BioLumix Exhibits @ SupplySide West 2012 – Stop by Booth # 33014!


SupplySide West 2012 will be held from November 7th until November 8th with over 12,000 attendees and 1,500+ booths. This year’s show brings together the suppliers and buyers that drive the dietary supplement, food, beverage, personal care and cosmetic marketplace. Leaders from the executive management, R&D, QA/QC and marketing teams will attend the meeting in Las Vegas. BioLumix R&D and executive team will be among them.

BioLumix offers an innovative microbiological testing solution designed specifically for the Nutraceutical and Dietary supplement industries. The system helps companies internalize microbial testing or make the existing microbial testing simpler, faster, and automated-saving the user significant time, labor, and money. The system can be used to perform all USP required assays on raw material, finished products, as well as complete testing for environmental samples and processing water. We have also expanded our offering to include the Pharmaceutical industry – OTC, Cosmetic, Food & Dairy Industries. The BioLumix system offers an Automated Certificate of Analysis within 48 hours for all USP assays, including total aerobic count, yeast and mold count, bile tolerant gram negatives and objectionable organisms (E. coli, S. aureus, Salmonella, etc.). The state-of-the-art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP regulations. With over 350 instruments performing assays daily we are confident the system will work for you.

We would like to take this opportunity to thank all of our current customers for their business and welcome all potential and current prospects to visit us at the show in Booth # 33014. BioLumix will be featuring the unique and versatile BioLumix system, so stop by and see what’s new!

BioLumix brochures will be available at Booth # 33014 or at the entrance of the hall. Be sure to visit our company profile using the SSW ’12 Mobile App! Download literature and video to watch a quick demo of the BioLumix System!

Try the system FREE by sending your own samples for testing! Pick your most difficult samples and BioLumix will test them complimentary. 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.

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 shown. 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.

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 – # 33014.

The BioLumix Advantage:

  • All USP assays available on a single platform
  • Can analyze tablets, capsules, powders, viscous material, without any product interference
  • Complies with FDA cGMP Regulations
  • Comprehensive and Complete Validation package = Successful Audit!
  • Designed to accelerate product release while saving resources
  • Real time communication & data archiving for peace of mind

PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology

PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology brings together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that the Pharmaceutical industry faces on a daily basis. This comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.

During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies, providing invaluable sessions dedicated to pharmaceutical microbiology, and a venue to network with fellow microbiologists, experts in all areas of pharmaceutical microbiology, key vendors of microbiology testing equipment & supplies, and regulatory/compliance professionals. Visit the BioLumix booth (#13) to learn about the most advanced rapid microbiological testing system.

BioLumix Offers Microbial Testing Solutions for the Pharmaceutical Industry BioLumix Rapid Microbiological Method is capable of performing testing equivalent to both USP <61>and <62> simultaneously on a single platform. The novel automated growth-based system simultaneously detects microbial growth, provides an estimation of viable cell counts, and identifies the presence of specified micro-organisms.

The automated, all-in-one microbial testing system is extremely easy to operate. The system is both simple and cost-effective, revolutionizing your current testing methodology. This novel optical system senses color and fluorescence changes in ready-to-use vials provides faster results, labor savings, automation, and connectivity. The streamlined testing design and rapid, accurate results lead to reduced material-holding time for faster product and raw materials release.

By encompassing both USP types of testing, the BioLumix is a complete screening solution making the existing microbial testing simpler, faster, and automated – saving your company significant time, labor and money.

DMF Submission and Validation The BioLumix Drug Master File (DMF) is on file with FDA. The BioLumix System is fully validatable! During the system installation we will generate the IQ (Installation Qualification), OQ (Operation Qualification), and will help you to complete the PQ (Performance Qualification) portion of the validation, leaving you with a complete validation package against USP <61> and <62>.

The BioLumix Advantage Quality Assurance with a Competitive Advantage – The Automated BioLumix System will accelerate your microbiological testing resulting in faster product release and decreased costs. The streamlined testing design reduces labor, time and supplies. The BioLumix software is 21 CFR Part 11 compliant with log-in, log-ofut and audit trail. It presents real-time communication for immediate action of contaminated samples and a 48 hour Certificate of Analysis for completed samples, as well as other customizable reports. Testing is non-destructive, allowing for further identification of organisms where needed. BioLumix offers a comprehensive range of microbiological tests for raw materials, in-process and finished products as well as processing water and environmental testing. The system can analyze tablets, capsules, powder, liquid and viscous material without any product interference.

