count results, and five days for Yeast and Mold results.  When testing for objectionable organisms, it may take several days using selective broths or agars to determine the absence or presence of these bacteria.   The colors of the shells and the products and the viscosity of the 1:10 dilution sometimes interfere with the reading of the plates.

Rapid Detection with the BioLumix System

The BioLumix System simplifies testing, expedites time to results, reduces the testing cost and accelerates product release while providing better control of microbial contamination.  The system can be used to automate microbial testing with a more cost effective and streamline manner, and reduces the error rates produced by paper-based activity recording and batch data entry.  The BioLumix system also helps automate microbiological quality control processes.

To validate the equivalency of the BioLumix system to USP <61> or USP <2021>, over 100 types of capsules, softgels, and tablets were tested with the BioLumix system and plate count methodology at various specified levels.  The products were tested for total aerobic microbial count (TAMC), Total yeast and mold count (TYMC), and the absence of E. coli, P. aeruginosa, S. aureus, and Salmonella (objectionable organisms) in 10 grams of product.  For each assay, a 1:10 dilution was created by adding 10 grams of product to 90 mL of TSB and further dilutions were performed depending on the desired specified level.  Some of the samples were inoculated with various bacteria.


Figure 1 shows the BioLumix curves obtained for the Total Aerobic assay.  The purple curve represents an inoculated colored capsule.  All the curves along the baseline represent different kind of capsules that were not contaminated.


Figure 2 shows the BioLumix curves for the Yeast and Mold assay.  The dark blue curve represents an inoculated product. All the curves along the baseline represent different kind of capsules that were not contaminated.

 

As seen in Figure 3, the BioLumix vial design is separated into two zones: the incubation zone where the sample is present and the detection zone where the reading takes place.  Therefore, the system prevents any product interference.

Figure 3 shows two vials that contained dissolved blue capsules.  The sample on the right contained bacteria while the sample on the left was clean.

Final results are seen in the BioLumix system roughly 25-40 hours faster than the plate count method in the Total Aerobic Count assay and 40-72 hours faster in the Yeast and Mold assay.

When testing for objectionable organisms, results may be obtained several days sooner than the plate count method.  Following the BioLumix protocol, 0.1 mL of the incubated sample in TSB is added to a selective vial and data is collected in the BioLumix instrument for 18-24 hours, depending on the assay.  If detection occurs, the sample may be verified with a confirmation assay.  This procedure eliminates hours or days waiting for plate results.

The BioLumix system is faster, less labor-intensive, and more sensitive than the plate count method.  With an automated certificate of analysis generated within 48 hours, the time-to-results is reduced and allows for quick release of products.

Caron Ockerman

References:

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

USP <2021> MICROBIAL ENUMERATION TESTS—NUTRITIONAL AND DIETARY SUPPLEMENTS

USP <2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS 

New Bacillus Cereus Vial for BioLumix

Bacillus cereus…

Bacillus cereus is a Gram-positive, facultatively aerobic spore former whose cells are large rods and with spores that do not swell the sporangium.  B. cereus spores are more resistant to heat and chemical treatments than vegetative pathogens such as Salmonella, and E. coli.

Bacillus cereus is responsible for 5% of foodborne illnesses worldwide, causing severe nausea, vomiting and diarrhea. Detecting potential B. cereus as quickly and easily as possible is of paramount importance. B. cereus food poisoning has two recognized types of illness are caused by two distinct metabolites. The diarrheal type of illness is caused by a large molecular weight protein, while the vomiting (emetic) type of illness is believed to be caused by a low molecular weight, heat-stable peptide.

The symptoms of B. cereus diarrheal type food poisoning include watery diarrhea, abdominal cramps, and pain occurs 6-15 hours after consumption of contaminated food. Nausea may accompany diarrhea, but vomiting rarely occurs. Symptoms persist for 24 hours in most instances. The emetic type of food poisoning is characterized by nausea and vomiting within 0.5 to 6 h after consumption of contaminated foods. Occasionally, abdominal cramps and/or diarrhea may also occur. Duration of symptoms is generally less than 24 h.