BioLumix customer service is second to none, with the ability to offer customer support from anywhere in the world. With the BioLumix system, one can depend on receiving the most superior level of service, support and compliance with FDA regulations.

Please take the opportunity to speak with an expert about how the BioLumix System can help lower your testing costs. We invite you to visit our website at www.myBioLumix.com or send us your most difficult samples for testing. We at BioLumix truly believe we will make your company more efficient and add profit to your bottom line.

2012 Annual International Association of Food Protection

The 2012 Annual International Association of Food Protection is to be held in Providence, Rhode Island at the Rhode Island Convention Center July 22-25. The Annual Meeting has become the leading meeting concerned with the protection of the worldwide food supply and is attended by over 2,500 of the top industry, academic and government food safety professionals.

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Pseudomonads and Their Rapid Detection

Description of Pseudomonad Organisms

Pseudomonas bacteria (Pseudomonads) encompass gram negative, motile, non-fermenting rods. This genus is ubiquitous in nature and these organisms can impact a number of environments and patient populations. The Pseudomonads may be found in soil, on plant material, in water, and can be isolated from various tissues and body fluids from mammals. In human health, some of these organisms, primarily Pseudomonas aeruginosa, can be an opportunist pathogen and cause serious health problems. If allowed to reach unsafe levels, this organism may cause several health problems including skin rash and other skin infections, ear infection, urinary tract infection, and in rare instances, pneumonia. Other Pseudomonads, for example, P. stutzeri can be isolated from wounds but are generally not associated with human disease. Many Pseudomonads found in the soil can damage plant materials by causing spoilage.

Who tests for Pseudomonas and why?

Water Testing: Pseudomonas aeruginosa is a bacterium commonly found in purified water systems. Pseudomonas grows in water. It thrives at warm temperatures, which is why it is so often associated with spas. It can also grow in purified water systems.

Pharmaceutical and Cosmetic Products: Analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to September 2006 demonstrated that 48% of recalls were due to contamination by either Burkholderia cepacia, or Pseudomonas spp (Jimenez L. 2007). In cosmetic products, P. aeruginosa was recovered from contaminated mascara material and was identified as the agent responsible for corneal ulcers in the 1970s (Ortho 2009). Pseudomonads can survive and grow in DI water—Contaminated DI water may be the source of microbial contamination if it is used for the final rinse of equipment that has been cleaned and sanitized, and it may be the source of contamination for finished products in these industries.

Dairy and Food: The predominant microorganisms limiting the shelf life of processed fluid milk at 4°C are Pseudomonas spp. these species are able to grow to high numbers during refrigerated storage. Pseudomonas species accounted for79% of the psychotropic isolates that spoiled pasteurized milk (Dogan and Boor 2003). Important characteristics of Pseudomonads include their abilities to grow at low temperatures (3–7?C) and to hydrolyze and use large molecules of proteins and lipids for growth.

Biolumix Offers Two Options for Detecting Pseudomonads

For certain industries it is important to detect Pseudomonas aeruginosa, while for others it is important to detect all Pseudomonas spp, including the closely related Burkholderia cepacia. As a result BioLumix offers two different types of vials: the PSE vial for the detection of P. aeruginosa; and the PSB vial for the detection of all strains of Pseudomonas and for B. cepacia.

Detection of Pseudomonas aeruginosa (PSE Vial)

For the Pharma (OTC), Cosmetic and Nutraceutical Industries the primary cause for concern is the absence or presence of Pseudomonas aeruginosa. P. aeruginosa is common and is able to become an opportunistic pathogen in people and may cause severe disease (Hugh and Gilardi 1974). The ability to detect P. aeruginosa is critical in the non sterile Pharmaceutical products, Cosmetic and Nutraceutical Industries to ensure the product material is safe. BioLumix offers a highly selective media in the form of a test vial (PSE) that primarily only allows for the growth of Pseudomonas aeruginosa organisms. Confirmation of the presence of this organism is accomplished using the simple Oxidase reaction on vial contents. The test sample is merely enriched in TSB (Tryptic Soy Broth) per USP instructions and then tested directly in the BioLumix PSE vial. Other common Pseudomonads and closely related organisms, including B. cepacia and P putida, as examples, are excluded from growth due to the use of antibiotic supplements in the BioLumix PSE vial. P. aeruginosa is typically more antibiotic resistant than other Pseudomonas organisms (Blazevic, DL et al 1973). Figure 1 illustrates the growth curve of Pseudomonas aeruginosa ATCC 9027 in the BioLumix PSE vial.