A wide variety of foods including meats, milk, vegetables, and fish have been associated with the diarrheal type food poisoning. The vomiting-type outbreaks have generally been associated with rice products; however, other starchy foods such as potato, pasta and cheese products have also been implicated. Food mixtures such as sauces, puddings, soups, casseroles, pastries, and salads have frequently been incriminated in food poisoning outbreaks.

Two different methods are described in BAM1 for the detection of B. cereus: (i) plate count method with Mannitol–Egg Yolk–Polymyxin (MYP) agar and (ii) a Most Probable-Number (MPN) method with Tryptic Soy Broth (TSB) supplemented with 0.1% Polymyxin Sulfate.  The MPN method allowed for better recovery and therefore for higher counts than MYP2, probably due to the better ability of the broth to recover injured organisms.

BioLumix Vial:

A new vial (BCP) was developed specifically for B. cereus detection in the BioLumix system.  It uses the CO2 sensor at the bottom of the vial.  The medium contains growth promoting ingredients peptones, casein digest and Yeast Extract. Sodium Pyruvate is added to facilitate the resuscitation of damaged Bacillus cells. Manganese Chloride is added to aid the germination of spores.  Inhibitors include Cyclohexamide to prevent growth of YM; LiCl, Cyclohexamide and Polymixin B are used as inhibitors.

                                    ATCC 10876- Dark Blue; ATCC 11778- Green; ATCC 14549- Light blue; and ATCC13061-Red

 Twenty five cultures of gram negative organisms and Twenty one cultures of gram positive organisms were tested in the BC vial.  None of the gram negative organisms grew in the vial and all gram positive organisms did not grow except one strain of Enterococcus feacalis (ATCC 19433). The new BC vial recovers well vegetative cells as well as spores. The method used is very simple, just pipette the diluted sample into the vial.  The results are obtained in 24 hours or less.  This vial is ready for free product trials.

References:

  1. E. Jeffery Rhodehamel and Stanley M. Harmon (2001). Bacteriological Analytical Manual, Chapter 14: Bacillus cereus (2001). US Food and Drug Administration.
  2. N. M. Harper, K.. K. Getty, K. A. Schmidt, A. L. Nutsch, and R. H. Linton. Comparing the Mannitol–Egg Yolk–Polymyxin Agar Plating Method with the Three-Tube Most-Probable-Number Method for Enumeration of Bacillus cereus Spores in Raw and High-Temperature, Short-Time Pasteurized Milk. J. Food Prot.71:473–478.

Come and See us at the 100th Anniversary of the IAFP in Milwaukee, WI July 31st – Aug 3rd

This marks our fourth year exhibiting at the IAFP trade show and thanks to our growing customer base we are rapidly becoming a recognizable Rapid Microbiological Method in the Food and Dairy Industries.  I wanted to take this opportunity to invite you to our exhibit (booth #400) at the show and express what’s new at BioLumix.

We continue to innovate, growing our assay repertoire and capabilities – allowing you to perform all required assays on raw ingredients, finished products, as well as test environmental samples and processing water.  With automated monitoring of ready-to-use assay vials and automated data processing and archiving, the microbiologist’s job got a lot easier with the same accurate results in less than half the time.  Our innovative vial design prevents product interference even when directly testing products such as yogurt and salad dressing.  Come to our booth (#400) or contact us directly (734-984-3100) to learn more about the exciting new developments we are featuring at this year’s IAFP:  our Bacillus cereus assay, Heterotrophic Bacteria in water along with our environmental monitoring solutions.   

The BioLumix Advantage

• Vial design prevents product interference

• Automation and connectivity allows faster product release

• Real-time communication for immediate action

• Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours

• Early warning of contaminated samples

• No decimal dilutions required – direct sample introduction to vials

• Reduced risk of microbial contamination

• Automated data archiving and audit trail

• Streamlined testing increases laboratory efficiencies

• Paperless laboratory: centralized test data automatically stored and protected

• Barcode capability for automated sample entry

• Environmental testing made easy

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 your current manual methodology.  The data generated is strictly confidential and is only used to show the high correlation of results should your company decide to purchase.

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

Pet Food and Microbiology

Why is it important to test Pet Food for microbiology?