KEY:Dark Blue Curve- P. aeruginosa Green Curve- Negative Control

Detection of other Pseudomonads (PSB Vial)

For many industries including the dairy industry and manufacturers using water, there is a need to test for all Pseudomonads as they impact these industries economically. Other Pseudomonads may include P. fluorescens, P. putida, and P. stutzeri. Burkholderia cepacia, can also be detected using the BioLumix PSE-B vial. Specific to the use of water in manufacturing: Pseudomonas bacteria can be found naturally in the ground and within drinking water sources such as aquifers. Contamination of either dairy products or water systems by Pseudomonads is something to avoid and early detection of goods using a rapid microbiological detection system such as the BioLumix Instrument System, would offer an advantage to the manufacturer. Figure 2 illustrates the growth of many types of Pseudomonads and Burkholderia cepacia in the BioLumix PSE-B vial.

KEY: Dark Blue Curve- B. cepacia; Green Curve -P aeruginosa; Light Blue Curve – P. putida; and Red Curve– P. fluorescens growth

REFERENCES

Blazevic, DJ, Koecke, M.H., and Mastsen J.M. (1973). Incidence and identification of Pseudomonas fluorescens and Pseudomonas putida in the clinical laboratory. Applied Microbiology 25: (1)

Dogan, B. and Boor, K J. (2003). Genetic diversity and spoilage potentials among Pseudomonas ssp. isolated from fluid milk products and dairy processing plants. Appl. Microbiol.,69: 130-138.

Hugh, R. and Gilardi, G. (1974) In “Manual of Clinical Microbiology” Edited by Spaulding, Lennette, Spaulding and Truant. Chapter 23 Pseudomonas.

Jimenez L.(2007). Microbial diversity in pharmaceutical product recalls and environments. Review. PDA J Pharm Sci Technol. 2007 Sep-Oct;61(5):383-99.

Ortho D. (2009). Insight into Cosmetic Microbiology, Chapter 8 263-267

Rapid Microbiological Testing of Osmophilic Yeast with the BioLumix Vial

Osmophilic or osmotolerant yeasts are able to grow in products containing high concentrations of organic solutes, particularly sugars. These organisms do not require a high water activity value and tolerate drier environments than non-osmotolerant organisms. Osmophilic yeast can cause spoilage of honey, corn syrup, jam, molasses,flavored syrups and toppings, and concentrated fruit juices. Many of the yeasts causing this spoilage belong to the genus Zygosaccharomyces. It is of great importance in the food industry to test for these organisms. Although no osmophilic organisms are highly pathogenic, they may cause food poisoning and opportunistic infections, especially in people with weakened immune systems.

Current Methodology

Although there are many techniques used to test and enumerate Osmophilic yeast, a standard method has not been attained. Different types of growth media have been suggested, but like the techniques, not one type of agar has been adopted as the standard. Using the plate count method, samples are blended with sterile phosphate buffer containing high concentration of glucose. Petri dishes are then inoculated with the appropriate dilution of the product, and agar medium that would promote growth of the Osmophilic yeast is added, depending on the type of product. Plates are incubated for 5-7 days. Membrane filtration technique can also be utilized to test the Osmophilic yeast. Typically, a 25-gram sample is added to the flask and mixed well with sterile distilled water. After filtration, provided that the product can be filtered, the walls of the flask and funnel are rinsed with the distilled water, and the filter placed on a desired growth medium and incubated for 5-7 days. Both the plate count and membrane filtration techniques pose threats to damaged organisms from general processing procedures, temperature of agar, and temperature, pressure and duration of incubation. Colonies may also be very small and difficult to count.

The BioLumix Osmophilic Yeast Vial

The BioLumix system provides Osmophilic Yeast results 3 days faster than the aforementioned methodologies. The Osmophilic Yeast vial has a CO2 sensor that is monitored by the yellow LED light in the BioLumix Instrument. This particular vial contains much more sugar than a typical Yeast and Mold vial, to allow only Osmophilic yeast to grow. The vial also contains Chloramphenicol to prevent the growth of bacteria.

The procedure to test for Osmophilic yeast is very simple; just add 10 grams of product to 90mL Tryptic Soy Broth or buffer, and add the appropriate amount to ready-to-use Osmophilic vials. For some product the sample can be added directly into the vial. From this 1:10 dilution, other dilutions can be made if necessary. From the appropriate dilution, 0.1 to 1.0 mL is added to the BioLumix vial. compared to the plate method. Figure 1 shows curves generated by the Zygosaccharomyces rouxii ATCC 34890 (blue) and 28253 (green). organisms while preventing product interference. It offers a reduced work load, faster time-to-results, and fewer costs associated with testing. The BioLumix system can make the microbiological testing simpler, faster and automated. The test runs for 48 hours, cutting the time-to-results by three days as The BioLumix system allows for selectivity of organisms while preventing product interference. It offers a reduced work load, faster time-to-results, and fewer costs associated with testing. The BioLumix system can make the microbiological testing simpler, faster and automated.

References:

Downes, Frances P., and Keith Ito. Microbiological Examination of Foods. 4th ed. Washington, DC: American Public Health Association, 2001.

Join us on Linked In

Did you know BioLumix has a Linked In group? If you’re interested in Rapid Microbiological Methods (RMMs) and like to stay up to date with current information, then please join us via the Linked In group: Rapid Microbiology Testing & Methods. This group brings together a unique group of people from all over the world that have one giant thing in common; they all have an interest in the BioLumix System: a rapid, automated microbiological detection system. The best way to get up to date and current news from BioLumix is to join us for weekly updates and discussions.

The BioLumix system offers many advantages to the microbiology lab with its innovative, space saving design and rapid yielding results. The basic system is composed of at least two instruments that read, incubate and monitor samples, offering real-time communication and auto-archiving of results. Software is 21 CFR Part 11 compliant and complete with a full audit trail including automatic log out when the computer is left idle for too long.

BioLumix customer service is our number one priority! We offer round the clock support with remote internet support provided via our home office in Ann Arbor, MI.

Want to hear what’s new at BioLumix? Scheduling a Visit? We love to have prospective companies visit us! Have Questions? Follow the link below to the Linked In website. Sign in with your LinkedIn ID and password and then you will be taken directly to the Rapid Microbiology Testing & Methods group, then click Join! It’s as simple as that to connect with other users of the BioLumix equipment and interested parties worldwide.

Please feel free to take advantage of the many social media sites we are participating in: Linked In, Twitter, Facebook and more.

For more information, please contact us at: (734) 984-3100 to speak to your sales representative, or feel free to email us at: Info@myBioLumix.com.

BioLumix Chapter in: Environmental Monitoring- A comprehensive Handbook- Volume 6

Edited by Jeanne Moldenhauer

The Environmental Monitoring series edited by Jeanne Moldenhauer provides guidance through the ins and outs of the multitudinous aspects of compliance. They are a must have for anyone involved in any way with environmental monitoring concerns. These six volumes, with 112 chapters written by subject matter experts worldwide, describe methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory. Each volume is different, as each speaks about separate environmental monitoring issues. Numerous useful protocols are included.

The 6 volume is an essential addition to this valuable series, offering current information about numerous subjects including environmental monitoring (E.M.) computerized systems, real-time clean room monitoring for total and viable particles, validation of a rapid system (BioLumix) for E.M. monitoring and water testing, practical and business approaches to microbial IDs, E.M. for non-sterile operations, objectionable microorganisms, neutralization of disinfectants in E.M. media, microbial characterization of E.M. samples and many more topics.

BioLumix Chapter 14: Validation of a rapid system for environmental monitoring and water testing; written by Ruth Eden and Roger Brideau includes an introduction to the BioLumix system, its sensorial and how microorganisms change color or fluorescence, the instrumentation and the software utilized. Following, is a detailed description of the validation work done to show the equivalency of the BioLumix automated system to the USP methodology. The chapter also shows how the BioLumix system can be used to monitor processing water for heterotrophic bacteria, coliform and E. coli.

BioLumix Microbial Limit Vial (MC)

Introduction:

The Microbial Limit vial is used to test primarily Personal Care, Cosmetic and over the counter Pharmaceutical (OTC) products for microbial content (contamination). Each of these types of products may have preservatives in their composition and the Microbial Limit vial helps to neutralize the inhibition of microbial growth that many preservatives provide. Neutralization of the preservative allows for a proper evaluation of whetheror not the product has contaminants. Often the contaminating bacteria in the product while in the presence of the preservative remain “injured” and unable to replicate. Thelack of replication might be interpreted as the lack of contamination.