In the past few years there have been multiple outbreaks related to pet food affecting the health of both pets and humans.  Most people associate Salmonella as a bacterium linked to food borne illness in people food, but in recent years there have been quite a few outbreaks of Salmonella in pet food that has also affected humans.  The most concerning aspect is that it primarily caused illness in small children.  It was not believed to be caused by the children eating the dog food, but having interactions with the dog.  After it was discovered that the outbreak was caused by tainted dog food, over 23,000 tons of pet food was recalled, and when the outbreak continued, the plant that produced the tainted dog food was closed down.  There was also a pet food recall based on an aflatoxin contamination.  The Center for Disease Control (CDC) categorizes aflatoxin as a naturally occurring fungal toxin that contaminates maize and other types of crops during production, harvest storage or processing1.  The aflatoxin outbreak was linked to the death of over a hundred pets.  In the past year Kroger stores recalled a wide variety of pet foods due to a possible contamination caused by aflatoxin2.

However, it is more effective to test for indicator organisms rather than to test for pathogens such as Salmonella.  Indicator organisms are used to measure potential fecal contamination of environmental samples. The presence of coliform bacteria, such as E. coli, is a common indicator of fecal contamination. Indicator organisms are typically used to demonstrate the potential presence or absence of groups of pathogens. The use of indicators is attractive because it reduces the complexity and cost of analyzing

Indicator microbes are generally selected for the following reasons:

1) They are initially abundant in the matrix to be assayed.

2) A relatively rapid, accurate, and cost effective analytical method for enumerating the indicator exists or can be readily developed.

3) A reasonably strong correlation exists between the presence/absence of the indicator and a particular pathogen or group of pathogens. The strength of the correlation will determine the effectiveness and accuracy of the indicator as a measure of pathogen occurrence.

In pet food testing is conducted for Enterobacteriaceae or fecal coliform as indicator of fecal contamination and yeast and mold as indicators for general quality and aflaxoins.

What are the advantages of the BioLumix system?

Using the BioLumix system will allow the customers to test their products not only for Salmonella and yeast/molds, but also for indicator organisms such as coliforms, fecal coliforms, Enterobacteriaceae and more.  Indicator organisms can be used to pet food manufacturing to cleanliness and sanitary issues within the facility.  Also the presence of the organisms can affect appearance, taste and texture of the pet food.  The BioLumix system can save time when testing pet food products for Yeast and Mold, instead of taking five days using traditional plates, the BioLumix system will give the same results in under 48 hours.  This can help the manufacturers to avoid a potential aflatoxin contamination by knowing if their product contains any amount of mold.  Detecting fecal coliforms is even faster and saves even more money using the BioLumix system.  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.  Finally, the last confirmation step is to streak the positive EC Media to L-EMB agar plates; the BioLumix system instead requires one test vial and 1ml of the sample in order to detect a level as low at <10 cfu/gram, and can give results in under 24 hours.  Similarly, the Enterobacteriaceae test in BioLumix requires one vial instead of multiple MPN tubes required by the European method.

BioLumix Pet Food Study

BioLumix recently conducted a study of different store bought pet foods, ranging from dry dog food samples to wet (oil based) samples.  All samples matched the results for Yeast/Mold, Enterobacteriaceae, Total Aerobic Count, E. coli and fecal coliforms when comparing between the BioLumix System and traditional plating methods.  Since there are no specifications by AAFO or FDA for indicator organisms in pet foods the levels tested for Enterobacteriaceae were based on European standards for pet food.   The products were processed and tested using FDA-BAM methods3.  Only one sample came up positive for fecal coliforms, results of the BioLumix vial matched the MPN results.  Two of the samples had counts >10 cfu/g for Enterobacteriaceae and were the only ones that were above the specification level of cfu’s of the manufacturer. 

The BioLumix system detects optical changes in the test vial, presenting results of the assays as soon as detections occur with no need for involvement of an operator or a microbiologist, providing significant savings on laboratory labor. Any out-of-spec samples are flagged in red, demanding attention. The greater the contamination level, the faster the result, ensuring a rapid warning of poor-quality raw materials, finished products or any equipment line issues.