How It Works

The Microbial Limit vial’s sensor detects production of CO2 by microorganisms, based upon the principle that CO2 is a universal metabolite produced by all microorganisms. The disposable vial contains a transparent solid sensor located at the bottom which changes its optical properties whenever CO2 diffuses into it. Only gases can penetrate the sensor; blocking liquids, microorganisms, and particulate matter. Consequently, the optical readings are not masked by the sample. CO2 generated by bacterial metabolism in the liquid medium diffuses into the sensor and interacts with an indicator reagent to provide an indication of the presence of the carbon dioxide.

Applications:

The Microbial Limit vial is used to test primarily Personal Care, Cosmetic and over the counter Pharmaceutical (OTC) products for microbial content (contamination). Each of these types of products may have preservatives in their composition and the Microbial Limit vial helps to neutralize the inhibition of microbial growth that many preservatives provide. Neutralization of the preservative allows for a proper evaluation of whether or not the product has contaminants. Often the contaminating bacteria in the product while in the presence of the preservative remain “injured” and unable to replicate. The lack of replication might be interpreted as the lack of contamination.

The first step of the assay is to perform a 1:10 dilution of the product in neutralizing broth such as D/E (Dey/Engley) broth, Letheen Broth, or TAT (Tryptone-Azolectin-Tween) Broth. There after 1.0-0.1 ml of the sample is added to the Microbial Limit vial. The Microbial Limit vial contains the neutralizers that inhibit many common preservatives and this neutralization event helps the customer to correctly measure the presence of contaminating organisms.

Examples of Growth Curves Using the Microbial Limit Vial:

In the curves shown below in the Figure, there is an example of both a positive curve and a negative curve. The bacterium used was Pseudomonas aeruginosa.

The BioLumix Microbial Limit vial was specifically designed to be used in complying with USP. Due to the fact the Microbial Limit vial has both Lecithin and Tween in its media composition helps allow for neutralization of the preservative in the sample to be maintained during the assay for viable organisms. Thus, this vial is useful to the customer that has already determined the amount of neutralizing buffer and its content of neutralizer to be used when the product sample is first prepared in diluent. Together the use of the correct neutralizer and the use of the BioLumix Microbial Limit vial helps ensure an accurate assay for the replicating organisms.

Table 1 summarizes the types of Products that customers test in the BioLumix Microbial Limit vial to measure the presence of organisms.

Summary:

The versatility of the BioLumix Microbial Limit vial includes the ability to support growth of most aerobic bacteria, many yeast and some mold organisms. In most cases YMC vial is used for the detection of yeast and molds. The BioLumix Microbial Limit vial can be used for determination of microbial content (contamination), for use in suitability studies that test whether a product can support growth of microorganisms, and in Preservative Efficacy Studies (PET analysis) that is used for cosmetic products. The BioLumix Microbial Limit vial can also be used by customers whose products include Dietary Supplements and Nutraceutical products for which preservatives (natural or chemical) are also added. Supplement products with natural preservatives also need to be neutralized and tested for their ability to support microbial growth.

Lactic Acid Bacteria Testing

Background

Lactic acid bacteria (LAB) is a group of Gram-positive, generally non sporulating, non-respiring rod or cocci. A common metabolic characteristic is their ability to produce lactic acid as a major metabolic end product of carbohydrate fermentation and their increased tolerance to grow at a lower pH range. This allows the LAB to partially outcompete other bacteria in natural fermentation, since they can withstand the increased acidity caused by the lactic acid production. All LAB grow anaerobically, but unlike most anaerobes, they grow in the presence of O2 as “aerotolerant anaerobes”. Because they obtain energy only from the metabolism of sugars, lactic acid bacteria are restricted to environments in which sugars are present.

LAB can spoil products or produce health benefits

A few LAB are pathogenic for animals, most notably some members of the genus Streptococcus. In humans, Streptococcus pyogenes is a major cause of disease (strep throat, pneumonia, and other pyogenic infections, scarlet fever and other toxemias), Streptococcus pneumoniae causes lobar pneumonia, otitis media and meningitis; some viridans and nonhemolytic oral streptococci play a role in dental caries and may be an insidious cause of endocarditis.