The BioLumix System showed a high correlation between the instrument results and the BAM methodology.  It simplified the microbiological testing, offers a significant reduction in time to obtain results and reduces hands-on labor due to its automation and simplicity of use.  The time to results for bacteria was hours rather than days while yeast and mold required only 48 hours instead of 5 days. 

  1.  http://www.cdc.gov/nceh/hsb/aflatoxin/
  2. http://www.prnewswire.com/news-releases/kroger-recalls-pet-foods-due-to-possible-health-risk-112125284.html
  3. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm

Dilute-to-Spec. What is it? And, why use it?

Plate Counting

Historically, microbiological methods to enumerate bacteria, yeast or mold include conducting decimal dilutions of a sample, mixing the decimal dilutions with molten agar (semi-solid) into Petri Plates and allowing for microorganisms to replicate and appear as colonies.  The Colony Forming Units (CFU) can then be enumerated and the amount of the microorganisms in the sample can be estimated. 

The plate count method is based upon two major assumptions: (i) that every cell forms one colony and (II) that every colony originates from one cell.  Neither assumption is accurate.

  1. Each cell form a colony: The ability of a given cell to form a colony depends upon a myriad of factors, including the physiological state of the cell, the medium used, the incubation temperature, oxygen, etc. as well as previous treatment of the cells (cell injury). 
  2. Each colony originates from a single cell: this may not be true if pairs, chains, or clumps of cells are not completely broken apart before plating.  Mixing, shaking or other procedures cannot assure that all cells are separated.

“With all the errors and assumptions, the plate count may represent somewhere between 10% and 90% of the real number of bacteria present in the sample” (Banwart, 1981).  The main value of a plate count is the ability to compare the results.

After incubation, plates with 30-300 (USP) colonies per standard-sized plate are counted (Bacteriological Analytical Manual (BAM) uses 25-250 colonies to be counted on a plate).  This number of colonies (30-300) was chosen because the number counted is high enough to have statistical accuracy, yet low enough to avoid nutrient competition among the developing colonies.  This theoretically mean that any specified level below 250 cfu/g (1:10 dilution x 25 colonies = 250) cannot be accurately counted by the plate count method.  Otherwise, recording a CFU of “less than,” or too numerous to count (TNTC) (Yousef, 2003 p. 7-11) must be followed. Typically, plate methods take 2 – 5 days to incubate before the results are available.

Dilute-to-Spec

Dilute to spec is a different approach to enumeration of bacteria in a sample.  The Dilute-to-Specification protocols require diluting the sample to the specification limit required for product action or release. If there is growth, the sample fails; if there is no detection, the sample passes since the counts are below the specification limit. If we use an example of a specification level of <10 cfu/g, and assume that one organisms can detect in the vial. If there is a detection after adding one ml of a 1:10 dilution then there are counts >10cfu/g, and if there is no DT it means <10cfu/g.  For a spec. level of <100 cfu/g, 0.1 ml needs to be added to the vial.  For higher spec levels we just add more dilutions.  The following equation can be used to calculate the required dilution:

1/spec level=dilution * amount to vial

For example if we use a specified level of 500 cfu/g the required dilution is 1/500=0.002:

–        Dilute 1:100

–        Add 0.2 ml to a vial

–        1:100=0.01; 0.01*0.2=0.002

After the appropriate dilution if the sample does not have a DT it means that the count is <500 cfu/g.  If there is a DT the count is >500 cfu/g.

The dilute to spec. approach correlates well with the plate count methodology while yielding a clear cut distinction between samples above and below spec.

Protocols were developed for raw materials, finished products, and environmental swabs as well as processed water.  The system automated reporting system collates the data from all these assays to generate a single report.

Multi Assay Protocol

The figure below shows an example of a flow chart for performing multiple assays.  A streamlined protocol was developed allowing the analysis of tablets, capsules, suppositories, and liquid material.

In this example the specified level for yeast and mold is <1,000 cfu/g.  A 1:10 dilution of the product in TSB is followed by a 1:100 dilution in buffer.  1.0 ml is transferred to a yeast and mold vial (shown in yellow in the figure).  The total dilution is 1:1,000, therefore if there is growth in the vial resulting in a DT, the vial contains yeast and mold >1,000 cfu/ml.  A flat curve without a DT indicates that the sample has <1,000 cfu/g. 

Absence of specific organisms, such as E. coli, S. aureus, and Salmonella is determined by pre-incubating 10.0 grams of sample in TSB for 18 hours followed by the distribution of the pre-incubated broth into the appropriate vials. 

Four hundred thirty-seven dietary supplement and OTC samples were analyzed for total aerobic count at various specification levels.  Therefore, there was 99.8% agreement between the USP plate count method and the BioLumix dilute-to-spec method. This indicates the ability of the BioLumix system to yield equivalent results to the plate count method over the range of 100 cfu/g to 10,000,000 cfu/g.  Similar results were obtained for yeast and mold counts and Gram Negative Bile Tolerant bacteria.

Why Use it?

The dilute to spec approach allow automating the assays, streamlining and simplifying the procedures, save labor and create a paperless laboratory, while generating results that correlate well with the plate count methodology.

 

References:

Banwart, G. 1981. Basic Food Microbiology. AVI Publishing Company Westport, CT.

Yousef, A., and Carlstrom, C (2003).  Food Microbiology: A Laboratory Manual. Hoboken, NJ: John Wiley & Sons, Inc.

USP <2021> Microbial Enumeration Tests-Nutritional and Dietary Supplements

USP <61> Microbial Examination of Nonsterile Products: Enumeration Tests

Bacteriological Analytical Manual (BAM) 8th Edition (1981)

BioLumix DMF Submission for Rapid Microbiological System Accepted by FDA

Ann Arbor, MI, May 20, 2011: BioLumix announced today that the US Food and Drug Administration (FDA) have accepted a BioLumix Drug Master File (DMF) entitled “Microbiological Rapid Method for the Detection and Enumeration of Microorganisms in Pharmaceutical Products”.  The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs. 

Dr. Ruth Eden, President of BioLumix said, “The DMF can be referenced by drug manufacturers, reducing FDA review times and accelerating the regulatory approval process for use of the BioLumix System.  In addition, Over the Counter (OTC) products can be tested in conjunction with the BioLumix Validation Package.  The BioLumix DMF includes the information the FDA requires to assess alternative microbiological detection systems; such as, information about the technology, its accuracy, specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.”

“FDA actively encourages use of new technologies including rapid microbiology methods (RMM)” stated Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER.  Newer microbiological methods can improve company’s’ quality of testing and result in significant financial savings.  Such methods can reduce cycle times resulting in a leaner and more responsive supply chain. 

“The BioLumix System is extremely easy to operate,  with its straightforward, streamlined testing design it offers  rapid, accurate results leading to reduced material-holding time for faster product release. “ said Kevin LaBrecque, Director of sales and Marketing at BioLumix. He continued, “It offers simplified single-platform testing for all assays with a 48-hour Automated Certificate of Analysis, while avoiding any product interference.”

ABOUT THE BioLumix DMF: In the DMF BioLumix shares specific technical and regulatory information with the FDA, including details about reagent composition, mode of action of reagents and growth media, and performance characteristics of its system. The FDA will be able to evaluate the use of the BioLumix system in pharmaceutical applications for rapid detection of microorganisms, when referenced by the customer.

ABOUT BioLumix:  BioLumix provides microbial testing products for the rapid detection of microorganisms to the Pharmaceutical, Nutraceutical, Dietary Supplements, Cosmetics, Toiletry and the Food Industries. Using an internally developed proprietary advanced technology a wide variety of test kits are available covering all required microbiological assays. By reducing microbial testing time and consequently, time for product release, the BioLumix system increases testing efficiency, manufacturing productivity and improves supply chain management.

BioLumix Customer Satisfaction Survey

At BioLumix customer satisfaction is our #1 priority!  We are in the “service” business and customer satisfaction is essential to not only our growth but, our survival.  We strive every day to meet and exceed our customers’ expectations.  During the past year we have doubled our customer base.   As with most companies that enjoy this type of fast pasted growth there is always the chance for service to slide.  We needed to measure whether we are still holding true to our #1 priority; so, we recently conducted a ‘Customer Satisfaction Survey’ to measure our development.  Below are the highlights from the survey:

How satisfied are you with the BioLumix company overall?