LAB can cause spoilage of a variety of foods including ready-to-eat meats, fish, vegetables, salad dressing, mayonnaise, and wine. There is no legal requirement to test for LAB in foods; however, quality-focused food manufacturers around the world choose to monitor lactic acid bacteria in their products and environments to ensure customer satisfaction of their product.

LAB are best known for their role in the preparation of fermented dairy products, pickling of vegetables, baking, wining making, curing fish, meats and sausages. For dairy manufacturing it involves a microbial process by which lactose is converted to lactic acid.

In yogurt, manufacture depends on a symbiotic relationship between two bacteria; Streptococcus thermophilus and Lactobacillus bulgaricus, where both species of bacteria help each other grow. The LAB created in this product can help supplement the normal healthy flora in the human intestine.

LAB are the most common microbes that are used as probiotics. The two primary probiotic bacteria used are members of the Lactobacillus and Bifidobacterium genera. Lactobacillus acidophilus is the most commonly used LAB. It ferments sugars into lactic acid, and can grow readily at lower pH values and has an optimum growth at 37C. Strains of this bacterium are used many in dairy products.

Current Methodology:

Currently the methodology to detect Lactic Acid Bacteria is one of the most time consuming and higher resource requiring media. To properly grow LAB in traditional methods most standard require the use of MRS Agar, APT, or Universal Beer Agar. Each sample tested using this method requires two plates of each media for a total of four plates. The plates also require an anaerobic chamber with a gas pack. The LAB then can require up to 7 days at 30C or 35C to grow. The plates have to be examined for growth and confirm the morphology of the colonies via gram staining. Sometimes further biochemical testing or identification techniques are required to complete the test.

BioLumix Methodology:

BioLumix has developed a Lactic Acid Bacteria vial that helps detect LAB in products. The LAB vial detects the presence of LAB using a modified version of MRS broth. The curves show four of the most common LAB (L. lactic, B. longum, L. acidophilus, and L. rhamnosus).

BioLumix has tested a variety of products using the LAB vial, such as mayonnaise, lunch meats, salad dressings, tartar sauce, yogurt, and enzymes. All products were tested both uninoculated and inoculated, and some products already contain LAB, such as yogurt (which in this case contained LABs such as L. Bulgaricus, S. Thermophillus, L. Acidophilus, Bifidus, and L. Casei). The BioLumix system can detect the LAB without interference from the products, which can be more difficult on traditional plating methods.

Advantages: The results of all these assays are available within 35-48 hours for most LAB and 72 hours for very slow growing LAB. The vial also can detect results in as early as 6 hours for some cultures. This is saves a substantial amount of time over the traditional seven days. Due to the depth of the broth in the vial no gas packs of unique environment is required. The system is fully automated including achieving of data, data maintenance and report generation, it can be used to create a paperless laboratory. The system is unaffected by product interference, delivering accurate results with faster product release. These assays are simpler to perform than the standard methods saving time, labor, and money.

November, 2009 : Event Announcement

BioLumix Validation WhitepaperAt Supply Side West 2009, BioLumix presented a Scientific White Paper entitled:Validation of The BioLumix System against USP Methodology.

Excerpt:

“To meet the challenges of the new FDA microbiological regulations requires simpler, faster and more streamlined tests. These tests have to comply with the methodology described in the relevant USP Chapters… The Validated BioLumix system allows companies to greatly reduce the amount of time and money required to have the samples tested.”

You can view the abstract or request a copy of the whitepaper here

November 2010 FDA Announcement!

NPM 2010 Logo

BioLumix met with FDA’s Center for Drug Evaluation and Research (CDER) personnel to present its new technology, answer questions and demonstrate how the BioLumix rapid, automated microbiology can be used in the Pharmaceutical industry.  The technology was warmly received by the CDER and BioLumix is encouraged by its ability to submit a Drug Master File (DMF). This will help to simplify and speed up the regulatory review process for companies adopting its technology.

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October 27-28, 2010 BioLumix exhibited at The Cosmetic Science Symposium & Expo which was sponsored by the Personal Care Products Council (Formerly CTFA)

NPM 2010 Logo The event attracted more than 300 industry leaders and decision-makers and offered personal care products industry staff one-stop shopping for information about Microbiology, Quality Assurance, Safety, and Environmental. There was a brief event announcement here.