We are especially proud to declare we received 100% customer satisfaction feedback!  Here are a few quotes from the comment section:

 “I think BioLumix is a great company, and continues to grow and expand in their rapid testing abilities” – Portia Bennett, Robinson Pharma.

They’re always there to help. They always answer all my questions and give good advice” – Karem Villegas, Self Health (Dr.ClarkStore.com)

 What do you like most about your BioLumix system?

 “Speed and clarity” – Mike Uckele, Uckele Health and Nutrition.   “The ability to conduct all microbial testing from a single sample in-house” – Kevin Ruff, ESM.  “It’s fast, easy-to-use, and accurate” – Karem Villegas, Self Health.  “Processing time” – Vanessa Valesco, Florida Supplements.  Speed of Analysis, and Easy to operate” – Ramiro Salgado, Formulation Technology.  “Ease of operation. I’m not a chemist. My technicians love it too” – Kenneth W. Engel, Herbal Extracts Plus.  “REDUCTION IN CYCLE TIME.” – Rich Connor, IVC.  “Simplicity of use” – Jeff Raber, The Werc Shop.   “Fast Turnaround time” – Michelle Manning, Formulation Technology.  “Ease of use for technicians and durability” – Nick Labinsky, Premier Research Labs.  “Simplicity” – Jim Paul, All American Pharmaceutical. “It is very easy to understand” – Christine Lawson, Formulation Technology.  “It’s easy to operate” – Vanessa Liu, Essential Pharmaceutical. “Product and customer service” – Sarah Serano, Avema Pharma Solutions.  “Its user friendly” – Krysta Hudson, Uckele Health and Nutrition.  “I like the speedy results and the immediate notification as soon as it detects a positive result” – Portia Bennett, Robinson Pharma.

How satisfied are you with the performance of your BioLumix System?

Again, we received 100% customer satisfaction feedback!  Comments included:

 “I like the breadth of abilities of the system and its ability to screen for pathogens” Dr. Jeff Raber – The Werc Shop.  “It’s been an easy, efficient, quick and practical way for us to test our raw materials, finished products and surfaces.”  Karem Villegas – Self Health (Dr.ClarkStore.com)

How satisfied are you with the technical service you receive?

Another 100% customer satisfaction response.  Some of the customer’s comments included: “My questions are answered in record time” – Kenneth W. Engel, Herbal Extracts Plus. All of the people at Biolumix have been very helpful in attending my technical questions” – Christine Lawson, Formulation Technology.

“Any questions I have ever had about BioLumix and BioLumix computer program have been answered immediately” – Portia Bennett, Robinson Pharma.

It was gratifying to learn that all our customers said that they would recommend the BioLumix system to their vendors, suppliers and customers!     - Ruth Eden, President, BioLumix, Inc.

Contact us today!  We would welcome the opportunity to earn another satisfied customer.

SupplySide East May 3-4, 2011 Come and See Our BioLumix Exhibit

Another year has passed and Spring is finally here!  Shortly following our successful show at Supply Expo Westin in Anaheim, CA, BioLumix will be traveling across the country to exhibit at the SupplySide East tradeshow in Secaucus, NJ.  The show floor is open beginning May 3rd and closes on May 4th.  Come and see (booth #1520) how we are revolutionizing the way companies are conducting their microbiology testing.  We would like to invite you to stop by and pick up some information, speak with experts and check out the newest most innovative technology on the market for Microbiology testing. 

When visiting our booth, be sure to:

-          See a demonstration of the system

-          Check out the 48-hour automated Certificate of Analysis

-          Let us help you Calculate your Return on Investment

-          Ask about our referral program

-          View the Validation Book

-          Pick up copies of Scientific White Papers

-          Find out more information about our technology

-          Contact us about the Free Product Trial!

-          Get references from our current customers

-          Hear about available financing options

-          Ask about the show special!

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 the 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.

We welcome all of our customers to stop by and say hello!  If you are not yet a customer, we would love 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 give you customer referrals.

Again, we would love to see you at the show and show you how our system can become a perfect fit for your company!

See you at Booth #1520!